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

This article was originally published in The Rose Sheet

Executive Summary

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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