'Beware' Mousse-Based Sunscreen, FDA Warns

Published: Wednesday, August 20, 2025 at 12:53 pm

FDA Warns Consumers About Mousse Sunscreens

The Food and Drug Administration (FDA) has issued a warning regarding the efficacy of sunscreen products in mousse form. The agency has sent warning letters to five companies marketing mousse-style sunscreens, citing concerns about efficacy, regulatory violations, and potential packaging risks.

The FDA's review of product labeling, including websites, revealed that some mousse sunscreens are marketed as over-the-counter (OTC) sunscreen drugs. However, the FDA has not approved relevant applications for these products. The FDA also warned that some mousse sunscreen products resemble whipped cream containers, which could pose a risk if ingested.

Dermatologist Professor Adam Friedman of George Washington University explained that sunscreens are regulated as OTC drugs, with specific expectations for efficacy and safety. He noted that the current FDA "monograph" of approved sunscreen formulations does not include mousses or foams. Friedman expressed concern that the formulation of mousse sunscreens may not allow UV filters to behave the same way as in approved formulations, making it difficult to guarantee their effectiveness and safety.

Friedman advises consumers to choose sunscreens that follow the monograph and to consider larger brand companies that have the resources to study their products and ensure they meet FDA guidelines. He recommends using sunscreens with an SPF of 30 or higher, broad spectrum, and water-resistant for at least 80 minutes. He also emphasizes the importance of patch testing to ensure the product is well-tolerated and rubs in well.

The companies, including Supergoop!, Vacation Inc., and Kalani Sunwear, have responded to the warning. Supergoop! stated that the FDA's communication focuses on product labeling and does not concern safety, effectiveness, or formula. Vacation Inc. expressed confidence in the safety, efficacy, and integrity of its product. Kalani Sunwear has voluntarily paused sales in the U.S. while reviewing administrative requirements.

BNN's Perspective: The FDA's warning highlights the importance of regulatory oversight in the sunscreen industry. While the availability of diverse sunscreen options is welcome, consumers should prioritize products that meet established safety and efficacy standards. This situation underscores the need for consumers to be informed and to choose sunscreens carefully, prioritizing products that have undergone rigorous testing and adhere to FDA guidelines.

Keywords: FDA, sunscreen, mousse, warning, efficacy, safety, SPF, broad spectrum, regulatory, OTC, Supergoop!, Vacation Inc., Kalani Sunwear, dermatologist, UVA, UV filters

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