FDA Scorches Sunscreen Wipe Marketers With October Warning Letters

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.

FDA has issued at least five warning letters in October to marketers of sunscreen wipes and other dosage formats considered ineligible for OTC sunscreen drug review, making their offerings unapproved drugs.

Recipients include Colabs Intl. Corp., Diamond Wipes International, Inc., ITW Dymon, SCS Direct Inc. (the holding company of MD MOMS...

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