The US Food and Drug Administration (FDA) has added a new ingredient to the short list of sun filters that American sunscreens are allowed to contain. The ingredient is called bemotrizinol, and it is the first new active sunscreen ingredient permitted in the United States since 19991. ABC News described it as a first in more than 20 years2, while the Skin Cancer Foundation noted that the last addition came more than 25 years ago3.
Bemotrizinol is not new to the world. It has been approved in other countries2, and Europe, Canada, Australia and many Asian countries have used it for decades4. It is also known as BEMT or by the trade name Tinosorb S4, and the company dsm-firmenich markets it as PARSOL Shield1.
What happened
The FDA issued a final order adding bemotrizinol to the over-the-counter sunscreen monograph1. A monograph is a kind of rulebook: a non-prescription product such as a sunscreen can go on sale without a standard drug approval if it follows the monograph’s rules on allowed ingredients, uses and doses1.
Under the final order, sunscreen makers may use bemotrizinol at up to 6% of a product1. The agency said it considers the ingredient “generally recognized as safe and effective” (a status known as GRASE) for use by adults and children 6 months of age and older2.
The decision came within 7 months of a proposed order the FDA issued in December 20251. The process began when dsm-firmenich filed a formal request asking the agency to change the monograph. The FDA then proposed the change, reviewed public comments and issued the final order1. According to the FDA, it is the first new active ingredient added to the monograph under the CARES Act1, which set up a process designed to modernize how the FDA evaluates over-the-counter drug ingredients4.
What the ingredient does
Sunlight contains two main kinds of ultraviolet (UV) light that harm skin. UVB rays are the main cause of sunburn, and UVA rays contribute to premature skin aging; both are tied to a higher risk of skin cancer4. Bemotrizinol is a “broad-spectrum” filter, meaning it blocks both UVA and UVB4. Many sunscreen ingredients approved in the US protect against only one type, and most protect only against UVB, according to AIM at Skin Cancer Foundation, a patient group4.
Bemotrizinol is a non-mineral, chemical filter. ABC News reported that it is more stable than other UVA and UVB filters on the US market, meaning it breaks down less easily in the sun2. The FDA determined that it has low levels of absorption through the skin4.
That last point matters because of its status. Healio reported that bemotrizinol is the first chemical ingredient to be considered GRASE1. The only two other sunscreen ingredients with that status are zinc oxide and titanium dioxide, which are both mineral filters1.
What the decision does not show
This is a regulatory ruling about one ingredient. It is not a new study of finished sunscreens, and none of the sources describe new trials showing that products with bemotrizinol lower skin cancer rates compared with current products.
The absorption question is also less settled than it might sound. Dermatologists told ABC News that bemotrizinol is not absorbed into the bloodstream as easily as other UVA filters, but also that it is not clear whether absorption of other sunscreen ingredients has any harmful health effects2. In other words, lower absorption is a measured property, while what that means for health remains an open question.
Shoppers will not see the change right away. AIM at Skin Cancer Foundation noted that the approval does not mean bemotrizinol sunscreens are on shelves yet, because manufacturers need time to formulate products and bring them to market4. The group added that existing broad-spectrum products remain effective4. The Skin Cancer Foundation said consumers can expect the ingredient to appear under the PARSOL Shield name “in the near future”3, without giving a date.
Who is behind it and who backed it
The request to add the ingredient came from dsm-firmenich, the company that markets it1, so the maker stands to gain commercially from the decision. Some advocacy groups, such as the Environmental Working Group (EWG), had petitioned the FDA for years to approve it2.
Health and Human Services Secretary Robert F. Kennedy Jr. tied the decision to the administration’s health agenda:
“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.”
He added that bemotrizinol “has been used safely in Europe for decades” and that the FDA’s action “will increase competition and consumer confidence in sunscreen products”1. Karen Murry, director of the FDA’s Office of Nonprescription Drugs, said the updated framework lets the agency “work with companies to get innovative products to market in a more efficient manner than ever before”1.
David Andrews, chief science officer at EWG, called it “a great day for American consumers and everyone who has fought to improve sunscreen options and close the UVA protection gap in U.S. sunscreens”2.
Doctors quoted in coverage were also positive. Anthony Rossi, a Mohs surgeon (a skin cancer surgeon) at Memorial Sloan Kettering Cancer Center, told Healio that bemotrizinol appears to cause less skin irritation and allergic reaction than other chemical filters and is more stable in light1. Healio notes that Rossi is also the founder of a skincare company, Dr. Rossi Derm MD Skincare1.
How it fits the bigger picture
Skin cancer is the most common cancer in the United States, and nearly 90 percent of skin cancers are associated with UV exposure, according to the Skin Cancer Foundation3. Rossi told Healio that about one in five Americans will develop skin cancer in their lifetime and that nearly 23 people die from melanoma, the deadliest common skin cancer, every day1.
For years, US sunscreens have had fewer filters to choose from than products sold abroad. AIM at Skin Cancer Foundation said slow and complex US rules for new over-the-counter sunscreen ingredients created a gap between the protection available in the US and in other parts of the world4. The group argued that bemotrizinol’s strong UVA coverage addresses a real gap in the US market4.
Advocates also point to how sunscreen feels. The Skin Cancer Foundation said people use sun protection more consistently when they can find products that suit their needs and preferences3. AIM at Skin Cancer Foundation said newer filters may support lighter formulas that feel better on the skin, which people are more likely to use4. These are expectations from advocates, not results from studies of the new products.
What to watch next
- The first US products. Whether and when sunscreens containing bemotrizinol reach stores, and under which brands.
- More ingredients. AIM at Skin Cancer Foundation noted that many other sunscreen filters used around the world are still awaiting FDA approval4. This decision was the first to go through the newer review process4, so it may show how quickly others can follow.
- Absorption research. Whether further studies clarify the open question dermatologists raised about what, if anything, skin absorption of older sunscreen ingredients means for health2.
For now, the change is on paper: US sunscreen makers have one more filter they are allowed to use, a filter that much of the rest of the world has used for decades4.
