OTC sunscreens
This article was originally published in The Rose Sheet
Executive Summary
FDA is requesting safety and effectiveness data on diethylhexyl butamido triazone up to 3% as a single active ingredient and in combination with other active ingredients in sunscreens, agency announces in July 26 Federal Register 1notice. FDA determined a time and extent application for the ingredient, submitted by 3V Sept. 16, 2005, was eligible for inclusion in the OTC sunscreen monograph; however, the agency notes, the TEA did not include an official or proposed U.S. Pharmacopeia-National Formulary drug monograph, and the firm should submit that information as part of the safety and effectiveness data...