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Sunscreen Industry Faces Major Challenge In GRASE Push That OTC Monograph Reform Would Solve

Executive Summary

Industry advocates working to support GRASE determinations for eight UV filters are faced with a dilemma. They would like to share nonpublic studies with the FDA on a confidential basis – at least to get initial temperature readings from the agency as to the studies’ usefulness in addressing data gaps – but under the current OTC monograph framework, no such pathway exists.

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