The U.S. is poised to offer sunscreen products comparable to those widely available in Europe, Australia, and parts of Asia. After a more than two-decade wait, the U.S. Food and Drug Administration has approved bemotrizinol, also known as BEMT, a new active sunscreen ingredient designed to protect against harmful ultraviolet radiation.
Dermatologists are expressing optimism about the ingredient’s impending arrival. "It broadens the available choices for UV protection in the U.S.," noted Dr. Marisa Garshick, a clinical dermatology professor at New York Presbyterian-Weill Cornell Medicine. "Having access to newer UV filters can help improve sunscreen formulations and hopefully encourage more consistent sunscreen use."
What sets bemotrizinol apart?
Bemotrizinol functions as a UV filter, providing protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays. While UVB rays are primarily responsible for sunburns, UVA rays also contribute to skin damage, leading to wrinkles and certain skin cancers. Dermatologists advise using sunscreens labeled "broad spectrum" for protection against both UVA and UVB.
What further excites dermatologists and consumers is bemotrizinol’s photostability. This means it maintains its effectiveness in sunlight for longer periods compared to some other UV filters. It doesn’t degrade quickly and can enhance the performance of other sunscreen components. Dr. Mona A. Gohara, a dermatology professor at Yale School of Medicine, highlighted that bemotrizinol also blends well into formulations, leading to more aesthetically pleasing sunscreens with a reduced likelihood of leaving a white cast. Its extensive history of use globally has demonstrated a strong safety profile with minimal skin absorption.
Concerns sometimes raised on social media about certain chemical filters, such as oxybenzone, being absorbed into the bloodstream and potentially interfering with hormones have not been substantiated in humans.
Additional information on bemotrizinol:
The FDA has deemed bemotrizinol safe for both adults and children as young as six months old. While, as with any skincare product, some individuals might experience mild skin irritation or sensitivity, serious adverse reactions are rare. Dr. Garshick advises those with sensitive skin to perform a patch test before using new products, especially if they have a history of sensitivities.
Experts emphasize that bemotrizinol, while a welcome addition, is not a miracle solution. "Bemotrizinol is an exciting addition, but no sunscreen ingredient is magic," Dr. Gohara stated. "Consistent sunscreen use matters far more than chasing the newest ingredient." Dermatologists continue to recommend broad-spectrum sunscreens with an SPF of 30 or higher, applied generously and reapplied at least every two hours.
Reasons for delayed U.S. approval:
The United States classifies sunscreen as an over-the-counter drug, subjecting new ingredients to a rigorous and often lengthy FDA review process. In contrast, Europe regulates sunscreen as a cosmetic product.
Although the initial application for bemotrizinol was submitted in 2005, progress was slow. In 2024, the manufacturer reapplied using an expedited administrative pathway established by the CARES Act of 2020. The FDA’s final order approving bemotrizinol was issued in June 2024, and it will take effect in August 2026.
Availability of sunscreen with bemotrizinol:
Currently, acquiring sunscreen with bemotrizinol is only possible outside the U.S. The ingredient, marketed under the brand name Parsol Shield, is expected to be available in U.S. products shortly after the FDA’s final order becomes effective. The manufacturer holds exclusive marketing rights in the U.S. for 18 months, with the first sunscreens featuring this filter anticipated to reach shelves in September.