FDA Issues Warning on Foam, Mousse, and Whipped Sunscreens

The Food and Drug Administration (FDA) has released a warning urging consumers to avoid sunscreens marketed in foam, mousse, and whipped forms. These products have not been approved as effective delivery methods for sun protection, raising concerns over their safety and efficacy.

What You Need to Know

• Misbranding Concerns: The FDA has identified several companies, including well-known brand Supergoop, for selling these products without appropriate FDA approval. These sunscreens are labeled as drugs but fail to adhere to the established guidelines for over-the-counter (OTC) products.

• Legal Implications: Marketing sunscreens that do not meet FDA criteria is classified as illegal under federal law. Selling misbranded drugs poses a significant risk to consumer safety, prompting this official warning.

FDA’s Regulatory Framework

The FDA oversees sunscreens as OTC drugs to ensure consumers have access to safe and efficient sun protection. The agency’s strict regulations specify which forms of sunscreens can be marketed. Currently approved forms include:

• Oils
• Lotions
• Creams
• Gels
• Butters
• Pastes
• Ointments
• Sticks

Foams, mousses, and whipped formulations are not included in this list, as they have not been subject to FDA review.

The Approval Process

For sunscreens to be sold in new formats, manufacturers must submit new drug applications. As of now, the FDA has not received any such applications for foam or mousse formulations. This lack of regulatory approval could jeopardize consumer safety, as these products could deliver inadequate sun protection.

Updates on Sunscreen Regulations

In 2019, the FDA proposed new rules to modernize its regulations regarding sunscreens. The updates aimed to:

• Revise active ingredient requirements
• Set maximum sun protection factor (SPF) levels
• Establish broad-spectrum protection standards against both UVA and UVB rays
• Improve dosage forms, including creams, lotions, and sprays
• Clarify labeling to help consumers easily identify crucial information

Importance of Strong Oversight

The Skin Cancer Foundation emphasizes the necessity for stringent oversight in sunscreen regulations. As scientific advancements continue to enhance sunscreen efficacy, ongoing evaluation of products and the introduction of new UV filters is essential for consumer safety. The foundation advocates for strong compliance with FDA guidelines to facilitate better sun protection for all.

For further reading and updates on this matter, visit the FDA’s Official Page and the Skin Cancer Foundation.