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groups with high UV risk; citations; EU vs. EC, see Talk discussion
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A 2013 study concluded that the diligent, everyday application of sunscreen can slow or temporarily prevent the development of wrinkles and sagging skin. The study involved 900 [[light skin|white]] people in Australia and required some of them to apply a broad-spectrum sunscreen every day for four and a half years. It found that people who did so had noticeably more resilient and smoother skin than those assigned to continue their usual practices.<ref name=wrinkles/>
A 2013 study concluded that the diligent, everyday application of sunscreen can slow or temporarily prevent the development of wrinkles and sagging skin. The study involved 900 [[light skin|white]] people in Australia and required some of them to apply a broad-spectrum sunscreen every day for four and a half years. It found that people who did so had noticeably more resilient and smoother skin than those assigned to continue their usual practices.<ref name=wrinkles/>

Minimizing UV damage is especially important for children and fair-skinned individuals and those who have [[Photosensitivity in humans|sun sensitivity]] for medical reasons.<ref>{{cite web |url=http://ohioline.osu.edu/cd-fact/pdf/0199.pdf |author = Dresbach S.H., Brown W. |title = Ultraviolet Radiation |work = Ohioline Fact Sheet Series |volume = CDFS-199-08 |publisher = Ohio State University Extension |date=2008}}</ref>


=== Potential risks ===
=== Potential risks ===
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The SPF is an imperfect measure of skin damage because invisible damage and skin aging are also caused by [[ultraviolet]] type A (UVA, wavelength 315–400 or 320–400 [[nanometre|nm]]), which does not primarily cause reddening or pain. Conventional sunscreen blocks very little UVA radiation relative to the nominal SPF; broad-spectrum sunscreens are designed to protect against both UVB and UVA.<ref>{{cite pmid | 12118426}}</ref><ref>{{cite doi | 10.1046/j.1523-1747.2003.12498.x}}</ref><ref>{{cite doi | 10.1016/j.jaad.2007.04.035}}</ref> According to a 2004 study, UVA also causes [[DNA]] damage to cells deep within the skin, increasing the risk of [[malignant melanoma]]s.<ref>{{cite journal | author=Berneburg M, Plettenberg H, Medve-König K, Pfahlberg A, Gers-Barlag H, Gefeller O, Krutmann J | title=Induction of the photoaging-associated mitochondrial common deletion in vivo in normal human skin | journal=J Invest Dermatol | volume=122 | issue=5 | pages=1277–83 | year=2004 | pmid=15140232 | doi=10.1111/j.0022-202X.2004.22502.x}}</ref> Even some products labeled "broad-spectrum UVA/UVB protection" do not provide good protection against UVA rays.<ref>[http://msnbc.msn.com/id/12081374/ MSNBC.com : Sunscreen — protection or 'snake oil?']</ref> [[Titanium dioxide]] probably gives good protection, but does not completely cover the UVA spectrum, as early 2000s research suggests that zinc oxide is superior to titanium dioxide at wavelengths between 340 and 380&nbsp;nm.<ref>{{cite journal | author=Pinnell SR, Fairhurst D, Gillies R, Mitchnick MA, Kollias N | title=Microfine zinc oxide is a superior sunscreen ingredient to microfine titanium dioxide | journal=Dermatol Surg | volume=26 | issue=4 | pages=309–14 |date=April 2000 | pmid=10759815 | doi= 10.1046/j.1524-4725.2000.99237.x | url=http://www.blackwell-synergy.com/openurl?genre=article&sid=nlm:pubmed&issn=1076-0512&date=2000&volume=26&issue=4&spage=309}} {{deadlink|date=July 2014}}</ref>
The SPF is an imperfect measure of skin damage because invisible damage and skin aging are also caused by [[ultraviolet]] type A (UVA, wavelength 315–400 or 320–400 [[nanometre|nm]]), which does not primarily cause reddening or pain. Conventional sunscreen blocks very little UVA radiation relative to the nominal SPF; broad-spectrum sunscreens are designed to protect against both UVB and UVA.<ref>{{cite pmid | 12118426}}</ref><ref>{{cite doi | 10.1046/j.1523-1747.2003.12498.x}}</ref><ref>{{cite doi | 10.1016/j.jaad.2007.04.035}}</ref> According to a 2004 study, UVA also causes [[DNA]] damage to cells deep within the skin, increasing the risk of [[malignant melanoma]]s.<ref>{{cite journal | author=Berneburg M, Plettenberg H, Medve-König K, Pfahlberg A, Gers-Barlag H, Gefeller O, Krutmann J | title=Induction of the photoaging-associated mitochondrial common deletion in vivo in normal human skin | journal=J Invest Dermatol | volume=122 | issue=5 | pages=1277–83 | year=2004 | pmid=15140232 | doi=10.1111/j.0022-202X.2004.22502.x}}</ref> Even some products labeled "broad-spectrum UVA/UVB protection" do not provide good protection against UVA rays.<ref>[http://msnbc.msn.com/id/12081374/ MSNBC.com : Sunscreen — protection or 'snake oil?']</ref> [[Titanium dioxide]] probably gives good protection, but does not completely cover the UVA spectrum, as early 2000s research suggests that zinc oxide is superior to titanium dioxide at wavelengths between 340 and 380&nbsp;nm.<ref>{{cite journal | author=Pinnell SR, Fairhurst D, Gillies R, Mitchnick MA, Kollias N | title=Microfine zinc oxide is a superior sunscreen ingredient to microfine titanium dioxide | journal=Dermatol Surg | volume=26 | issue=4 | pages=309–14 |date=April 2000 | pmid=10759815 | doi= 10.1046/j.1524-4725.2000.99237.x | url=http://www.blackwell-synergy.com/openurl?genre=article&sid=nlm:pubmed&issn=1076-0512&date=2000&volume=26&issue=4&spage=309}} {{deadlink|date=July 2014}}</ref>


Owing to consumer confusion over the real degree and duration of protection offered, labeling restrictions are in force in several countries. In the [[European Union|EU]], sunscreen labels can only go up to SPF 50+ (initially listed as 30 but soon revised to 50).<ref>{{cite journal | url=http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006H0647:EN:NOT | title=Commission Recommendation of 22 September 2006 on the efficacy of sunscreen products and the claims made relating thereto | publisher=Official Journal of the European Union | date=2006-09-22 | accessdate=2009-09-25}}</ref> [[Australia]]'s [[Therapeutic Goods Administration]] increased the upper limit to 50+ in 2012.<ref>{{cite web | url=http://www.arpansa.gov.au/uvrg/rginfo_p13.cfm | title=UV Resource Guide - Sunscreens | publisher=Arpansa | date=2008-12-20 | accessdate=2009-09-25}}</ref><ref>{{cite web | url=http://www.cancer.org.au/preventing-cancer/sun-protection/preventing-skin-cancer/spf50sunscreen.html | title=SPF50+ Sunscreen | date=2013-02-01 | accessdate=2014-02-06}}</ref> In the 2007 and 2011 draft rules, the [[Food and Drug Administration]] (FDA) proposed a maximum SPF label of 50, to limit unrealistic claims.<ref>[http://www.fda.gov/cder/drug/infopage/sunscreen/qa.htm Questions and Answers on the 2007 Sunscreen Proposed Rule<!-- Bot generated title -->]</ref><ref name="fda2011">{{cite web | url=http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/ucm258468.htm | title=Questions and Answers: FDA announces new requirements for over-the-counter (OTC) sunscreen products marketed in the U.S. | date=2011-06-23 | accessdate=2012-04-10}}</ref><ref>{{cite journal|title=Revised Effectiveness Determination; Sunscreen Drug Products for Over-the-Counter Human Use|journal=[[Federal Register]]|date=17 June 2011|volume=76|issue=117|pages=35672–35678|url=http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/UCM313542.pdf|accessdate=21 November 2013|author=Department of Health and Human Services: Food and Drug Administration}}</ref> Others have proposed restricting the active ingredients to an SPF of no more than 50, due to lack of evidence that higher dosages provide more meaningful protection.<ref name="onpoint">{{cite web | url=http://onpoint.wbur.org/2011/06/16/sunscreen | date=2011-06-16 | accessdate=2012-04-10 | title=Sunscreen Takes Some Heat: New Dangers, New Rules}}</ref>
Owing to consumer confusion over the real degree and duration of protection offered, labeling restrictions are in force in several countries. In the [[European Union|EU]], sunscreen labels can only go up to SPF 50+ (initially listed as 30 but soon revised to 50).<ref>{{cite journal | url=http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006H0647:EN:NOT | title=Commission Recommendation of 22 September 2006 on the efficacy of sunscreen products and the claims made relating thereto | publisher=Official Journal of the European Union | date=2006-09-22 | accessdate=2009-09-25}}</ref> [[Australia]]'s [[Therapeutic Goods Administration]] increased the upper limit to 50+ in 2012.<ref>{{cite web | url=http://www.arpansa.gov.au/uvrg/rginfo_p13.cfm | title=UV Resource Guide - Sunscreens | publisher=Arpansa | date=2008-12-20 | accessdate=2009-09-25}}</ref><ref>{{cite web | url=http://www.cancer.org.au/preventing-cancer/sun-protection/preventing-skin-cancer/spf50sunscreen.html | title=SPF50+ Sunscreen | date=2013-02-01 | accessdate=2014-02-06}}</ref> In the 2007 and 2011 draft rules, the [[Food and Drug Administration]] (FDA) proposed a maximum SPF label of 50, to limit unrealistic claims.<ref name="qa2007">[http://www.fda.gov/cder/drug/infopage/sunscreen/qa.htm Questions and Answers on the 2007 Sunscreen Proposed Rule]</ref><ref name="fda2011">{{cite web | url=http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/ucm258468.htm | title=Questions and Answers: FDA announces new requirements for over-the-counter (OTC) sunscreen products marketed in the U.S. | date=2011-06-23 | accessdate=2012-04-10}}</ref><ref>{{cite journal|title=Revised Effectiveness Determination; Sunscreen Drug Products for Over-the-Counter Human Use|journal=[[Federal Register]]|date=17 June 2011|volume=76|issue=117|pages=35672–35678|url=http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/UCM313542.pdf|accessdate=21 November 2013|author=Department of Health and Human Services: Food and Drug Administration}}</ref> Others have proposed restricting the active ingredients to an SPF of no more than 50, due to lack of evidence that higher dosages provide more meaningful protection.<ref name="onpoint">{{cite web | url=http://onpoint.wbur.org/2011/06/16/sunscreen | date=2011-06-16 | accessdate=2012-04-10 | title=Sunscreen Takes Some Heat: New Dangers, New Rules}}</ref>


[[Image:erythemal action spectrum.svg|thumb | 300px | UV sunlight spectrum (on a summer day in the Netherlands), along with the CIE Erythemal action spectrum. The effective spectrum is the product of the former two.]]
[[Image:erythemal action spectrum.svg|thumb | 300px | UV sunlight spectrum (on a summer day in the Netherlands), along with the CIE Erythemal action spectrum. The effective spectrum is the product of the former two.]]
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One-star products provide the least ratio of UVA protection; five-star products are best. The method has recently been revised in the light of the Colipa UVA PF test, and with the new EU recommendations regarding UVA PF. The method still uses a [[spectrophotometer]] to measure absorption of UVA versus UVB; the difference stems from a requirement to pre-irradiate samples (where this was not previously required) to give a better indication of UVA protection, and of photostability when the product is used. With the current methodology, the lowest rating is three stars, the highest being five stars.
One-star products provide the least ratio of UVA protection; five-star products are best. The method has recently been revised in the light of the Colipa UVA PF test, and with the new EU recommendations regarding UVA PF. The method still uses a [[spectrophotometer]] to measure absorption of UVA versus UVB; the difference stems from a requirement to pre-irradiate samples (where this was not previously required) to give a better indication of UVA protection, and of photostability when the product is used. With the current methodology, the lowest rating is three stars, the highest being five stars.


In August 2007, the FDA put out for consultation the proposal that a version of this protocol be used to inform users of American product of the protection that it gives against UVA,<ref>[http://www.fda.gov/cder/drug/infopage/sunscreen/qa.htm Questions and Answers on the 2007 Sunscreen Proposed Rule]</ref> but after concern this would be too confusing this was not adopted.<ref name="onpoint" />
In August 2007, the FDA put out for consultation the proposal that a version of this protocol be used to inform users of American product of the protection that it gives against UVA,<ref name="qa2007"/> but after concern this would be too confusing this was not adopted.<ref name="onpoint" />


==== PA system ====
==== PA system ====
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| [[p-Aminobenzoic acid]]
| [[p-Aminobenzoic acid]]
| PABA
| PABA
| 15% (EC: banned from sale to consumers from 8 October 2009)
| 15% (EU: banned from sale to consumers from 8 October 2009)
| USA, AUS
| USA, AUS
| Protects against skin tumors in mice.<ref>{{cite journal| authors= H Flindt-Hansen; P. Thune; T. Eeg-Larsen|title=The inhibiting effect of PABA on photocarcinogenesis |journal=Archives of Dermatological Research|volume=282|pages=38–41|year=1990|doi=10.1007/BF00505643| pmid= 2317082| issue= 1}}</ref><ref>{{cite journal| authors= H Flindt-Hansen; P. Thune; T. Eeg-Larsen|title= The effect of short-term application of PABA on photocarcinogenesis |journal= Acta Derm Venerol.|volume=70|pages=72–75|year=1990| pmid= 1967881| issue= 1}}</ref><ref name="Sensitization">{{cite journal| authors=P. J. Osgood; S. H. Moss; D. J. Davies| title=The sensitization of near-ultraviolet radiation killing of mammalian cells by the sunscreen agent para-aminobenzoic acid| journal=Journal of Investigative Dermatology| volume=79| issue=6| pages=354–357| year=1982| doi=10.1111/1523-1747.ep12529409| pmid=6982950}}</ref> Shown to increase DNA defects, however, and is now less commonly used.
| Protects against skin tumors in mice.<ref>{{cite journal| authors= H Flindt-Hansen; P. Thune; T. Eeg-Larsen|title=The inhibiting effect of PABA on photocarcinogenesis |journal=Archives of Dermatological Research|volume=282|pages=38–41|year=1990|doi=10.1007/BF00505643| pmid= 2317082| issue= 1}}</ref><ref>{{cite journal| authors= H Flindt-Hansen; P. Thune; T. Eeg-Larsen|title= The effect of short-term application of PABA on photocarcinogenesis |journal= Acta Derm Venerol.|volume=70|pages=72–75|year=1990| pmid= 1967881| issue= 1}}</ref><ref name="Sensitization">{{cite journal| authors=P. J. Osgood; S. H. Moss; D. J. Davies| title=The sensitization of near-ultraviolet radiation killing of mammalian cells by the sunscreen agent para-aminobenzoic acid| journal=Journal of Investigative Dermatology| volume=79| issue=6| pages=354–357| year=1982| doi=10.1111/1523-1747.ep12529409| pmid=6982950}}</ref> Shown to increase DNA defects, however, and is now less commonly used.
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| [[Padimate O]]
| [[Padimate O]]
| OD-PABA, octyldimethyl-PABA, σ-PABA
| OD-PABA, octyldimethyl-PABA, σ-PABA
| 8% (EC, USA, AUS) 10% (JP)
| 8% (EU, USA, AUS) 10% (JP)
(Not currently supported in EC and may be delisted)
(Not currently supported in EU and may be delisted)
| EC, USA, AUS, JP
| EU, USA, AUS, JP
|
|
|-
|-
| [[Phenylbenzimidazole sulfonic acid]]
| [[Phenylbenzimidazole sulfonic acid]]
| Ensulizole, Eusolex 232, PBSA, Parsol HS
| Ensulizole, Eusolex 232, PBSA, Parsol HS
| 4% (US, AUS) 8% (EC) 3% (JP)
| 4% (US, AUS) 8% (EU) 3% (JP)
| EC, USA, AUS, JP
| EU, USA, AUS, JP
| Genotoxic in bacteria<ref name="Mosley2007">{{cite journal |year= 2007 |month= |title= Light-Induced Cytotoxicity and Genotoxicity of a Sunscreen Agent, 2-Phenylbenzimidazol in Salmonella typhimurium TA 102 and HaCaT Keratinocytes |journal= International Journal of Environmental Research and Public Health |volume= 4 |issue= 2 |pages=126–131 |id= |url= |doi=10.3390/ijerph2007040006 |author1= Mosley, C N |author2= Wang, L |author3= Gilley, S |author4= Wang, S |author5= Yu, H |pmid= 17617675}}</ref>
| Genotoxic in bacteria<ref name="Mosley2007">{{cite journal |year= 2007 |month= |title= Light-Induced Cytotoxicity and Genotoxicity of a Sunscreen Agent, 2-Phenylbenzimidazol in Salmonella typhimurium TA 102 and HaCaT Keratinocytes |journal= International Journal of Environmental Research and Public Health |volume= 4 |issue= 2 |pages=126–131 |id= |url= |doi=10.3390/ijerph2007040006 |author1= Mosley, C N |author2= Wang, L |author3= Gilley, S |author4= Wang, S |author5= Yu, H |pmid= 17617675}}</ref>
|-
|-
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| [[Oxybenzone]]
| [[Oxybenzone]]
| Benzophenone-3, Eusolex 4360, Escalol 567
| Benzophenone-3, Eusolex 4360, Escalol 567
| 6% (US) 10% (AUS, EC) 5% (JP)
| 6% (US) 10% (AUS, EU) 5% (JP)
| EC, USA, AUS, JP
| EU, USA, AUS, JP
|
|
|-
|-
| [[Homosalate]]
| [[Homosalate]]
| Homomethyl salicylate, HMS
| Homomethyl salicylate, HMS
| 10% (EC, JP) 15% (US, AUS)
| 10% (EU, JP) 15% (US, AUS)
| EC, USA, AUS, JP
| EU, USA, AUS, JP
|
|
|-
|-
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| Eusolex OCR, 2-Cyano-3,3-diphenyl acrylic acid, 2-ethylhexylester
| Eusolex OCR, 2-Cyano-3,3-diphenyl acrylic acid, 2-ethylhexylester
| 10%
| 10%
| EC, USA, AUS, JP
| EU, USA, AUS, JP
| Increases ROS<ref name="Hanson" />
| Increases ROS<ref name="Hanson" />
|-
|-
| [[Octyl methoxycinnamate]]
| [[Octyl methoxycinnamate]]
| Octinoxate, EMC, OMC, Ethylhexyl methoxycinnamate, Escalol 557, 2-Ethylhexyl-paramethoxycinnamate, Parsol MCX
| Octinoxate, EMC, OMC, Ethylhexyl methoxycinnamate, Escalol 557, 2-Ethylhexyl-paramethoxycinnamate, Parsol MCX
| 7.5% (US) 10% (EC, AUS) 20% (JP)
| 7.5% (US) 10% (EU, AUS) 20% (JP)
| EC, USA, AUS, JP
| EU, USA, AUS, JP
|
|
|-
|-
| [[Octyl salicylate]]
| [[Octyl salicylate]]
| Octisalate, 2-Ethylhexyl salicylate, Escalol 587,
| Octisalate, 2-Ethylhexyl salicylate, Escalol 587,
| 5% (EC, USA, AUS) 10% (JP)
| 5% (EU, USA, AUS) 10% (JP)
| EC, USA, AUS, JP
| EU, USA, AUS, JP
|
|
|-
|-
| [[Sulisobenzone]]
| [[Sulisobenzone]]
| 2-Hydroxy-4-Methoxybenzophenone-5-sulfonic acid, 3-Benzoyl-4-hydroxy-6-methoxybenzenesulfonic acid, Benzophenone-4, Escalol 577
| 2-Hydroxy-4-Methoxybenzophenone-5-sulfonic acid, 3-Benzoyl-4-hydroxy-6-methoxybenzenesulfonic acid, Benzophenone-4, Escalol 577
| 5% (EC) 10% (US, AUS, JP)
| 5% (EU) 10% (US, AUS, JP)
| EC, USA, AUS, JP
| EU, USA, AUS, JP
|
|
|-
|-
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| [[Avobenzone]]
| [[Avobenzone]]
| 1-(4-methoxyphenyl)-3-(4-tert-butyl<br>phenyl)propane-1,3-dione, Butyl methoxy dibenzoylmethane, BMDBM, Parsol 1789, Eusolex 9020
| 1-(4-methoxyphenyl)-3-(4-tert-butyl<br>phenyl)propane-1,3-dione, Butyl methoxy dibenzoylmethane, BMDBM, Parsol 1789, Eusolex 9020
| 3% (US) 5% (EC, AUS)10% (JP)
| 3% (US) 5% (EU, AUS)10% (JP)
| EC, USA, AUS, JP
| EU, USA, AUS, JP
| Not available<ref>{{cite journal|title=Human Safety and Efficacy of Ultraviolet Filters and Sunscreen Products|journal=Dermatologic Clinics|volume=24|pages=35–51|year=2006|doi=10.1016/j.det.2005.09.006|pmid=16311166|last1=Nash|first1=JF|issue=1}}</ref>
| Not available<ref>{{cite journal|title=Human Safety and Efficacy of Ultraviolet Filters and Sunscreen Products|journal=Dermatologic Clinics|volume=24|pages=35–51|year=2006|doi=10.1016/j.det.2005.09.006|pmid=16311166|last1=Nash|first1=JF|issue=1}}</ref>
|-
|-
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| Mexoryl SX, Terephthalylidene Dicamphor Sulfonic Acid
| Mexoryl SX, Terephthalylidene Dicamphor Sulfonic Acid
| 10%
| 10%
| EC, AUS (US: approved in certain formulations up to 3% via New Drug Application (NDA) Route)
| EU, AUS (US: approved in certain formulations up to 3% via New Drug Application (NDA) Route)
| Protects against skin tumors in mice<ref name="autogenerated1">{{cite journal |title= photoprotection | journal= Lancet |volume=370 |pages=528–37 |year=2007 |doi=10.1016/S0140-6736(07)60638-2 |author1= Lautenschlager, Stephan |author2= Wulf, Hans Christian |author3= Pittelkow, Mark R |pmid= 17693182 |issue= 9586}}</ref><ref>{{cite journal| title=Percutaneous absorption of Mexoryl SX in human volunteers: comparison with in vitro data|date=Nov–Dec 2003| pmid=14528058| author=Benech-Kieffer F, Meuling WJ, Leclerc C, Roza L, Leclaire J, Nohynek G| journal= Skin Pharmacol Appl Skin Physiol| volume=16| pages=343–55| doi=10.1159/000072929| issue=6}}</ref><ref>{{cite journal| title=Mexoryl SX protects against solar-simulated UVR-induced photocarcinogenesis in mice|date=October 1996| pmid=8863475| author=Fourtanier A| journal= Photochem Photobiol| volume=64| pages=688–93| doi=10.1111/j.1751-1097.1996.tb03125.x| issue=4}}</ref>
| Protects against skin tumors in mice<ref name="autogenerated1">{{cite journal |title= photoprotection | journal= Lancet |volume=370 |pages=528–37 |year=2007 |doi=10.1016/S0140-6736(07)60638-2 |author1= Lautenschlager, Stephan |author2= Wulf, Hans Christian |author3= Pittelkow, Mark R |pmid= 17693182 |issue= 9586}}</ref><ref>{{cite journal| title=Percutaneous absorption of Mexoryl SX in human volunteers: comparison with in vitro data|date=Nov–Dec 2003| pmid=14528058| author=Benech-Kieffer F, Meuling WJ, Leclerc C, Roza L, Leclaire J, Nohynek G| journal= Skin Pharmacol Appl Skin Physiol| volume=16| pages=343–55| doi=10.1159/000072929| issue=6}}</ref><ref>{{cite journal| title=Mexoryl SX protects against solar-simulated UVR-induced photocarcinogenesis in mice|date=October 1996| pmid=8863475| author=Fourtanier A| journal= Photochem Photobiol| volume=64| pages=688–93| doi=10.1111/j.1751-1097.1996.tb03125.x| issue=4}}</ref>
|-
|-
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| CI77891
| CI77891
| 25% (No limit Japan)
| 25% (No limit Japan)
| EC, USA, AUS, JP
| EU, USA, AUS, JP
|
|
|-
|-
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|
|
| 25% (US) 20% (AUS)
| 25% (US) 20% (AUS)
(EC: 25%, provided particle size >100&nbsp;nm)
(EU: 25%, provided particle size >100&nbsp;nm)
(Japan: no limit)
(Japan: no limit)
| EC, USA, AUS, JP
| EU, USA, AUS, JP
| Protects against skin tumors in mice<ref name="autogenerated1" />
| Protects against skin tumors in mice<ref name="autogenerated1" />
|}
|}
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| Enzacamene, Parsol 5000, Eusolex 6300, MBC
| Enzacamene, Parsol 5000, Eusolex 6300, MBC
| 4%<sup>*</sup>
| 4%<sup>*</sup>
| EC, AUS
| EU, AUS
|-
|-
| [[Bisoctrizole|Tinosorb M]]
| [[Bisoctrizole|Tinosorb M]]
| Bisoctrizole, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol, MBBT
| Bisoctrizole, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol, MBBT
| 10%<sup>*</sup>
| 10%<sup>*</sup>
| EC, AUS, JP
| EU, AUS, JP
|-
|-
| [[Bemotrizinol|Tinosorb S]]
| [[Bemotrizinol|Tinosorb S]]
| Bis-ethylhexyloxyphenol methoxyphenol triazine, Bemotrizinol, BEMT, anisotriazine
| Bis-ethylhexyloxyphenol methoxyphenol triazine, Bemotrizinol, BEMT, anisotriazine
| 10% (EC, AUS) 3% (JP)<sup>*</sup>
| 10% (EU, AUS) 3% (JP)<sup>*</sup>
| EC, AUS, JP
| EU, AUS, JP
|-
|-
| [[Bisdisulizole disodium|Neo Heliopan AP]]
| [[Bisdisulizole disodium|Neo Heliopan AP]]
| Bisdisulizole Disodium, Disodium phenyl dibenzimidazole tetrasulfonate, bisimidazylate, DPDT
| Bisdisulizole Disodium, Disodium phenyl dibenzimidazole tetrasulfonate, bisimidazylate, DPDT
| 10%
| 10%
| EC, AUS
| EU, AUS
|-
|-
| [[Drometrizole trisiloxane|Mexoryl XL]]
| [[Drometrizole trisiloxane|Mexoryl XL]]
| Drometrizole Trisiloxane
| Drometrizole Trisiloxane
| 15%
| 15%
| EC, AUS
| EU, AUS
|-
|-
| [[Benzophenone-9]]
| [[Benzophenone-9]]
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| [[Ethylhexyl triazone|Uvinul T 150]]
| [[Ethylhexyl triazone|Uvinul T 150]]
| Octyl triazone, ethylhexyl triazone, EHT
| Octyl triazone, ethylhexyl triazone, EHT
| 5% (EC, AUS) 3% (JP)<sup>*</sup>
| 5% (EU, AUS) 3% (JP)<sup>*</sup>
| EC, AUS
| EU, AUS
|-
|-
| [[Diethylamino hydroxybenzoyl hexyl benzoate|Uvinul A Plus]]
| [[Diethylamino hydroxybenzoyl hexyl benzoate|Uvinul A Plus]]
| Diethylamino Hydroxybenzoyl Hexyl Benzoate
| Diethylamino Hydroxybenzoyl Hexyl Benzoate
| 10% (EC,JP)
| 10% (EU,JP)
| EC, JP
| EU, JP
|-
|-
| [[Iscotrizinol|Uvasorb HEB]]
| [[Iscotrizinol|Uvasorb HEB]]
| Iscotrizinol, Diethylhexyl butamido triazone, DBT
| Iscotrizinol, Diethylhexyl butamido triazone, DBT
| 10% (EC) 5% (JP)<sup>*</sup>
| 10% (EU) 5% (JP)<sup>*</sup>
| EC, JP
| EU, JP
|-
|-
| [[Polysilicone-15|Parsol SLX]]
| [[Polysilicone-15|Parsol SLX]]
| Dimethico-diethylbenzalmalonate, Polysilicone-15
| Dimethico-diethylbenzalmalonate, Polysilicone-15
| 10%
| 10%
| EC, AUS, JP
| EU, AUS, JP
|-
|-
| [[Amiloxate]]
| [[Amiloxate]]
| Isopentyl-4-methoxycinnamate, Isoamyl p-Methoxycinnamate, IMC, Neo Heliopan E1000
| Isopentyl-4-methoxycinnamate, Isoamyl p-Methoxycinnamate, IMC, Neo Heliopan E1000
| 10%<sup>*</sup>
| 10%<sup>*</sup>
| EC, AUS
| EU, AUS
|}
|}


Line 303: Line 305:


== Other FDA labeling regulations ==
== Other FDA labeling regulations ==
Sunscreen [[labeling]] standards have been evolving in the United States since the FDA first adopted the SPF calculation in 1978.<ref>{{cite journal |url=http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm090127.pdf |title=Sunscreen Drug Products for Over-the-Counter Human Use |journal=[[Federal Register]] |author=Department of Health and Human Services: Food and Drug Administration |volume=43 |issue=166 |pages=38206–38269 |date=August 25, 1978 |accessdate=July 30, 2014}}</ref> The FDA issued a comprehensive set of rules in June 2011, taking effect in 2012–2013, designed to help consumers identify and select suitable sunscreen products offering protection from sunburn, early skin aging, and skin cancer:<ref name="fda2011" /><ref>[http://www.gpo.gov/fdsys/pkg/FR-2012-05-11/pdf/2012-11390.pdf Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Delay of Compliance Dates] Retrieved 09/27/2012</ref><ref>[http://newsletter.sgs.com/eNewsletterPro/uploadedimages/000006/sgs-safeguards-10412-us-fda-extends-deadline-for-new-sunscreen-labeling-requirements-a4-en-12.pdf US FDA Delays Implementation Deadlines for Sunscreen Labeling Requirements] SGS SafeGuards Bulletin, Retrieved 09/27/2012</ref>
Sunscreen [[labeling]] standards have been evolving in the United States since the FDA first adopted the SPF calculation in 1978.<ref>{{cite journal |url=http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm090127.pdf |title=Sunscreen Drug Products for Over-the-Counter Human Use |journal=[[Federal Register]] |author=Department of Health and Human Services: Food and Drug Administration |volume=43 |issue=166 |pages=38206–38269 |date=August 25, 1978 |accessdate=July 30, 2014}}</ref> The FDA issued a comprehensive set of rules in June 2011, taking effect in 2012–2013, designed to help consumers identify and select suitable sunscreen products offering protection from sunburn, early skin aging, and skin cancer:<ref name="fda2011" /><ref>{{cite journal|title=Sunscreen Drug Products for Over-the-Counter Human Use; Final Rules and Proposed Rules|journal=[[Federal Register]]|date=June 17, 2011|volume=76|issue=117|pages=35620–35665|url=http://www.gpo.gov/fdsys/pkg/FR-2011-06-17/pdf/2011-14766.pdf|accessdate=August 19, 2014|author=Department of Health and Human Services: Food and Drug Administration}}</ref><ref>[http://www.gpo.gov/fdsys/pkg/FR-2012-05-11/pdf/2012-11390.pdf Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Delay of Compliance Dates] Retrieved 09/27/2012</ref><ref>[http://newsletter.sgs.com/eNewsletterPro/uploadedimages/000006/sgs-safeguards-10412-us-fda-extends-deadline-for-new-sunscreen-labeling-requirements-a4-en-12.pdf US FDA Delays Implementation Deadlines for Sunscreen Labeling Requirements] SGS SafeGuards Bulletin, Retrieved 09/27/2012</ref>
* To be classified as "broad spectrum", sunscreen products must provide protection against both [[Ultraviolet A|UVA]] and [[UVB]], with specific tests required for both.
* To be classified as "broad spectrum", sunscreen products must provide protection against both [[Ultraviolet A|UVA]] and [[UVB]], with specific tests required for both.
* Claims of products being "[[waterproof]]" or "sweatproof" are prohibited, while "sunblock" and "instant protection" and "protection for more than 2 hours" are all prohibited without specific FDA approval.
* Claims of products being "[[waterproof]]" or "sweatproof" are prohibited, while "sunblock" and "instant protection" and "protection for more than 2 hours" are all prohibited without specific FDA approval.

Revision as of 10:59, 19 August 2014

Sunscreen (also commonly known as sun screen, sunblock, suntan lotion, sunburn cream, sun cream or block out)[1] is a lotion, spray, gel or other topical product that absorbs or reflects some of the sun's ultraviolet (UV) radiation on the skin exposed to sunlight and thus helps protect against sunburn. Skin-lightening products have sunscreen to protect lightened skin because light skin is more susceptible to sun damage than darker skin. A number of sunscreens have tanning powder to help the skin to darken or tan; however, tanning powder does not provide protection from UV rays.

Depending on the mode of action, sunscreens can be classified into physical sunscreens (i.e., those that reflect the sunlight) or chemical sunscreens (i.e., those that absorb the UV light).[2]

Medical organizations such as the American Cancer Society recommend the use of sunscreen because it aids in the prevention of developing squamous cell carcinomas.[3] Many sunscreens do not block UVA radiation, which does not primarily cause sunburn but can increase the rate of melanoma and photodermatitis, so people using sunscreens may be exposed to high UVA levels without realizing it.[4] The use of broad-spectrum (UVA/UVB) sunscreens can address this concern. Diligent use of sunscreen can also slow or temporarily prevent the development of wrinkles and sagging skin.[5]

Health effects

Benefits

Sunscreen use can help prevent melanoma[6] and squamous cell carcinoma, two types of skin cancer.[7] There is little evidence that it is effective in preventing basal cell carcinoma.[8]

A 2013 study concluded that the diligent, everyday application of sunscreen can slow or temporarily prevent the development of wrinkles and sagging skin. The study involved 900 white people in Australia and required some of them to apply a broad-spectrum sunscreen every day for four and a half years. It found that people who did so had noticeably more resilient and smoother skin than those assigned to continue their usual practices.[5]

Minimizing UV damage is especially important for children and fair-skinned individuals and those who have sun sensitivity for medical reasons.[9]

Potential risks

In 2008 two studies by the CDC highlighted concerns about the sunscreen chemical oxybenzone (benzophenone-3). The first study detected the chemical in 97% of the 2,500 Americans tested, while the second found that mothers with high levels of oxybenzone in their bodies were more likely to give birth to underweight baby girls.[10] While controversial, oxybenzone does provide broad-spectrum UV coverage, including UVB and short-wave UVA rays.[7]

In 2006 the Therapeutic Goods Administration of Australia carried out a review of sunscreen safety studies and concluded: "There is evidence from isolated cell experiments that zinc oxide and titanium dioxide can induce free radical formation in the presence of light and that this may damage these cells (photo-mutagenicity with zinc oxide). However, this would only be of concern in people using sunscreens if the zinc oxide and titanium dioxide penetrated into viable skin cells. The weight of current evidence is that they remain on the surface of the skin and in the outer dead layer (stratum corneum) of the skin."[11]

Concerns have also been raised about potential vitamin D deficiency arising from prolonged use of sunscreen. Typical use of sunscreen does not usually result in vitamin D deficiency; however, extensive usage may.[12] Sunscreen prevents ultraviolet light from reaching the skin and if properly applied will, under high UV Index conditions, approximately halve vitamin D synthesis; whether the effect is exacerbated under low UV intensity is not yet proven.[13][14] When the UV Index is greater than 3 (which occurs daily within the tropics and daily during the spring and summer seasons in temperate regions), adequate amounts of vitamin D3 can be made in the skin after only ten to fifteen minutes of sun exposure at least two times per week to the face, arms, hands, or back without sunscreen. With longer exposure to UVB rays, an equilibrium is achieved in the skin, and the vitamin degrades as fast as it is generated.[15]

History

Early civilizations used a variety of plant products to help protect the skin from sun damage. For example, ancient Greeks used olive oil for this purpose, and ancient Egyptians used extracts of rice, jasmine, and lupine plants whose products are still used in skin care today.[16] Zinc oxide paste has also been popular for skin protection for thousands of years.[17][18]

Early synthetic sunscreens were first used in 1928, and the first major commercial product was brought to market in 1936, introduced by the founder of L'Oreal, French chemist Eugène Schueller. During the same period, Hamilton Sunscreen came to the Australian market in 1932, developed by chemist H. A. Milton Blake.[16][19]

Among widely used modern sunscreens, one of the earliest was produced in 1944 for the US military by Benjamin Green, an airman and later a pharmacist, as the hazards of sun overexposure became apparent to soldiers in the Pacific tropics at the height of World War II.[19][20][21][22] The product, named Red Vet Pet (for red veterinary petrolatum), had limited effectiveness, working as a physical blocker of ultraviolet radiation. It was a disagreeable red, sticky substance similar to petroleum jelly. Sales boomed when Coppertone improved and commercialized the substance under the Coppertone girl and Bain de Soleil branding in the early 1950s.

In 1946, Swiss chemist Franz Greiter introduced what may have been the first effective modern sunscreen. The product, called Gletscher Crème (Glacier Cream), subsequently became the basis for the company Piz Buin (named in honor of the place Greiter allegedly obtained the sunburn that inspired his concoction), which is still today a marketer of sunscreen products.[16][23][24] In 1974, Greiter adapted earlier calculations from Friedrich Ellinger and Rudolf Schulze and introduced the "sun protection factor" (SPF), which has become a worldwide standard for measuring the effectiveness of sunscreen.[21][25] It has been estimated that Gletscher Crème had a sun protection factor of 2.

Water-resistant sunscreens were introduced in 1977,[19] and recent development efforts have focused on making sunscreen protection both longer-lasting and broader-spectrum, as well as more appealing to use.[21]

Measurements of sunscreen protection

Sunscreen helps prevent sunburn, such as this, which has blistered

Sun protection factor (SPF) and labeling requirements

Two photographs showing the effect of applying sunscreens in visible light and in UVA. The photograph on the right was taken using ultraviolet photography shortly after application of sunscreen to half of the face.

The SPF rating is a measure of the fraction of sunburn-producing UV rays blocked. For example, "SPF 15" means that 1/15th of the burning radiation will reach the skin, assuming sunscreen is applied evenly at a thick dosage of 2 milligrams per square centimeter (mg/cm2). A user can determine the effectiveness of a sunscreen "by multiplying the SPF factor by the length of time it takes for him or her to suffer a burn without sunscreen."[26] Thus, if a person develops a sunburn in 10 minutes when not wearing a sunscreen, the same person will prevent sunburn for 150 minutes if he/she wears a sunscreen with an SPF of 15.[27] It is important to note that sunscreens with higher SPF do not last or remain effective on the skin any longer than lower SPF and must be continually reapplied as directed, usually every two hours.[28]

The SPF is an imperfect measure of skin damage because invisible damage and skin aging are also caused by ultraviolet type A (UVA, wavelength 315–400 or 320–400 nm), which does not primarily cause reddening or pain. Conventional sunscreen blocks very little UVA radiation relative to the nominal SPF; broad-spectrum sunscreens are designed to protect against both UVB and UVA.[29][30][31] According to a 2004 study, UVA also causes DNA damage to cells deep within the skin, increasing the risk of malignant melanomas.[32] Even some products labeled "broad-spectrum UVA/UVB protection" do not provide good protection against UVA rays.[33] Titanium dioxide probably gives good protection, but does not completely cover the UVA spectrum, as early 2000s research suggests that zinc oxide is superior to titanium dioxide at wavelengths between 340 and 380 nm.[34]

Owing to consumer confusion over the real degree and duration of protection offered, labeling restrictions are in force in several countries. In the EU, sunscreen labels can only go up to SPF 50+ (initially listed as 30 but soon revised to 50).[35] Australia's Therapeutic Goods Administration increased the upper limit to 50+ in 2012.[36][37] In the 2007 and 2011 draft rules, the Food and Drug Administration (FDA) proposed a maximum SPF label of 50, to limit unrealistic claims.[38][39][40] Others have proposed restricting the active ingredients to an SPF of no more than 50, due to lack of evidence that higher dosages provide more meaningful protection.[41]

UV sunlight spectrum (on a summer day in the Netherlands), along with the CIE Erythemal action spectrum. The effective spectrum is the product of the former two.

The SPF can be measured by applying sunscreen to the skin of a volunteer and measuring how long it takes before sunburn occurs when exposed to an artificial sunlight source. In the US, such an in vivo test is required by the FDA. It can also be measured in vitro with the help of a specially designed spectrometer. In this case, the actual transmittance of the sunscreen is measured, along with the degradation of the product due to being exposed to sunlight. In this case, the transmittance of the sunscreen must be measured over all wavelengths in the UVB–UVA range (290–400 nm), along with a table of how effective various wavelengths are in causing sunburn (the erythemal action spectrum) and the actual intensity spectrum of sunlight (see the figure). Such in vitro measurements agree very well with in vivo measurements.[42] Numerous methods have been devised for evaluation of UVA and UVB protection. The most-reliable spectrophotochemical methods eliminate the subjective nature of grading erythema.[43]

The ultraviolet protection factor (UPF) is a similar scale developed for rating fabrics for sun protective clothing.

Mathematically, the SPF (or the UPF) is calculated from measured data as

where is the solar irradiance spectrum, the erythemal action spectrum, and the monochromatic protection factor, all functions of the wavelength . The MPF is roughly the inverse of the transmittance at a given wavelength.

The above means that the SPF is not simply the inverse of the transmittance in the UVB region. If that were true, then applying two layers of SPF 5 sunscreen would be equivalent to SPF 25 (5 times 5). The actual combined SPF is always lower than the square of the single-layer SPF.

UVA protection

Persistent pigment darkening (PPD)

The persistent pigment darkening (PPD) method is a method of measuring UVA protection, similar to the SPF method of measuring sunburn protection. Originally developed in Japan, it is the preferred method used by manufacturers such as L'Oréal.

Instead of measuring erythema or reddening of the skin, the PPD method uses UVA radiation to cause a persistent darkening or tanning of the skin. Theoretically, a sunscreen with a PPD rating of 10 should allow a person 10 times as much UVA exposure as would be without protection. The PPD method is an in vivo test like SPF. In addition, Colipa has introduced a method that, it is claimed, can measure this in vitro and provide parity with the PPD method.[44]

SPF equivalence

The UVA seal used in the EU

As part of revised guidelines for sunscreens in the EU, there is a requirement to provide the consumer with a minimum level of UVA protection in relation to the SPF. This should be a UVA PF of at least 1/3 of the SPF to carry the UVA seal. The implementation of this seal is in its phase-in period,[when?] so a sunscreen without it may already offer this protection.[45]

A set of final U.S. FDA rules effective from summer 2012 defines the phrase "broad spectrum" as providing UVA protection proportional to the UVB protection.[39]

Star rating system

In the UK and Ireland, the Boots star rating system is a proprietary in vitro method used to describe the ratio of UVA to UVB protection offered by sunscreen creams and sprays. Based on original work by Prof. Brian Diffey at Newcastle University, the Boots Company in Nottingham, UK, developed a standard method that has been adopted by most companies marketing these products in the UK. The logo and methodology of the test are licensed for a token fee to any manufacturer or brand of sunscreens that are sold in the Boots retail chain, provided the products to which the logo is applied perform to the standard claimed. Own Label products exclusively sold in other retailers are now excluded from the terms of the license.

One-star products provide the least ratio of UVA protection; five-star products are best. The method has recently been revised in the light of the Colipa UVA PF test, and with the new EU recommendations regarding UVA PF. The method still uses a spectrophotometer to measure absorption of UVA versus UVB; the difference stems from a requirement to pre-irradiate samples (where this was not previously required) to give a better indication of UVA protection, and of photostability when the product is used. With the current methodology, the lowest rating is three stars, the highest being five stars.

In August 2007, the FDA put out for consultation the proposal that a version of this protocol be used to inform users of American product of the protection that it gives against UVA,[38] but after concern this would be too confusing this was not adopted.[41]

PA system

Asian brands, particularly Japanese ones, tend to use The Protection Grade of UVA (PA) system to measure the UVA protection a sunscreen provides. The PA system is based on the PPD reaction and is now widely adopted on the labels of sunscreens. According to the Japan Cosmetic Industry Association, PA+ corresponds to a UVA protection factor between two and four, PA++ between four and eight, and PA+++ more than eight.

Sunblock

A tube of SPF 15 sun lotion

Sunblock typically refers to opaque sunscreen that is effective at blocking both UVA and UVB rays and uses a heavy carrier oil to resist being washed off. Titanium dioxide and zinc oxide are two of the important ingredients in sunblock.[46] Unlike the organic sun-blocking agents used in many sunscreens, these metal oxides do not degrade with exposure to sunlight.

The use of the word "sunblock" in the marketing of sunscreens is controversial. Since 2013, the FDA has banned such use because it can lead consumers to overestimate the effectiveness of products so labeled.[39] Nonetheless, many consumers use the words sunblock and sunscreen synonymously.

For total protection against damage from the sun, the skin needs to be protected from UVA, UVB and IRA (infrared light). Roughly 35% of solar energy is IRA.[47]

Active ingredients

Sunscreens contain one or more of the following ingredients:

  • Organic chemical compounds that absorb ultraviolet light.
  • Inorganic particulates that reflect, scatter, and absorb UV light (such as titanium dioxide, zinc oxide, or a combination of both).[46]
  • Organic particulates that mostly absorb light like organic chemical compounds, but contain multiple chromophores that may reflect and scatter a fraction of light like inorganic particulates, and behave differently in formulations than organic chemical compounds. An example is Tinosorb M. Since the UV-attenuating efficacy depends strongly on particle size, the material is micronised to particle sizes below 200 nm. The mode of action of this photostable filter system is governed to about 90% by absorption and 10% by scattering of UV light.

The principal ingredients in sunscreens are usually aromatic molecules conjugated with carbonyl groups. This general structure allows the molecule to absorb high-energy ultraviolet rays and release the energy as lower-energy rays, thereby preventing the skin-damaging ultraviolet rays from reaching the skin. So, upon exposure to UV light, most of the ingredients (with the notable exception of avobenzone) do not undergo significant chemical change, allowing these ingredients to retain the UV-absorbing potency without significant photodegradation.[48] A chemical stabilizer is included in some sunscreens containing avobenzone to slow its breakdown; examples include formulations containing Helioplex[49] and AvoTriplex.[50] The stability of avobenzone can also be improved by bemotrizinol,[51] octocrylene[52] and various other photostabilisers. Most organic compounds in sunscreens slowly degrade and become less effective over the course of several years if stored properly, resulting in the expiration dates calculated for the product.[53]

Sunscreening agents are used in some hair care products such as shampoos, conditioners and styling agents to protect against protein degradation and color loss. Currently, benzophenone-4 and ethylhexyl methoxycinnamate are the two sunscreens most commonly used in hair products. Cinnamidopyltrimonium chloride and a few others are used to a much less degree. The common sunscreens used on skin are rarely used for hair products due to their texture and weight effects.

The following are the FDA allowable active ingredients in sunscreens:

UV-filter Other names Maximum concentration Permitted in these countries Results of safety testing
p-Aminobenzoic acid PABA 15% (EU: banned from sale to consumers from 8 October 2009) USA, AUS Protects against skin tumors in mice.[54][55][56] Shown to increase DNA defects, however, and is now less commonly used.
Padimate O OD-PABA, octyldimethyl-PABA, σ-PABA 8% (EU, USA, AUS) 10% (JP)

(Not currently supported in EU and may be delisted)

EU, USA, AUS, JP
Phenylbenzimidazole sulfonic acid Ensulizole, Eusolex 232, PBSA, Parsol HS 4% (US, AUS) 8% (EU) 3% (JP) EU, USA, AUS, JP Genotoxic in bacteria[57]
Cinoxate 2-Ethoxyethyl p-methoxycinnamate 3% (US) 6% (AUS) USA, AUS
Dioxybenzone Benzophenone-8 3% USA, AUS
Oxybenzone Benzophenone-3, Eusolex 4360, Escalol 567 6% (US) 10% (AUS, EU) 5% (JP) EU, USA, AUS, JP
Homosalate Homomethyl salicylate, HMS 10% (EU, JP) 15% (US, AUS) EU, USA, AUS, JP
Menthyl anthranilate Meradimate 5% USA, AUS
Octocrylene Eusolex OCR, 2-Cyano-3,3-diphenyl acrylic acid, 2-ethylhexylester 10% EU, USA, AUS, JP Increases ROS[58]
Octyl methoxycinnamate Octinoxate, EMC, OMC, Ethylhexyl methoxycinnamate, Escalol 557, 2-Ethylhexyl-paramethoxycinnamate, Parsol MCX 7.5% (US) 10% (EU, AUS) 20% (JP) EU, USA, AUS, JP
Octyl salicylate Octisalate, 2-Ethylhexyl salicylate, Escalol 587, 5% (EU, USA, AUS) 10% (JP) EU, USA, AUS, JP
Sulisobenzone 2-Hydroxy-4-Methoxybenzophenone-5-sulfonic acid, 3-Benzoyl-4-hydroxy-6-methoxybenzenesulfonic acid, Benzophenone-4, Escalol 577 5% (EU) 10% (US, AUS, JP) EU, USA, AUS, JP
Trolamine salicylate Triethanolamine salicylate 12% USA, AUS
Avobenzone 1-(4-methoxyphenyl)-3-(4-tert-butyl
phenyl)propane-1,3-dione, Butyl methoxy dibenzoylmethane, BMDBM, Parsol 1789, Eusolex 9020
3% (US) 5% (EU, AUS)10% (JP) EU, USA, AUS, JP Not available[59]
Ecamsule Mexoryl SX, Terephthalylidene Dicamphor Sulfonic Acid 10% EU, AUS (US: approved in certain formulations up to 3% via New Drug Application (NDA) Route) Protects against skin tumors in mice[60][61][62]
Titanium dioxide CI77891 25% (No limit Japan) EU, USA, AUS, JP
Zinc oxide 25% (US) 20% (AUS)

(EU: 25%, provided particle size >100 nm) (Japan: no limit)

EU, USA, AUS, JP Protects against skin tumors in mice[60]

Other ingredients approved within the EU[63] and other parts of the world,[64] that have not been included in the current FDA Monograph:

UV-filter Other names Maximum concentration Permitted in
4-Methylbenzylidene camphor Enzacamene, Parsol 5000, Eusolex 6300, MBC 4%* EU, AUS
Tinosorb M Bisoctrizole, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol, MBBT 10%* EU, AUS, JP
Tinosorb S Bis-ethylhexyloxyphenol methoxyphenol triazine, Bemotrizinol, BEMT, anisotriazine 10% (EU, AUS) 3% (JP)* EU, AUS, JP
Neo Heliopan AP Bisdisulizole Disodium, Disodium phenyl dibenzimidazole tetrasulfonate, bisimidazylate, DPDT 10% EU, AUS
Mexoryl XL Drometrizole Trisiloxane 15% EU, AUS
Benzophenone-9 Uvinul DS 49, CAS 3121-60-6, Sodium Dihydroxy Dimethoxy Disulfobenzophenone [65] 10% JP
Uvinul T 150 Octyl triazone, ethylhexyl triazone, EHT 5% (EU, AUS) 3% (JP)* EU, AUS
Uvinul A Plus Diethylamino Hydroxybenzoyl Hexyl Benzoate 10% (EU,JP) EU, JP
Uvasorb HEB Iscotrizinol, Diethylhexyl butamido triazone, DBT 10% (EU) 5% (JP)* EU, JP
Parsol SLX Dimethico-diethylbenzalmalonate, Polysilicone-15 10% EU, AUS, JP
Amiloxate Isopentyl-4-methoxycinnamate, Isoamyl p-Methoxycinnamate, IMC, Neo Heliopan E1000 10%* EU, AUS

* Time and Extent Application (TEA), Proposed Rule on FDA approval expected 2009

Many of the ingredients awaiting approval by the FDA were relatively new, and developed to absorb UVA.[66] In 2014, the U.S. Congress introduced the Sunscreen Innovation Act, with the goal of accelerating the FDA approval process.[67][68]

Application

A sunscreen study from 2001 suggests that the best protection is achieved by dividing the SPF number in half and reapplying that many minutes after sun exposure begins. For example, if the SPF is 30, sunscreen should be reapplied once after 15 minutes of exposure. Further reapplication is only necessary after activities such as swimming, sweating, or rubbing/wiping.[69]

More-recent research at the University of California, Riverside, indicates that sunscreen must be reapplied within 2 hours in order to remain effective. Not reapplying could even cause more cell damage than not using sunscreen at all, due to the release of extra free radicals from those sunscreen chemicals that were absorbed into the skin.[58]

Dosage

The dose used in FDA sunscreen testing is 2 mg/cm2 of exposed skin.[48] If one assumes an "average" adult build of height 5 ft 4 in (163 cm) and weight 150 lb (68 kg) with a 32-inch (82-cm) waist, that adult wearing a bathing suit covering the groin area should apply 29 g (approximately 1 oz) evenly to the uncovered body area. Considering only the face, this translates to about 1/4 to 1/3 of a teaspoon for the average adult face. Larger or smaller individuals should scale these quantities accordingly.

Some studies have shown that people commonly apply only 1/2 to 1/4 of the amount recommended for achieving the rated sun protection factor (SPF), and in consequence the effective SPF should be downgraded to a square root or 4th root of the advertised value.[70] A later study found a significant exponential relation between SPF and the amount of sunscreen applied, and the results are closer to linearity than expected by theory.[71]

Other FDA labeling regulations

Sunscreen labeling standards have been evolving in the United States since the FDA first adopted the SPF calculation in 1978.[72] The FDA issued a comprehensive set of rules in June 2011, taking effect in 2012–2013, designed to help consumers identify and select suitable sunscreen products offering protection from sunburn, early skin aging, and skin cancer:[39][73][74][75]

  • To be classified as "broad spectrum", sunscreen products must provide protection against both UVA and UVB, with specific tests required for both.
  • Claims of products being "waterproof" or "sweatproof" are prohibited, while "sunblock" and "instant protection" and "protection for more than 2 hours" are all prohibited without specific FDA approval.
  • "Water resistance" claims on the front label must indicate how long the sunscreen remains effective and specify whether this applies to swimming or sweating, based on standard testing.
  • Sunscreens must include standardized "Drug Facts" information on the container. However, there is no regulation that deems it necessary to mention whether the contents contain nanoparticles of mineral ingredients. (The EU has stricter regulation against the use of nanoparticles, and in 2009 introduced labeling requirements for nanoparticle ingredients in certain sunscreens and cosmetics.)[76][77]
  • The maximum SPF value on sunscreen labels is "50+".

See also

Notes

  1. ^ "Preventing melanoma". Cancer Research UK. Retrieved 2009-09-22.
  2. ^ Sunscreens | The Ageing Skin
  3. ^ What You Need To Know About Skin Cancer
  4. ^ Terence SC Poon, Ross StC Barnetson and Gary M Halliday (2003). "Prevention of Immunosuppression by Sunscreens in Humans Is Unrelated to Protection from Erythema and Dependent on Protection from Ultraviolet A in the Face of Constant Ultraviolet B Protection". J Invest Dermatol. 121: 184–90. doi:10.1046/j.1523-1747.2003.12317.x.
  5. ^ a b "Sunscreen and Prevention of Skin Aging". 158 (11). Annals of Internal Medicine. June 4, 2013: 781–790. {{cite journal}}: Cite journal requires |journal= (help); Cite uses deprecated parameter |authors= (help)
  6. ^ Kanavy HE, Gerstenblith MR (December 2011). "Ultraviolet radiation and melanoma". Semin Cutan Med Surg. 30 (4): 222–8. doi:10.1016/j.sder.2011.08.003. PMID 22123420.
  7. ^ a b Burnett M.E., Wang S.Q. (April 2011). "Current sunscreen controversies: a critical review". Photodermatology, Photoimmunology & Photomedicine. 27 (2): 58–67. doi:10.1111/j.1600-0781.2011.00557.x. PMID 21392107.
  8. ^ Kütting B, Drexler H (December 2010). "UV-induced skin cancer at workplace and evidence-based prevention". Int Arch Occup Environ Health. 83 (8): 843–54. doi:10.1007/s00420-010-0532-4. PMID 20414668.
  9. ^ Dresbach S.H., Brown W. (2008). "Ultraviolet Radiation" (PDF). Ohioline Fact Sheet Series. Ohio State University Extension.
  10. ^ "CDC: Americans Carry Body Burden of Toxic Sunscreen Chemical". Environmental Working Group. March 25, 2008. Retrieved July 23, 2014.
  11. ^ "Safety of sunscreens containing nanoparticles of zinc oxide or titanium dioxide". February 2006. Retrieved 16 April 2014.
  12. ^ Norval, M; Wulf, HC (October 2009). "Does chronic sunscreen use reduce vitamin D production to insufficient levels?". The British journal of dermatology. 161 (4): 732–6. doi:10.1111/j.1365-2133.2009.09332.x. PMID 19663879.
  13. ^ Professor Young (2013-06-04). "Worried suncream blocks vitamin D? Here's good news..." Boots. Daily Mail. Retrieved 2013-07-05.
  14. ^ "Dietary Reference Intakes for Calcium and Vitamin D". National Academies Press. 2011. Retrieved July 23, 2014.
  15. ^ "Dietary Supplement Fact Sheet: Vitamin D". National Institutes of Health. Archived from the original on 2007-09-10. Retrieved 2007-09-10.
  16. ^ a b c Shaath, Nadim A., editor (2005). Sunscreens: Regulations and Commercial Development, Third Edition. Taylor & Francis Group. {{cite book}}: |first= has generic name (help)CS1 maint: multiple names: authors list (link)
  17. ^ Craddock, P.T. (1998). 2000 Years of Zinc and Brass. British Museum. p. 27. ISBN 0-86159-124-0.
  18. ^ Craddock, P.T. (2008). "Mining and Metallurgy, chapter 4". In Oleson, John Peter (ed.). The Oxford Handbook of Engineering and Technology in the Classical World. Oxford University Press. pp. 111–112. ISBN 0-19-518731-8.
  19. ^ a b c Rigel, Darrell S. (2004). Photoaging. Hoboken: Informa Healthcare. pp. 73–74. ISBN 9780824752095.
  20. ^ Wang, Steven Q; Hu, Judy Y. "Challenges in Making an Effective Sunscreen". The Skin Cancer Foundation. Retrieved 2014-06-12.
  21. ^ a b c Lim, Henry W. "Quantum Leaps: New, Improved Sunscreens Have Arrived". The Skin Cancer Foundation. Retrieved July 23, 2014.
  22. ^ MacEachern, W.N.; Jillson, O.F. (January 1964). "A Practical Sunscreen — "Red Vet Pet"". Arch Dermatol. 89 (1): 147–150. Retrieved July 24, 2014.
  23. ^ "Sunscreen: A History". The New York Times. June 23, 2010. Retrieved July 24, 2014.
  24. ^ "Gletscher Crème". 2010-04-22. Piz Buin. Archived from the original on 2010-05-12. Retrieved 2013-06-29.
  25. ^ Lim, Henry W., editor; et al. (2007). Photodermatology. CRC Press. p. 6. ISBN 9781420019964. Retrieved July 24, 2014. {{cite book}}: |first1= has generic name (help); Explicit use of et al. in: |last2= (help)CS1 maint: multiple names: authors list (link)
  26. ^ Sunblock. UCSF. School of Medicine. Dept of Dermatology.
  27. ^ Sunblock. UCSF. School of Medicine. Dept of Dermatology.
  28. ^ "Sunscreen FAQs". American Academy of Dermatology. Retrieved July 22, 2014.
  29. ^ Attention: This template ({{cite pmid}}) is deprecated. To cite the publication identified by PMID 12118426, please use {{cite journal}} with |pmid= 12118426 instead.
  30. ^ Attention: This template ({{cite doi}}) is deprecated. To cite the publication identified by doi: 10.1046/j.1523-1747.2003.12498.x, please use {{cite journal}} (if it was published in a bona fide academic journal, otherwise {{cite report}} with |doi= 10.1046/j.1523-1747.2003.12498.x instead.
  31. ^ Attention: This template ({{cite doi}}) is deprecated. To cite the publication identified by doi: 10.1016/j.jaad.2007.04.035, please use {{cite journal}} (if it was published in a bona fide academic journal, otherwise {{cite report}} with |doi= 10.1016/j.jaad.2007.04.035 instead.
  32. ^ Berneburg M, Plettenberg H, Medve-König K, Pfahlberg A, Gers-Barlag H, Gefeller O, Krutmann J (2004). "Induction of the photoaging-associated mitochondrial common deletion in vivo in normal human skin". J Invest Dermatol. 122 (5): 1277–83. doi:10.1111/j.0022-202X.2004.22502.x. PMID 15140232.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  33. ^ MSNBC.com : Sunscreen — protection or 'snake oil?'
  34. ^ Pinnell SR, Fairhurst D, Gillies R, Mitchnick MA, Kollias N (April 2000). "Microfine zinc oxide is a superior sunscreen ingredient to microfine titanium dioxide". Dermatol Surg. 26 (4): 309–14. doi:10.1046/j.1524-4725.2000.99237.x. PMID 10759815.{{cite journal}}: CS1 maint: multiple names: authors list (link) [dead link]
  35. ^ "Commission Recommendation of 22 September 2006 on the efficacy of sunscreen products and the claims made relating thereto". Official Journal of the European Union. 2006-09-22. Retrieved 2009-09-25. {{cite journal}}: Cite journal requires |journal= (help)
  36. ^ "UV Resource Guide - Sunscreens". Arpansa. 2008-12-20. Retrieved 2009-09-25.
  37. ^ "SPF50+ Sunscreen". 2013-02-01. Retrieved 2014-02-06.
  38. ^ a b Questions and Answers on the 2007 Sunscreen Proposed Rule
  39. ^ a b c d "Questions and Answers: FDA announces new requirements for over-the-counter (OTC) sunscreen products marketed in the U.S." 2011-06-23. Retrieved 2012-04-10.
  40. ^ Department of Health and Human Services: Food and Drug Administration (17 June 2011). "Revised Effectiveness Determination; Sunscreen Drug Products for Over-the-Counter Human Use" (PDF). Federal Register. 76 (117): 35672–35678. Retrieved 21 November 2013.
  41. ^ a b "Sunscreen Takes Some Heat: New Dangers, New Rules". 2011-06-16. Retrieved 2012-04-10.
  42. ^ Optometrics products
  43. ^ Dominique Moyal "How to measure UVA protection afforded by suncreen products" www.medscape.com/viewarticle/576849
  44. ^ Colipa UVA method[dead link]
  45. ^ www.colipa.com[dead link]
  46. ^ a b "Nanotechnology Information Center: Properties, Applications, Research, and Safety Guidelines". American Elements.
  47. ^ P. Schroeder, PhD and J. Krutmann, MD What is Needed for a Sunscreen to Provide Complete Protection
  48. ^ a b "Re: Tentative Final Monograph for OTC Sunscreen" (PDF). Food and Drug Administration (United States). 1998-09-11. Retrieved 2009-09-25.
  49. ^ Neutrogena | How Helioplex Works
  50. ^ Banana Boat AvoTriplex
  51. ^ Chatelain E, Gabard B. (September 2001). "Photostabilization of Butyl methoxydibenzoylmethane (Avobenzone) and Ethylhexyl methoxycinnamate by Bis-ethylhexyloxyphenol methoxyphenyl triazine (Tinosorb S), a new UV broadband filter". Photochem Photobiol. 74 (3): 401–6. doi:10.1562/0031-8655(2001)074<0401:POBMAA>2.0.CO;2. PMID 11594052.
  52. ^ DSM Nutritional Products North America - Cosmetics: Basis for Performance - Parsol 340 - Octocrylene
  53. ^ Burke, Karen E. "Does sunscreen become ineffective with age?". The Skin Cancer Foundation. Retrieved July 31, 2014.
  54. ^ "The inhibiting effect of PABA on photocarcinogenesis". Archives of Dermatological Research. 282 (1): 38–41. 1990. doi:10.1007/BF00505643. PMID 2317082. {{cite journal}}: Cite uses deprecated parameter |authors= (help)
  55. ^ "The effect of short-term application of PABA on photocarcinogenesis". Acta Derm Venerol. 70 (1): 72–75. 1990. PMID 1967881. {{cite journal}}: Cite uses deprecated parameter |authors= (help)
  56. ^ "The sensitization of near-ultraviolet radiation killing of mammalian cells by the sunscreen agent para-aminobenzoic acid". Journal of Investigative Dermatology. 79 (6): 354–357. 1982. doi:10.1111/1523-1747.ep12529409. PMID 6982950. {{cite journal}}: Cite uses deprecated parameter |authors= (help)
  57. ^ Mosley, C N; Wang, L; Gilley, S; Wang, S; Yu, H (2007). "Light-Induced Cytotoxicity and Genotoxicity of a Sunscreen Agent, 2-Phenylbenzimidazol in Salmonella typhimurium TA 102 and HaCaT Keratinocytes". International Journal of Environmental Research and Public Health. 4 (2): 126–131. doi:10.3390/ijerph2007040006. PMID 17617675. {{cite journal}}: Cite has empty unknown parameter: |month= (help)CS1 maint: unflagged free DOI (link)
  58. ^ a b Kerry M. Hanson, Enrico Gratton and Christopher J. Bardeen (2006). "Sunscreen enhancement of UV-induced reactive oxygen species in the skin". Free Radical Biology and Medicine. 41 (8): 1205–12. doi:10.1016/j.freeradbiomed.2006.06.011. PMID 17015167.
  59. ^ Nash, JF (2006). "Human Safety and Efficacy of Ultraviolet Filters and Sunscreen Products". Dermatologic Clinics. 24 (1): 35–51. doi:10.1016/j.det.2005.09.006. PMID 16311166.
  60. ^ a b Lautenschlager, Stephan; Wulf, Hans Christian; Pittelkow, Mark R (2007). "photoprotection". Lancet. 370 (9586): 528–37. doi:10.1016/S0140-6736(07)60638-2. PMID 17693182.
  61. ^ Benech-Kieffer F, Meuling WJ, Leclerc C, Roza L, Leclaire J, Nohynek G (Nov–Dec 2003). "Percutaneous absorption of Mexoryl SX in human volunteers: comparison with in vitro data". Skin Pharmacol Appl Skin Physiol. 16 (6): 343–55. doi:10.1159/000072929. PMID 14528058.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  62. ^ Fourtanier A (October 1996). "Mexoryl SX protects against solar-simulated UVR-induced photocarcinogenesis in mice". Photochem Photobiol. 64 (4): 688–93. doi:10.1111/j.1751-1097.1996.tb03125.x. PMID 8863475.
  63. ^ "Regulation No. 1223/2009 on cosmetic products". Official Journal of the European Union. December 22, 2009. Retrieved July 23, 2014.
  64. ^ Australian Regulatory Guidelines for OTC Medicines - Chapter 10
  65. ^ "Uvinul Grades" (PDF). Retrieved 2009-09-25.
  66. ^ Kapes, Beth (July 2005). "Docs rally for better sun protection — Advances still unavailable in United States". Dermatology Times. 26 (7): 100. Retrieved July 23, 2014.
  67. ^ "H.R.4250 — Sunscreen Innovation Act". Library of Congress. Retrieved August 1, 2014.
  68. ^ Sifferlin, Alexandra (July 16, 2014). "We're One Step Closer to Better Sunscreen". Time Magazine. Retrieved August 1, 2014.
  69. ^ Diffey B (2001). "When should sunscreen be reapplied?". J Am Acad Dermatol. 45 (6): 882–5. doi:10.1067/mjd.2001.117385. PMID 11712033.
  70. ^ Faurschou A, Wulf HC (April 2007). "The relation between sun protection factor and amount of sunscreen applied in vivo". Br. J. Dermatol. 156 (4): 716–9. doi:10.1111/j.1365-2133.2006.07684.x. PMID 17493070.
  71. ^ Schalka S, dos Reis VM, Cucé LC (August 2009). "The influence of the amount of sunscreen applied and its sun protection factor (SPF): evaluation of two sunscreens including the same ingredients at different concentrations". Photodermatol Photoimmunol Photomed. 25 (4): 175–80. doi:10.1111/j.1600-0781.2009.00408.x. PMID 19614894.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  72. ^ Department of Health and Human Services: Food and Drug Administration (August 25, 1978). "Sunscreen Drug Products for Over-the-Counter Human Use" (PDF). Federal Register. 43 (166): 38206–38269. Retrieved July 30, 2014.
  73. ^ Department of Health and Human Services: Food and Drug Administration (June 17, 2011). "Sunscreen Drug Products for Over-the-Counter Human Use; Final Rules and Proposed Rules" (PDF). Federal Register. 76 (117): 35620–35665. Retrieved August 19, 2014.
  74. ^ Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Delay of Compliance Dates Retrieved 09/27/2012
  75. ^ US FDA Delays Implementation Deadlines for Sunscreen Labeling Requirements SGS SafeGuards Bulletin, Retrieved 09/27/2012
  76. ^ "Is Sunscreen Safe?". Eluxe Magazine. June 8, 2014. Retrieved June 10, 2014. {{cite magazine}}: Cite magazine requires |magazine= (help)
  77. ^ New sunscreen labeling rules announced by U.S. FDA SGS SafeGuards Bulletin, Retrieved 06/20/2013