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FDA Proposal For Increased Sunscreen Safety Testing On NDAC Agenda

This article was originally published in The Rose Sheet

Executive Summary

FDA’s Nonprescription Drug Advisory Committee will consider proposed tests for evaluating the safety of sunscreen ingredients that sponsors want to add to the OTC monograph. The committee will not consider the safety or efficacy of specific ingredients pending review via TEAs.

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NDAC members agree with FDA’s proposed standards for evaluating the safety of sunscreen monograph ingredients, but suggest the agency add tests to evaluate the impact of long-term use, actual use and bioavailability in specific populations.

Existing Sunscreen Monograph Ingredients Could Fail Proposed Safety Standards

FDA’s proposed safety standards for sunscreen monograph ingredients might not align with safety evidence supporting current monograph ingredients. Without a safeguard, such as a grandfather clause, these ingredients could face challenges if FDA adopts stricter standards, NDAC committee members worry.

L’Oreal Sunscreen TEA Falls Short On Safety, Efficacy, AE Data

Ahead of NDAC’s discussion of tests for evaluating the safety of sunscreen ingredients, FDA issues its fourth letter this year to sunscreen TEA applicants citing insufficient data. FDA says it needs additional data on safety, efficacy and adverse events from L’Oreal to determine GRASE for drometrizole trisiloxane, marketed as Mexoryl XL.

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