For more than two decades, US sunscreen manufacturers have been frozen in time, forced to watch their European and Asian counterparts innovate by using advanced UV filters not permitted in the US. Today, the U.S. Food and Drug Administration (FDA) took its first step to remedy that innovation gap by approving bemotrizinol, the first UV filter to be added to the sunscreen monograph since the late 1990s.
Sunscreen is regulated in the US as an over-the-counter drug, which means that for a new UV filter to be approved, it must undergo the lengthy and expensive process of being added to the monograph—unlike almost everywhere else in the world, where sunscreen is regulated as a cosmetic. The oil-soluble organic UV filter was first developed by Ciba Specialty Chemicals in the late 1990s. In 2008, BASF acquired Ciba and took over development and manufacturing, but the chemical giant didn’t want to invest the time and money required to secure US regulatory approval for the UV filter. In 2018, DSM (now dsm-firmenich) became the sole sponsor of bemotrizinol, which the company rebranded as Parsol Shield. By ushering the UV filter through the cumbersome FDA monograph process, the beauty and nutrition conglomerate earned an 18-month exclusive in the US.
If anyone can take a bow for today, it would be Carl D’Ruiz, Senior Manager of Beauty & Care Science, Advocacy & Business Development in North America for dsm-firmenich. D’Ruiz has been part of this arduous process since he was at Ciba in the 1990s. He then joined DSM in 2018 to lead efforts to secure FDA approval for bemotrizinol. When D’Ruiz spoke to BeautyMatter late last year, he recognized the impact of this historic milestone. “And here we are now, something that hasn't happened for more than one generation, right? An entire generation of people haven’t been exposed to new ingredients. So finally, we have a new, old ingredient on the monograph.”
Unlike traditional chemical filters used in the US, which often need to be combined to achieve broad-spectrum protection, bemotrizinol absorbs UVB, UVA2, and UVA1 rays on its own.
The compound is also known for stabilizing less-stable UV filters and for remaining effective after prolonged UV exposure. Its large molecular size, which results in minimal skin absorption, contributes to its strong photostability and low sensitization potential.
The addition has been long-awaited in the US, as Australia, Japan, South Korea, and countries across Europe have used the filter for years. The FDA considers bemotrizinol to be Generally Recognized as Safe and Effective (GRASE) for use in sunscreen products intended for adults and children six months of age and older. The ingredient may be used in concentrations of up to 6%.
“This is exactly the kind of progress we can achieve when we modernize our processes and apply sound science to regulatory decisions,” said Mike Davis, MD, PhD, Acting Director of the FDA Center for Drug Evaluation and Research (CDER), in a press release. “The FDA is committed to ensuring the American consumer has access to the most effective and safe therapies, including over-the-counter products like sunscreens.”
Bemotrizinol is the first new active ingredient added to an OTC monograph under the streamlined process established by the CARES Act. The legislation was designed to improve regulatory processes for over-the-counter sunscreens and other products to help ensure that the US’ framework remains aligned with the standards of other leading nations.
“The FDA’s rigorous standards ensure consumers can be confident in the sunscreens and other nonprescription drugs they use,” said Karen Murry, MD, Director of the Office of Nonprescription Drugs in CDER, in the press release. “Now, through the best available science and updated regulatory framework, we can work with companies to get innovative products to market in a more efficient manner than ever before.”