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Octyl triazone

This article was originally published in The Tan Sheet

Executive Summary

BASF asks for 90-day extension to respond to FDA's request for data on octyl triazone sunscreen; the previous deadline was Oct. 9. Firm maintains more time is needed to compile recent effectiveness data. Beiersdorf submitted a separate letter Oct. 7 in support of BASF's time and extent application, noting the German firm has used the ingredient in its own sun care products outside the U.S. for more than five years without "unusual adverse event experience." FDA requested safety data on octyl triazone and two other sunscreen ingredients in a July 11 Federal Register notice (1"The Tan Sheet" July 14, 2003, In Brief)...

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FDA requests safety and efficacy data on three sunscreens based on its determination that time and extent applications indicate the ingredients are "eligible for consideration" for inclusion in OTC monograph, according to 1July 11 Federal Register notice. Data sought on amiloxate (isoamyl p-methoxycinnamate), enzacamene (methyl benzylidene camphor) and octyl triazone by Oct. 9. TEAs for ingredients were filed by Haarmann & Reimer, Merck KgaA and BASF AG, respectively. Agency will make a final decision on ingredients' status following review of submitted information...

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Global Pharma Guidance Tracker – March 2020

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.





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