title: The FDA proposed solar simulator versus sunlight.
abstract: The US Food and Drug Administration is in the process of formulating final rules for sunscreen labeling and testing. They have adopted a version of the solar simulator standard proposed by COLIPA, a European cosmetic products trade association. From our files we have selected spectral data on several solar simulators that comply with the proposed rules and have compared these sources both one to another and to several standard solar spectra of Air Mass 1.0, 1.5, and 2.0. In doing so we have used additional spectral analysis procedures including examining the goodness of fit between each solar simulator spectrum and an Air Mass 1.0 (0 degrees zenith angle) solar spectrum. The index of goodness of fit ranges from approximately 78% to just over 90% compared to solar spectra representing other Air Masses of 1.5 and 2.0, the goodness of fit is lower. Unfortunately, one may not assume that complying with a standard assures that other solar simulators also complying will produce identical results. In fact, by our analysis, none of the solar simulators we examined would be expected to produce the same SPF as sunlight.
authors.affiliation: Division of Dermatology, Department of Medicine, University of Tennessee Health Sciences Center, Memphis, TN 38103, USA. rptl@aol.com
authors.forename: Robert M
authors.initials: RM
authors.lastname: Sayre
authors.forename: John C
authors.initials: JC
authors.lastname: Dowdy
mesh_terms: D004348:Drug Labeling / Q000331:legislation & jurisprudence; D011835:Radiation Protection / Q000592:standards; D013056:Spectrophotometry, Ultraviolet / Q000379:methods*; D013472:Sunlight / Q000009:adverse effects*; D013473:Sunscreening Agents / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
chemical_list: D013473:Sunscreening Agents