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Sunscreen call for data

This article was originally published in The Tan Sheet

Executive Summary

FDA is seeking submissions of safety and efficacy data for diethylhexyl butamido triazone, up to 3%, as a sunscreen single active ingredient and in combination with other sunscreen active ingredients, according to a Federal Register notice July 26. The agency has reviewed a Time & Extent Application for the ingredient submitted in 2005 by 3V Inc. and has determined that it is eligible for inclusion in an OTC monograph. FDA notes, however, that the TEA did not include an official or proposed U.S. Pharmacopoeia National Formulary (USP-NF) drug monograph for diethylhexyl butamido triazone, and an official or proposed USP-NF must be included as part of the safety and effectiveness data for the ingredient. The deadline for submissions is Oct. 26...
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