Overview

• On August 6, the FDA issued warning letters to Supergoop!, Vacation Inc., Kalani Sunwear, Fallien Cosmeceuticals/TiZo and K & Care Organics for marketing whipped, mousse and foam sunscreens without approved OTC applications.
• Companies have 15 working days to respond or face enforcement actions, including potential product removal from U.S. shelves.
• Regulators warned aerated formulations may not achieve the 2 mg/cm² application density required for SPF claims, increasing the risk of sunburn.
• Vacation Inc.’s Classic Whip was flagged as misbranded because its whipped-cream style canister could prompt accidental ingestion, especially by children.
• At least one mousse product contains hydrofluorocarbon-152a, a refrigerant with high global-warming potential and documented inhalation hazards.