Multi-laboratory validation of very high sun protection factor values
Background: High sun protection factor (SPF) sunscreens have multiple benefits but there has not been validation of the test method for determining SPF values higher than 50. This study addresses specifically the accuracy and reproducibility of the high SPF test. Methods: Two high SPF formulations w...
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Veröffentlicht in: | Photodermatology, photoimmunology & photomedicine photoimmunology & photomedicine, 2011-02, Vol.27 (1), p.30-34 |
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creator | Stanfield, Joseph W. Ou-Yang, Hao Chen, Theresa Cole, Curtis Appa, Yohini |
description | Background: High sun protection factor (SPF) sunscreens have multiple benefits but there has not been validation of the test method for determining SPF values higher than 50. This study addresses specifically the accuracy and reproducibility of the high SPF test.
Methods: Two high SPF formulations with a standard reference (SPF 15) were tested at four independent test facilities according to the 2007 FDA proposed amendments to the sunscreen monograph. Statistical analysis was performed to compare the SPF results within each lab as well as the SPF results between different labs.
Results: The test formulations have overall mean values of 90.5 and 70.7. There was no statistically significant difference between the labs for either formulation and all four labs were able to statistically differentiate these two levels of SPF values. The coefficients of variance (CV) for the high SPF formulations were comparable to those of the corresponding SPF 15 reference within each lab.
Conclusions: The data show that SPF values above 50 and up to at least 90 can be measured by multiple laboratories with accuracy and reproducibility. |
doi_str_mv | 10.1111/j.1600-0781.2010.00561.x |
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Methods: Two high SPF formulations with a standard reference (SPF 15) were tested at four independent test facilities according to the 2007 FDA proposed amendments to the sunscreen monograph. Statistical analysis was performed to compare the SPF results within each lab as well as the SPF results between different labs.
Results: The test formulations have overall mean values of 90.5 and 70.7. There was no statistically significant difference between the labs for either formulation and all four labs were able to statistically differentiate these two levels of SPF values. The coefficients of variance (CV) for the high SPF formulations were comparable to those of the corresponding SPF 15 reference within each lab.
Conclusions: The data show that SPF values above 50 and up to at least 90 can be measured by multiple laboratories with accuracy and reproducibility.</description><identifier>ISSN: 0905-4383</identifier><identifier>EISSN: 1600-0781</identifier><identifier>DOI: 10.1111/j.1600-0781.2010.00561.x</identifier><identifier>PMID: 21198880</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adult ; Aged ; Biological and medical sciences ; coefficient of variance ; Dermatology ; Diseases of the skin. Cosmetics ; FDA monograph ; Female ; Humans ; Laboratories - standards ; Male ; Medical sciences ; Middle Aged ; Radiation Protection - standards ; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) ; Reproducibility of Results ; SPF test ; statistical analysis ; Sunburn - prevention & control ; sunscreen ; Sunscreening Agents - chemistry ; Young Adult</subject><ispartof>Photodermatology, photoimmunology & photomedicine, 2011-02, Vol.27 (1), p.30-34</ispartof><rights>2011 John Wiley & Sons A/S</rights><rights>2015 INIST-CNRS</rights><rights>2011 John Wiley & Sons A/S.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4361-ed71bf55f9deea678869d1db05e305023a07f0a96b3cc9b5432f0037affc0b073</citedby><cites>FETCH-LOGICAL-c4361-ed71bf55f9deea678869d1db05e305023a07f0a96b3cc9b5432f0037affc0b073</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1600-0781.2010.00561.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1600-0781.2010.00561.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27903,27904,45553,45554</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23739888$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21198880$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Stanfield, Joseph W.</creatorcontrib><creatorcontrib>Ou-Yang, Hao</creatorcontrib><creatorcontrib>Chen, Theresa</creatorcontrib><creatorcontrib>Cole, Curtis</creatorcontrib><creatorcontrib>Appa, Yohini</creatorcontrib><title>Multi-laboratory validation of very high sun protection factor values</title><title>Photodermatology, photoimmunology & photomedicine</title><addtitle>Photodermatol Photoimmunol Photomed</addtitle><description>Background: High sun protection factor (SPF) sunscreens have multiple benefits but there has not been validation of the test method for determining SPF values higher than 50. This study addresses specifically the accuracy and reproducibility of the high SPF test.
Methods: Two high SPF formulations with a standard reference (SPF 15) were tested at four independent test facilities according to the 2007 FDA proposed amendments to the sunscreen monograph. Statistical analysis was performed to compare the SPF results within each lab as well as the SPF results between different labs.
Results: The test formulations have overall mean values of 90.5 and 70.7. There was no statistically significant difference between the labs for either formulation and all four labs were able to statistically differentiate these two levels of SPF values. The coefficients of variance (CV) for the high SPF formulations were comparable to those of the corresponding SPF 15 reference within each lab.
Conclusions: The data show that SPF values above 50 and up to at least 90 can be measured by multiple laboratories with accuracy and reproducibility.</description><subject>Adult</subject><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>coefficient of variance</subject><subject>Dermatology</subject><subject>Diseases of the skin. Cosmetics</subject><subject>FDA monograph</subject><subject>Female</subject><subject>Humans</subject><subject>Laboratories - standards</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Radiation Protection - standards</subject><subject>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</subject><subject>Reproducibility of Results</subject><subject>SPF test</subject><subject>statistical analysis</subject><subject>Sunburn - prevention & control</subject><subject>sunscreen</subject><subject>Sunscreening Agents - chemistry</subject><subject>Young Adult</subject><issn>0905-4383</issn><issn>1600-0781</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkMlOwzAQhi0EgrK8AsoFcUoZx3HsHDigshSVpQeWo-U4NrikDdgJtG-PQ0u54outme_3jD6EIgx9HM7JpI8zgBgYx_0EQhWAZrg_30C9dWMT9SAHGqeEkx206_0EANIU8DbaSTDOOefQQxe3bdXYuJJF7WRTu0X0KStbysbWs6g20acOpVf78hr5dha9u7rR6qdnpAp4R7fa76MtIyuvD1b3Hnq8vHgYDOOb-6vrwdlNrFKS4ViXDBeGUpOXWsuMcZ7lJS4LoJoAhYRIYAZknhVEqbygKUkMAGHSGAUFMLKHjpf_hkU-wtxGTK1XuqrkTNetFzxJKM1ynASSL0nlau-dNuLd2al0C4FBdA7FRHSqRKdKdA7Fj0MxD9HD1ZC2mOpyHfyVFoCjFSC9kpVxcqas_-MIIx0YuNMl92Urvfj3AmI8HI_DK-TjZd76Rs_XeeneRMYIo-L57ko846fzwSgZhbHfUyib7Q</recordid><startdate>201102</startdate><enddate>201102</enddate><creator>Stanfield, Joseph W.</creator><creator>Ou-Yang, Hao</creator><creator>Chen, Theresa</creator><creator>Cole, Curtis</creator><creator>Appa, Yohini</creator><general>Blackwell Publishing Ltd</general><general>Blackwell</general><scope>BSCLL</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>201102</creationdate><title>Multi-laboratory validation of very high sun protection factor values</title><author>Stanfield, Joseph W. ; Ou-Yang, Hao ; Chen, Theresa ; Cole, Curtis ; Appa, Yohini</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4361-ed71bf55f9deea678869d1db05e305023a07f0a96b3cc9b5432f0037affc0b073</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Biological and medical sciences</topic><topic>coefficient of variance</topic><topic>Dermatology</topic><topic>Diseases of the skin. Cosmetics</topic><topic>FDA monograph</topic><topic>Female</topic><topic>Humans</topic><topic>Laboratories - standards</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Radiation Protection - standards</topic><topic>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</topic><topic>Reproducibility of Results</topic><topic>SPF test</topic><topic>statistical analysis</topic><topic>Sunburn - prevention & control</topic><topic>sunscreen</topic><topic>Sunscreening Agents - chemistry</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Stanfield, Joseph W.</creatorcontrib><creatorcontrib>Ou-Yang, Hao</creatorcontrib><creatorcontrib>Chen, Theresa</creatorcontrib><creatorcontrib>Cole, Curtis</creatorcontrib><creatorcontrib>Appa, Yohini</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Photodermatology, photoimmunology & photomedicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Stanfield, Joseph W.</au><au>Ou-Yang, Hao</au><au>Chen, Theresa</au><au>Cole, Curtis</au><au>Appa, Yohini</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Multi-laboratory validation of very high sun protection factor values</atitle><jtitle>Photodermatology, photoimmunology & photomedicine</jtitle><addtitle>Photodermatol Photoimmunol Photomed</addtitle><date>2011-02</date><risdate>2011</risdate><volume>27</volume><issue>1</issue><spage>30</spage><epage>34</epage><pages>30-34</pages><issn>0905-4383</issn><eissn>1600-0781</eissn><abstract>Background: High sun protection factor (SPF) sunscreens have multiple benefits but there has not been validation of the test method for determining SPF values higher than 50. This study addresses specifically the accuracy and reproducibility of the high SPF test.
Methods: Two high SPF formulations with a standard reference (SPF 15) were tested at four independent test facilities according to the 2007 FDA proposed amendments to the sunscreen monograph. Statistical analysis was performed to compare the SPF results within each lab as well as the SPF results between different labs.
Results: The test formulations have overall mean values of 90.5 and 70.7. There was no statistically significant difference between the labs for either formulation and all four labs were able to statistically differentiate these two levels of SPF values. The coefficients of variance (CV) for the high SPF formulations were comparable to those of the corresponding SPF 15 reference within each lab.
Conclusions: The data show that SPF values above 50 and up to at least 90 can be measured by multiple laboratories with accuracy and reproducibility.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>21198880</pmid><doi>10.1111/j.1600-0781.2010.00561.x</doi><tpages>5</tpages></addata></record> |
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subjects | Adult Aged Biological and medical sciences coefficient of variance Dermatology Diseases of the skin. Cosmetics FDA monograph Female Humans Laboratories - standards Male Medical sciences Middle Aged Radiation Protection - standards Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) Reproducibility of Results SPF test statistical analysis Sunburn - prevention & control sunscreen Sunscreening Agents - chemistry Young Adult |
title | Multi-laboratory validation of very high sun protection factor values |
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