Overview

• The FDA issued five warning letters on Aug. 6 to Supergoop!, Vacation, TiZO, Kalani and K & Care for marketing mousse sunscreens without any FDA-approved OTC drug applications in that form.
• The agency flagged efficacy gaps, cautioning that mousse formulas lack approval to guarantee designed UV protection.
• Regulators classified whipped-cream–style dispensers as misbranding hazards that risk accidental ingestion, especially by children.
• Supergoop! said the FDA’s notice concerns labeling only, asserted that its PLAY SPF 50 Body Mousse is safe and effective, and said it is working with the agency.
• Kalani Sunwear temporarily removed its mousse sunscreen from U.S. sales to ensure compliance and other brands have yet to publicly respond.