The U.S. Food and Drug Administration (FDA) plays a crucial role in regulating the safety and efficacy of sunscreens. New sunscreen products can enter the market through an over-the-counter drug review process, which establishes guidelines on when these products are deemed “generally recognized as safe and effective” (GRASE) for their intended use. A significant aspect of this framework involves identifying and evaluating active ingredients.

DSM Nutritional Products LLC, a company with headquarters in Switzerland and the Netherlands, has recently requested that the FDA approve the use of bemotrizinol as a new active ingredient in U.S. sunscreens, according to a statement from the FDA.

The FDA has now opened this request for public comment and will assess the safety and effectiveness of bemotrizinol under the GRASE framework. This evaluation will determine if a final order should be issued to include bemotrizinol on the list of approved active ingredients for sunscreens.

“Bemotrizinol would be a welcome addition to the current array of effective sunscreen active ingredients already available to American consumers,” said Dr. Karen Murry, acting director of the FDA’s Office of Nonprescription Drugs, in a statement.

The majority of skin cancers are caused by too much exposure to ultraviolet radiation, which comes from the sun as well as tanning beds or sun lamps.

Staying in the shade and wearing UV-protective clothing, hats and sunglasses can all reduce exposure, but sunscreens, chemical or mineral, are also important tools to protect skin.

Chemical sunscreens – such as avobenzone, oxybenzone, octocrylene, ecamsule, homosalate, octisalate and octinoxate – bind to the top layer of skin and transform UV rays into heat that disperses. Mineral sunscreens, such as zinc oxide and titanium dioxide, form a protective barrier between the skin and the sun.