FDA Issues Warning on Foam & Mousse Sunscreens – Here’s Why It Matters

Provision Consulting Group
6 hours ago
2 min read

FDA Warns: “Mousse and Foam Sunscreens Are Not Yet Approved”

Sunscreen is a summertime essential, and in recent years it has expanded beyond traditional creams and lotions to include innovative mousse and foam formats.

However, the FDA recently issued warning letters to several companies marketing these new formulations. Brands such as Supergoop!, Vacation Inc., Kalani Sunwear, K & Care Organics, and Fallien Cosmeceuticals (TiZo) were included.

The FDA pointed out that these mousse or whipped products do not fall under the approved OTC (over-the-counter) sunscreen dosage forms (such as creams, lotions, and gels) and are being sold without proper regulatory clearance.

One concern is that whipped-style packaging could be mistaken for whipped cream, posing a risk of confusion, particularly for children.

New textures or formulations require separate approval

The FDA further emphasized that even if the active formula meets regulatory standards, a new texture or dosage form is considered a separate approval category. For mousse products, the high air content makes it difficult for consumers to gauge whether they are applying a sufficient amount of SPF protection.

Ultimately, the FDA clarified that the issue is not about the safety or efficacy of these products, but rather that their labeling and dosage form raise regulatory concerns. As one brand noted, the product itself may be safe, but compliance with proper labeling requirements is the central issue.

Innovation vs. Regulation: Finding the Balance

Innovation in texture and design can be exciting, but without regulatory validation, it can quickly become a risk. K-Beauty brands in particular should carefully review whether new dosage forms fall within FDA’s approved categories before launching.

For mousse or foam sunscreens, FDA pre-approval or a clear regulatory interpretation will be essential for future success.

At Provision Consulting Group, we help companies stay ahead by

identifying regulatory risks early and offering tailored label and formulation review services.

If you have any questions or would like guidance, please feel free to contact us.

Office: 1-909-493-3276

Email: ask@provisionfda.com

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