{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,9,2]],"date-time":"2025-09-02T10:35:56Z","timestamp":1756809356297},"reference-count":9,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2002,10,4]],"date-time":"2002-10-04T00:00:00Z","timestamp":1033689600000},"content-version":"vor","delay-in-days":64,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Photoderm Photoimm Photomed"],"published-print":{"date-parts":[[2002,8]]},"abstract":"<jats:p><jats:bold>Background\/Purpose:<\/jats:bold> The goals of this study were (i) to demonstrate that existing and widely used sun protection factor (SPF) test methodologies can produce accurate and reproducible results for high SPF formulations and (ii) to provide data on the number of test\u2010subjects needed, the variability of the data, and the appropriate exposure increments needed for testing high SPF formulations.<\/jats:p><jats:p><jats:bold>Methods:<\/jats:bold> Three high SPF formulations were tested, according to the Food and Drug Administration's (FDA) 1993 tentative final monograph (TFM) \u2018very water resistant\u2019 test method and\/or the 1978 proposed monograph \u2018waterproof\u2019 test method, within one laboratory. A\u00a0fourth high SPF formulation was tested at four independent SPF testing laboratories, using the 1978 waterproof SPF test method. All laboratories utilized xenon arc solar simulators.<\/jats:p><jats:p><jats:bold>Results:<\/jats:bold> The data illustrate that the testing conducted within one laboratory, following either the 1978 proposed or the 1993 TFM SPF test method, was able to reproducibly determine the SPFs of the formulations tested, using either the statistical analysis method in the proposed monograph or the statistical method described in the TFM. When one formulation was tested at four different laboratories, the anticipated variation in the data owing to the equipment and other operational differences was minimized through the use of the statistical method described in the 1993 monograph.<\/jats:p><jats:p><jats:bold>Conclusions:<\/jats:bold> The data illustrate that either the 1978 proposed monograph SPF test method or the 1993 TFM SPF test method can provide accurate and reproducible results for high SPF formulations. Further, these results can be achieved with panels of 20\u201325 subjects with an acceptable level of variability. Utilization of the statistical controls from the 1993 sunscreen monograph can help to minimize lab\u2010to\u2010lab variability for well\u2010formulated products.<\/jats:p>","DOI":"10.1034\/j.1600-0781.2002.00767.x","type":"journal-article","created":{"date-parts":[[2003,3,12]],"date-time":"2003-03-12T18:35:51Z","timestamp":1047494151000},"page":"169-174","source":"Crossref","is-referenced-by-count":3,"title":["Testing high SPF sunscreens: a demonstration of the accuracy and reproducibility of the results of testing high SPF formulations by two methods and at different testing sites"],"prefix":"10.1111","volume":"18","author":[{"given":"Patricia Poh","family":"Agin","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susan H.","family":"Edmonds","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2002,10,4]]},"reference":[{"key":"e_1_2_6_2_2","unstructured":"Federal Register:May 21 1999 64 no. 98.Final Rule.27666\u201327693."},{"key":"e_1_2_6_3_2","unstructured":"Federal Register:May 12 1993 58 no. 90. Tentative Final Monograph.28194\u201328302."},{"key":"e_1_2_6_4_2","unstructured":"Federal Register:August 25 1978 43 no. 166.Proposed Rulemaking.38206\u201338269."},{"key":"e_1_2_6_5_2","unstructured":"COLIPA.COLIPA Sun Protection Factor Test Method The European Cosmetic Toiletry and Perfumery AssociationOctober 1994: ref 94\/289."},{"key":"e_1_2_6_6_2","unstructured":"Australia\/New Zealand Standard.Sunscreen Products\u2010Evaluation and Classification AS\/NZS1997:2604."},{"key":"e_1_2_6_7_2","unstructured":"Japan Cosmetic Industry Association Standard SPF Test MethodMay 18 1999 Revised."},{"key":"e_1_2_6_8_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0781.2001.170606.x"},{"key":"e_1_2_6_9_2","first-page":"347","volume-title":"Biological Responses to UVA Radiation","author":"Agin PP.","year":"1992"},{"key":"e_1_2_6_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/0190-9622(90)70236-B"}],"container-title":["Photodermatology, Photoimmunology &amp; Photomedicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1034%2Fj.1600-0781.2002.00767.x","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1034%2Fj.1600-0781.2002.00767.x","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1034\/j.1600-0781.2002.00767.x","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,17]],"date-time":"2023-10-17T08:06:35Z","timestamp":1697529995000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1034\/j.1600-0781.2002.00767.x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2002,8]]},"references-count":9,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2002,8]]}},"alternative-id":["10.1034\/j.1600-0781.2002.00767.x"],"URL":"https:\/\/doi.org\/10.1034\/j.1600-0781.2002.00767.x","archive":["Portico"],"relation":{},"ISSN":["0905-4383","1600-0781"],"issn-type":[{"value":"0905-4383","type":"print"},{"value":"1600-0781","type":"electronic"}],"subject":[],"published":{"date-parts":[[2002,8]]}}}