DISPARATE SPF TESTING METHODOLOGIES 307 harmonization the disparate mathematical alteration of the mean SPF value, or lack thereof, is the only signifi cant factor remaining to be resolved. REFERENCES (1) Department of Health and Human Services, Food and Drug Administration, Sunscreen Drug Prod- ucts for Over-the-Counter Human Use Final Monograph, Federal Register, 64, 27666–27693 (1999). (2) Department of Health and Human Services, Food and Drug Administration, Sunscreen Drug Products for Over-the-Counter Human Use Proposed Amendment of Final Monograph Proposed Rule, Federal Register, 72, 49070–49122 (2007). (3) Department of Health and Human Services, Food and Drug Administration, Labeling and Effectiveness Testing Sunscreen Drug Products for Over-the-Counter Human Use, Federal Register, 76, 35620– 35665 (2011). (4) The Australian/New Zealand Standard™, Sunscreen Products - Evaluation and classifi cation, AS/NZS 2604: 1998. (5) COLIPA, International Sun Protection Factor (SPF) Test Method, February 2003 (Joint Conference on Harmonization, Colipa, JCIA, and CTFA SA). (6) COLIPA, International Sun Protection Factor (SPF) Test Method, May 2006 (Joint Conference on Har- monization, Colipa, JCIA, CTFA SA and CTFA). (7) Cosmetics – Sun protection test methods – In vivo determination of the sun protection factor (SPF), ISO 24444:2010(E). (8) The Australian/New Zealand Standard™, Sunscreen Products - Evaluation and classifi cation, AS/NZS 2604: 2012. (9) Cosmetics-Sun protection test methods- Review and evaluation of methods to assess the photoprotec- tion of sun protection products. ISO/TR 26269:2009(E) 3–9. (10) D.S. Berger, Specifi cation and design of solar ultraviolet simulators, J Invest Dermatol., 53, 192–199 (1969). (11) M. Caswell, C. Wood, G. Roberts, and A. Martinez “No difference detected in SPF determined using a 300 watt solar simulator versus a 150 watt solar simulator,” 19th Annual Photomedicine Society Meet- ing, March 3, 2010. (12) P. Agin and S. Edmonds, Testing high SPF sunscreens: a demonstration of the accuracy and reproduc- ibility of the results of testing high SPF formulations by two methods and at different testing sites, Photodermatol. Photoimmunol. Photomed., 18, 169–174 (2002). (13) M. Caswell, C. Wood, and E. Maly, Water immersion does not alter the minimal erythema dose, J. Cosmet. Sci.,62, 327–329 (2011).
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