Octyl triazone inclusion in sunscreen TFM based on foreign use data sought by BASF.
This article was originally published in The Rose Sheet
Executive Summary
OCTYL TRIAZONE INCLUSION IN SUNSCREEN MONOGRAPH SOUGHT BY BASF AG as a Category I (generally recognized as safe and effective) sunscreen ingredient on the basis of its foreign marketing experience. In a Nov. 15 petition filed by the Washington, D.C. office of Morgan, Lewis & Bockius, Germany-based BASF asks FDA to reopen the administrative record of the OTC Sunscreen Drug Products review to include octyl triazone, which the company sells overseas under the trade name Uvinul T 150. The ingredient was approved in the European Union in 1989 and in Japan in March.