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FDA Scorches Sunscreen Wipe Marketers With October Warning Letters

This article was originally published in The Rose Sheet

Executive Summary

Inspections conducted over the past year may have contributed to a wider FDA crackdown on unapproved sunscreen drug products – specifically those in dosage forms deemed ineligible under OTC drug review for inclusion in the sunscreen monograph – with five marketers targeted so far this month with warning letters.

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