FDA Clears Bemotrizinol for U.S. Sunscreens After 20-Year Review, First New Ingredient Since 1999

U.S. market in more than 25 years. The agency determined that the ingredient meets its standards for protection against ultraviolet rays while producing little irritation or absorption into the skin.

It is considered generally recognized as safe and effective for adults and children six months and older. Bemotrizinol will be sold initially by DSM Nutritional Products under the brand name Parsol Shield. The product is expected to launch later this year, and other manufacturers may use the ingredient after an 18-month exclusivity period.

The final order takes effect on Aug. 9. The FDA will finalize the order on Wednesday. DSM Nutritional Products submitted a request last year to add bemotrizinol at concentrations up to 6 percent to the over-the-counter sunscreen monograph.

The FDA proposed the addition in December. Studies submitted by DSM showed that repeat exposure to bemotrizinol did not cause irritation or elicit a sensitization, photo-allergenic, or phototoxicity response. Two independent human clinical efficacy studies supported its effectiveness.

Bemotrizinol provides protection against both ultraviolet A and B rays and has low levels of absorption through the skin. European authorities authorized the ingredient in 1999, and it was first filed with the FDA for review in 2005. All sunscreens sold in the United States must protect against UVB rays, which cause most sunburn, and UVA rays, which pose the greatest risk of skin cancer and wrinkles.

Currently available chemical ingredients protect against only one type, while mineral ingredients such as zinc oxide block both but leave a chalky white residue. The FDA banned the term “waterproof” in 2011 and required all sunscreens to filter both UVA and UVB rays. In 2021 the agency proposed additional measures including capping SPF numbers and requiring stronger UVA protection.

U.S. Health and Human Services Secretary Robert F. Kennedy Jr. stated 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.

Dr. Mike Davis, acting director of the FDA’s Center for Drug Evaluation and Research, stated that the FDA is committed to ensuring American consumers have access to the most effective and safe therapies, including over-the-counter products like sunscreens.

The FDA recommends applying sunscreen 15 minutes before exposure, covering the entire face and body except the eyes and mouth, and reapplying at least every two hours or more often if swimming or sweating.