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Executive Summary

SUNSCREEN SPF DESIGNATION TESTING DATA SOUGHT BY FDA to revise a 1978 advisory panel report on OTC sunscreen products. In a Sept. 4 Federal Register notice, FDA announced a public meeting and the reopening of the administrative record for discussion and comments on the recommendations of the advisory panel on "testing procedures for determination of the sun protection factor (SPF) value and related claims." The meeting will be held Jan. 26, 1988; the administrative record will remain open until April 26, 1988. Among the topics to be addressed is whether the panel's proposed general and statistical methods for sunscreen testing are currently valid for SPF designations of more than 15. "The agency is aware that, recently, a number of sunscreen drug products have been marketed with SPF values greater than 15, which was the panel's highest classification," FDA noted, adding: "Companies marketing such products should provide supporting data. If the currently recognized sunscreen testing procedures are not adequate, what tests are necessary to determine SPF values higher than 15?" FDA said it has received no information to date on testing for SPF 15-plus products. The agency is also seeking information on product category designations (PCDs). "If products having SPF values much higher than 15 are determined to be rational, how should the panel's recommended PCDs be modified to include these" values, FDA asked. The panel's recommended PCDs included "minimal, moderate, extra, maximal and ultra." One possible adaptation of those designations would be to characterize SPFs of 12-20 as "maximal" and 20 and above as "ultra," the agency suggested. FDA is further requesting comments on ways to assess differing levels of protection based on a product's ability to be "sweat resistant," "water resistant," and "waterproof." The agency also expects to address such aspects of final product testing as standard formulations, the number of subjects needed, exposure time and the amount of sunscreen used.

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