The U.S. Food and Drug Administration (FDA) has proposed adding bemotrizinol to its list of permitted active ingredients for use in sunscreens — marking the agency’s first potential addition of a new sunscreen active ingredient in more than 20 years.
Already used in many countries outside of the U.S., bemotrizinol provides protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays, has low levels of absorption through the skin, and rarely causes skin irritation.
Safety, Stability, and Tolerability
The request to approve bemotrizinol at concentrations of up to 6% was submitted to the FDA by DSM Nutritional Products LLC. If determined safe, bemotrizinol will be an additional sunscreen active ingredient available for use in products intended for adults and children as young as six months of age.
“Bemotrizinol has been approved in Europe, Australia, Japan and other countries for more than two decades, and it has a steadfast track record for safety and tolerability,” said Sairekha Ravichandran, MD, a dermatologist at the Moffitt Cancer Center, in a statement following the FDA’s announcement. “One drawback of some chemical sunscreens we have now is that they can become unstable and break down when exposed to sunlight.
“But not bemotrizinol,” she added. “This is a very stable sun filter that may even help to stabilize other unstable filters when added to a sunscreen formulation.”
Bemotrizinol is being reviewed under the FDA’s over-the-counter (OTC) sunscreen monograph. If finalized, it could be marketed without a formal FDA-approved drug application, as long as manufacturers comply with monograph requirements regarding permitted ingredients, uses, and dosing.
Sunscreen and Skin Cancer Prevention
Skin cancer is the most common cancer in the U.S. and worldwide, and the American Academy of Dermatology (AAD) recommends regular sunscreen use with an SPF of 30 or higher for people of all skin types.
Key statistics underscore the importance of effective sun protection:
- 1 in 5 Americans will develop skin cancer by the age of 70
- More than 2 people die of skin cancer in the U.S. every hour
- Having 5 or more sunburns doubles the risk of melanoma
Given strong evidence that sunscreen reduces the risk of developing both melanoma and nonmelanoma skin cancer, the AAD recommends photoprotection strategies. This includes avoiding midday sun, seeking shade, wearing protective clothing, and using sunscreen when sun exposure cannot be avoided.
The FDA’s proposed addition of bemotrizinol, coming just weeks after the SAFE Sunscreen Standards Act was signed into law, reflects a broader effort to modernize sunscreen regulation and expand available options for U.S. consumers.
“The agency has historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad,” said FDA Commissioner Marty Makary, MD. “We’re continuing to modernize the regulation of sunscreen and other over-the-counter drug products. Americans deserve timely access to the best safe, effective and consumer-friendly over-the-counter products available.”
