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yesterday

FDA Flags Mousse and Whipped Sunscreens as Unauthorized Under OTC Rules

Companies face a 15‑working‑day deadline to avoid enforcement.

Supergoop! PLAY Body Mousse SPF 50.
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This scrutiny "presents an opportunity to revisit and expand the scope of approved dosage forms, aligning innovation with modern formats that enhance consumer experience and compliance," said D'Ruiz.

Overview

  • Warning letters dated Aug. 6 went to Supergoop!, Vacation Inc., Kalani Sunwear, Fallien Cosmeceuticals (TiZo) and K & Care Organics, citing section 505G and noting no final order or approved application authorizes foam, mousse or whip dosage forms.
  • The FDA posted a consumer alert on X that mousse sunscreens might not be effective, and experts say aerated formulas can hinder even application at the 2 mg/cm² density used to support labeled SPF.
  • Vacation’s Classic Whip packaging was deemed misleading because it resembles whipped cream, with the agency warning the look could prompt accidental ingestion.
  • Brands say the issue centers on authorization and labeling rather than product safety and report they are working with the FDA; Kalani said it removed its mousse sunscreen from its U.S. website.
  • Firms must respond within 15 working days or risk actions such as product removal, seizure or injunction, and reporting also highlights propellants like HFC‑152a that carry environmental and inhalation concerns.