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FDA’s ‘Exploratory’ MUsT Won't Affect OTC Sunscreen Rulemaking Schedule

This article was originally published in The Rose Sheet

Executive Summary

FDA’s plans for a maximal usage study to better understand sunscreen ingredient absorption should not hold up delivery of a final OTC sunscreen monograph by the end of 2019, the agency says. There are questions among industry stakeholders as to how FDA’s research relates to MUsTs currently requested from TEA sponsors seeking GRASE approvals.

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