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Octyl triazone inclusion in sunscreen monograph based on foreign use data sought by BASF.

This article was originally published in The Tan 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 D.C. law office of Morgan, Lewis & Bockius, the German firm BASF asks FDA to reopen the administrative record of the OTC Sunscreen Drug Products Review to include octyl triazone, which BASF sells overseas under the trade name Uvinul T 150. The ingredient was approved in the EU member countries in 1989 and in Japan this March.

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