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L'Oreal seeks interim approval for ecamsule

This article was originally published in The Rose Sheet

Executive Summary

FDA should allow the interim marketing of ecamsule as a sunscreen active ingredient while the Sunscreen Drug Products for Over-the-Counter Human Use final monograph is pending, according to a July 10 citizen petition submitted by L'Oreal. Interim availability of ecamsule (terephthalylidene dicamphor sulfunic acid) "would allow consumers to have more immediate access to a wider range of products" that protect against short-wave-length UVA, which is "not covered by the bulk of OTC sunscreen ingredients." Ecamsule is approved for marketing in the U.S. as part of four separate new drug applications and is the subject of a time and extent application under consideration by FDA, L'Oreal notes. FDA has declared ecamsule eligible for inclusion in the sunscreen monograph and aims to propose a rule on TEAs for sunscreen ingredients by May 2010
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