Sunscreens are a crucial and well-recognized tool in the fight against skin cancer. The dangers of excessive sun exposure are clear and universally recognized by public health professionals, including prominent dermatologists. As part of the revised regulation of sunscreens, the U.S. Food and Drug Administration (FDA) issued a proposed Administrative Order today, largely mirroring provisions made in its 2019 Tentative Final Monograph (TFM). These include revisions and updates related to maximum sun protection factor (SPF) values, active ingredients, broad spectrum requirements and product labeling.
As part of today’s proposed Administrative Order, the FDA is reiterating its request for additional data for some sunscreen filters currently approved in the U.S. to further evaluate their status as generally recognized as safe and effective (GRASE). Importantly, sunscreens made with these ingredients are not considered unsafe by the FDA and will remain on the market to be used as part of consumers’ sun-safe practices while more data are collected. Not all of these ultraviolet (UV) filters are used in formulations marketed today.
In the U.S., sunscreen products are regulated by the FDA as non-prescription, over-the-counter (OTC) drug products. Our industry has long supported OTC monograph reform, and our member companies remain committed to working with the FDA to further demonstrate the safety of UV filters in sunscreens – avobenzone, oxybenzone, octocrylene, octisalate, octinoxate, homosalate, ensulizole and meradimate. These filters are approved globally in Europe and other regions around the world and have been used in formulations in the U.S. for decades.
Numerous nonprofit health organizations and government agencies worldwide, including the U.S. Centers for Disease Control and Prevention (CDC), American Academy of Dermatology (AAD) and Skin Cancer Foundation, recommend continuing to use sunscreens as part of a safe-sun regimen. The FDA noted in its announcement of the proposed Order, ‘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.’ Ensuring consumers have access to sunscreen products containing UVA protection is an important contribution to the FDA’s public health mission.
The personal care and consumer healthcare products industries have a long history of working to improve the well-being of the people who trust and rely on our products every day. Our goal is to provide consumers with access to a wide variety of safe, effective and innovative sunscreens to meet the differing needs of individuals and their families. Sunscreen products protect consumers from harmful UV rays that can cause premature aging and skin cancer. We hope that using sunscreen becomes as much of a health habit as putting on your seatbelt.