WASHINGTON – On Tuesday, federal health officials announced the approval of the first new sunscreen ingredient in more than 25 years, opening the door for Americans to use a chemical that has been available in Europe and elsewhere for quite some time.
This new ingredient, called bemotriginol, is designed to be minimally irritating and is not well absorbed by the skin. It meets the FDA’s standards for protection against harmful ultraviolet rays, with the agency confirming it is safe for both adults and children older than six months.
The initial offering of bemotriginol will come from Dutch company DSM Nutritional Products, marketed under the name Parsol Shield, and it’s expected to hit the U.S. market later this year. After an 18-month exclusivity window, other manufacturers will be able to use the ingredient as well.
Historically, attempts to launch new sunscreen products have come to a standstill for decades, largely due to FDA regulations that have complicated the update process for over-the-counter drug ingredients. Bemotriginol marks the first ingredient to successfully navigate a streamlined approval process established by Congress in 2020.
Experts believe bemotriginol will effectively fill a crucial gap in the U.S. sunscreen market, as it protects against both UV A and B rays without leaving the white residue that often comes with mineral-based options.
“While the rest of the world has made progress, we’ve been stuck with outdated sun protection for quite a while now,” commented David Andrews from the Environmental Working Group. He believes the approval of bemotriginol will initiate much-needed change.
Andrews’ organization has been a long-time advocate for stricter sunscreen standards and has urged the FDA to allow new active ingredients to enter the market.
Current FDA guidelines stipulate that sunscreens must offer protection from UVB rays, the primary cause of sunburn, as well as UVA rays, which are linked to the risk of skin cancer and aging skin.
At present, available chemical sunscreens typically protect against one type or the other, prompting companies to blend different chemicals for “broad spectrum protection.” On the other hand, mineral-based options, like zinc oxide, do protect from both but often leave a noticeable white film on the skin.
Bemotriginol received its initial approval in Europe back in 1999 and was submitted for FDA review in 2005.
“The FDA is dedicated to ensuring that Americans have access to the safest and most effective products, including sunscreen,” stated Dr. Mike Davis, acting director of the FDA Center for Drugs.
The FDA is in the process of updating its sunscreen standards gradually. In 2011, the agency prohibited terms like “waterproof,” deemed misleading, and enforced that all sunscreens must provide protection against both UVA and UVB rays—some formulations previously only protected against UVB rays.
In 2021, the FDA suggested further measures, including setting caps on SPF ratings and increasing the requirement for UVA protection, though these have yet to be finalized.
