CHPA Welcomes FDA Addition of First New Sunscreen Active Ingredient in More Than 25 Years

WASHINGTON, D.C. - The Consumer Healthcare Products Association (CHPA) today welcomed the U.S. Food and Drug Administration's (FDA) addition of bemotrizinol (BEMT) to the list of sunscreen active ingredients approved for use in the United States. This marks the first new sunscreen active ingredient that has been added to the OTC sunscreen monograph since 1999 and is a major milestone for the modernized monograph system established under the Over-the-Counter Monograph User Fee Act (OMUFA).

This follows FDA's review of an Over-the-Counter Monograph Order Request (OMOR), representing the first OMOR to successfully advance through the modernized administrative order pathway created by Congress in 2020.

"Today's action represents meaningful forward momentum toward expanding Americans' access to innovative sunscreen filters and modern self-care options," said CHPA President & CEO Scott Melville. "For decades, Americans have had access to fewer sunscreen filter options than consumers in many other countries, despite skin cancer remaining the most common cancer in the United States.

"This important development adds to the existing selection of safe and effective sunscreen filters currently on the market, giving consumers even greater choice in what works best for them. It also reflects years of scientific review, industry engagement, and regulatory efforts to modernize the OTC framework, including enactment of the Safe Sunscreen Innovation Act and subsequent reforms under OMUFA. CHPA appreciates FDA's continued commitment to advancing a more predictable monograph system and hopes this action signals continued progress toward bringing even more safe, effective, and science-backed OTC innovations to U.S. consumers."

Background:

BEMT is a broad-spectrum UV filter already widely used in global sunscreen formulations. Experts have noted that the ingredient may help expand formulation flexibility for sunscreen products, including lighter formulations that can support regular sunscreen use. The addition of BEMT to the list of sunscreen active ingredients expands the range of sunscreen options available to consumers while complementing the many safe and effective sunscreen ingredients already available in the U.S. marketplace.

For more information about BEMT, visit CHPA's Health In Hand Foundation's Consumer FAQ article.

The Consumer Healthcare Products Association (CHPA), founded in 1881, is the national trade association representing the leading manufacturers and marketers of consumer healthcare products, including over-the-counter (OTC) medicines, dietary supplements, and OTC medical devices. CHPA is committed to empowering self-care by ensuring that Americans have access to products they can count on to be reliable, affordable, and convenient, while also delivering new and better ways to get and stay healthy. Visit www.chpa.org.