- Bemotrizinol is the first new FDA-approved sunscreen active ingredient in over 25 years.
- Skin cancer is largely preventable with adequate sun protection methods.
- Regulatory changes aim to streamline the U.S. approval process.
It’s not often that the top U.S. health boss shows up to talk about approval of an active ingredient, but that’s exactly what Health and Human Services Secretary Robert F. Kennedy Jr. did this week.
The U.S. Food and Drug Administration added bemotrizinol to its list of active ingredients that are approved for sunscreen, calling it a “significant milestone” since it’s “the first new active ingredient added to the over-the-counter sunscreen monograph since the late 1990s,” per the FDA announcement.
“As promised in the Trump administration’s MAHA Strategy Report, HHS is advancing innovation by bringing a new sunscreen ingredient to the U.S. market for the first time in 20 years,” Kennedy said in the release. “Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products.”
The Skin Cancer Foundation’s president, Dr. Deborah S. Sarnoff, hailed the decision in an email to media, also noting the dearth of new ingredients in decades. She said consumers will be able to buy sunscreen based on bemotrizinol soon, under the brand name PARSOL Shield.
Bemotrizinol screens out ultraviolet A and B rays but allows only low levels of absorption through the skin into the body. It’s classified as GRASE — “generally recognized as safe and effective” in sunscreens for those 6 months and older.
About skin cancer
Skin cancer is the most common cancer in America, with the vast majority of cases (90%) associated with exposure to ultraviolet radiation. That makes it largely preventible if people take steps to protect themselves from the sun’s rays, which can reach skin even on cloudy days.
According to the foundation, while American consumers already have access to many sunscreen filters, expanding the range of available ingredients can help improve sunscreen formulation options and encourage greater daily use. People are more likely to use sun protection consistently when they can find products that meet their individual needs and preferences. Additional sunscreen options can help make daily sun protection more accessible and appeal to a broader range of consumers.
The foundation also offers other tips in addition to sunscreen with a minimum of SPF 30, including seeking shade, wearing long sleeves or pants and hats to protect skin, and UV-blocking sunglasses. For long exposures outdoors, people are reminded to choose a broad-spectrum, water-resistant sunscreen with SPF 50 or higher.
Changing the approval process
The CARES Act established a “streamlined process,” in line, the FDA said, with the Make American Healthy Again strategy: “FDA will promote innovation in the sunscreen market, and improve regulatory processes for over-the-counter sunscreen, which has fallen behind other countries.”
The FDA said an over-the-counter monograph drug, like this sunscreen product, can enter the market without going through the drug approval process if it meets certain requirements, “including conditions established in its monograph such as permitted active ingredients, uses and doses. The FDA can modify an OTC monograph through an administrative order and a drug company may start the process by submitting an OTC monograph order request.”
That’s what DSM Nutritional Products LLC did for bemotrizinol, in up to 6% concentration, to be the active ingredient in sunscreens. In December, the FDA issued a proposed order and took public comments before issuing its final rule this week.