FDA proposes updates to sunscreen requirements

The FDA has proposed revisions to the marketing conditions for over-the-counter sunscreen products in order to improve safety and efficacy, according to a press release.

The proposed revisions include updates to the maximum sun protection factor (SPF) values, active ingredients, broad spectrum requirements and product labeling.

They include an update to the generally recognized as safe and effective (GRASE) status for 16 active ingredients and for dosage forms including oils, lotions, creams, gels, butters, pastes, ointments and sticks. The revisions also propose GRASE status for spray sunscreens, subject to testing and labeling requirements.

“Sun safety is important for everyone, regardless of your skin tone. Americans can reduce risks from sun exposure with continued use of sun protection measures including broad spectrum sunscreen with SPF values of at least 15,” Acting FDA Commissioner Janet Woodcock, MD, said in the release. “Today’s activities represent a key milestone in our implementation of transformative new authorities related to OTC drugs that will allow us to continue ensuring that sunscreens are safe and effective for frequent, lifelong use and provide consumers with the protection they expect from these products.”

The proposal also ensures sunscreens contain adequate ultraviolet A (UVA) protection and updates product labeling guidelines to make it easier for buyers to identify product information.

The American Academy of Dermatology applauded the FDA’s efforts to improve sunscreen safety.

“Sunscreen is an important tool in the fight against skin cancer, including melanoma, the deadliest form of skin cancer. The Academy appreciates the FDA’s mission to ensure the safety and effectiveness of over-the-counter sunscreen products based on sound science and supports orders that ensure the public has access to safe and effective sunscreens,” AAD President Kenneth J. Tomecki, MD, FAAD, said in a statement. “Unprotected exposure to the sun’s ultraviolet rays is a major risk factor for skin cancer. The Academy recommends a comprehensive sun protection plan that includes seeking shade; wearing protective clothing, including a lightweight, long-sleeved shirt, pants, a wide-brimmed hat and sunglasses; and applying a broad-spectrum, water-resistant sunscreen with an SPF of 30 or higher to uncovered skin.”

Comments on the proposed order will be accepted during a 45-day public comment period before a revised final order is issued.

Editor's note: This article has been updated to include a statement from the American Academy of Dermatology.