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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.

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Octyl triazone

Hawaiian Tropic Tanning Research Laboratories is "fully supportive" of BASF's Time and Extent Application for Uvinul T-150 (octyl triazone), company says in Jan. 7 comments to FDA. While Hawaiian Tropic has not worked with the sunscreen, literature indicates it is a strong UVB absorber with additional advantage of being photostable, firm states. "The list of sunscreens available for use in the U.S. is relatively small when compared to those available in Europe," Hawaiian Tropic says. "To develop the best possible products for the U.S. consumer, sunscreen manufacturers need as many sunscreen choices as possible." Johnson & Johnson earlier submitted comments supporting the TEA. BASF first petitioned FDA to designate octyl triazone a Category I sunscreen ingredient in 1996 (1"The Rose Sheet" Dec. 2, 1996, p. 8)...

Octyl triazone

Hawaiian Tropic Tanning Research Laboratories is "fully supportive" of BASF's Time and Extent Application for Uvinul T-150 (octyl triazone), company says in Jan. 7 comments to FDA. While Hawaiian Tropic has not worked with the sunscreen, literature indicates it is a strong UVB absorber with additional advantage of being photostable, firm states. "The list of sunscreens available for use in the U.S. is relatively small when compared to those available in Europe," Hawaiian Tropic says. "To develop the best possible products for the U.S. consumer, sunscreen manufacturers need as many sunscreen choices as possible." Johnson & Johnson earlier submitted comments supporting the TEA. BASF first petitioned FDA to designate octyl triazone a Category I sunscreen ingredient in 1996 (1"The Rose Sheet" Dec. 2, 1996, p. 8)...

J&J supports BASF ingredient

FDA should expedite review of BASF's Time & Extent Application for UVB absorber octyl triazone, marketed in Europe as Uvinul T-150, Johnson & Johnson says in an Oct. 7 letter to the agency. While J&J "has no experience with this ingredient, we are aware of the limited choices available for sunscreen actives," company states. BASF first petitioned FDA to designate octyl triazone a Category I sunscreen ingredient in November 1996, based on foreign marketing experience (1"The Rose Sheet" Dec. 2, 1996, p. 8). The ingredient has been marketed in Europe since 1989 and in Japan since 1996. FDA barred interim marketing of OTC drugs in the U.S. in its final rule on "material time, material extent" criteria, and noted pending citizen petitions from sunscreen ingredient suppliers could be converted to TEAs for agency consideration of monograph eligibility (2"The Rose Sheet" Jan. 29, 2002, p. 8)...

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