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OTC SUNSCREENS WITH SPFs GREATER THAN 20

Executive Summary

OTC SUNSCREENS WITH SPFs GREATER THAN 20 have potential for dermatologic toxicity, Frederick Urbach, MD, Temple University School of Medicine, said at a Jan. 26 public meeting. "The sunscreens with SPFs greater than 20 will only increase cost and make the possibility of irritation by multiple sunscreen materials [and their photo breakdown products] more likely," Urbach stated. FDA held the meeting to discuss a 1978 advisory panel's recommendations for testing procedures of OTC sunscreen drug products. The agency will take comments made at the meeting into consideration when preparing the tenative final monograph. The closing date for comments is April 26, 1988. In a Sept. 4, 1987 Federal Register notice, FDA published the proposed rules on the testing procedures for sunscreens ("The Pink Sheet" Sept. 7, T&G-10). In that notice FDA pointed out that since the panel's report, a number of sunscreens with SPFs greater than 15 have entered the market and that the agency needs data on these products. Discussing the differences between SPFs, Urbach said that there is "a significant difference" between an SPF of 2 and an SPF of 4, "but when you get to the difference between 28 and 30 it's immaterial. What . . . is the difference when you protect for seven and one-half hours or nine and one-half hours? Nobody can stay out long enough or get enough ultraviolet to [need] this." Echoing Erbach's position, Madhu Pathak, PhD, Massachusetts General Hospital Department of Dermatology, said: "Unless the industry shows the evidence or data that the consumer needs sunscreens with high SPF values of 30 or 35, we sincerely urge the agency to maintain a maximum SPF value of 20. It is not necessary to have 'extra potent" sunscreens with SPF vlues of 25, 30, 35 etc., and to subject the consumer's skin to potentially toxic effects of high concentrations of chemicals." Schering-Plough Senior VP-Scientific and Regulatory Affairs, John Clayton, PhD, stated that the issue of sensitization from the high SPF sunscreens is "more a risk-benefit relationship than it is [a] specific concern about adverse effects of individual ingredients. There is a strong medical justification in support for SPFs higher than 15, however, the justification does not support SPFs higher than 30," Clayton contended. "We feel that the agency should mandate a cap on SPFs at 30, in view of the lack of sufficient benefit to justify the increase sunscreen exposure," he said. Addressing the issue of product category designations, Johnson & Johnson VP-scientific affairs Bruce Semple, MD, suggested that for sunscreens in the higher SPF range, two new categories be added to the end of the scale. He proposed an SPF of 25 for products with SPFs of 25 to under 30, and an SPF of 30, for products with SPFs of 30 and above. When the question was raised of whether an appropriate sunscreen formula was available as a control for testing sunscreens, Curtis Cole, PhD, Johnson & Johnson, revealed that his company was willing to provide formulations of its SPF 8 and SPF 20 waterproof products for use as high SPF and waterproof reference standards.
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