Editor’s note: On June 9, 2026, the U.S. Food and Drug Administration (FDA) announced the addition of bemotrizinol (BEMT) to its list of permitted sunscreen active ingredients. This marks the first new ingredient added to the over-the-counter sunscreen monograph since the 1990s.
Bemotrizinol has been used as a sunscreen ingredient in Europe and many other regions around the world for years. The proposal for FDA approval was submitted by dsm-firmenich, under the tradename PARSOL Shield.
Carl D’Ruiz, senior manager of North America Beauty & Care Advocacy and Business Development at dsm-firmenich, played a significant role in the approval. He has been a staunch advocate for enhanced sun protection regulations, and he has been rooting for BEMT for many years.
Cosmetics & Toiletries asked D’Ruiz to share his story about BEMT and what this monumental approval means not only to him, but to the industry as a whole.
My journey with BEMT actually began more than 25 years ago. In the late 1990s, while working at Ciba Specialty Chemicals, the original inventor of the molecule, I was involved in supporting the studies and regulatory activities that led to its approval in Europe and subsequently around the world. I also participated in the effort to bring BEMT to the United States through the FDA's Time and Extent Application (TEA) process, which was initiated in 2005.
From the beginning, BEMT stood out as a truly innovative UV filter. Its broad-spectrum protection, excellent photostability and extensive global safety record made it a significant advancement in sun protection technology. Yet despite its successful adoption across global markets, it remained unavailable to American consumers for many years.
In many ways, my joining dsm-firmenich in 2018 represented a continuation of a mission that had started more than a decade earlier. One of the company's goals was to obtain FDA approval for BEMT and finally complete the work that had begun with the TEA submission in 2005. The opportunity to help finish that journey was both professionally exciting and personally meaningful.
The FDA approval process for BEMT (PARSOL Shield) proved to be a long and complex endeavor. Shortly after joining dsm-firmenich, we engaged with the FDA to obtain alignment on the regulatory path forward after reviewing prior agency correspondence and findings associated with the TEA. At that time, the anticipated approval pathway involved filing an Investigational New Drug (IND) application under the Sunscreen Innovation Act.
However, the landscape changed significantly with the passage of the CARES Act in 2020, which included FDA OTC drug reform provisions and introduced a new fee-based pathway for sunscreen active ingredients through a Tier 1 OTC Monograph Order Request (OMOR). As a result, much of the IND package that had been assembled had to be restructured and reformatted to meet the new OMOR requirements. This was an unexpected and time-consuming challenge for the team.
The timing also coincided with the COVID-19 pandemic, which made conducting the required clinical studies, including Maximum Usage Trials (MUsT), especially difficult. The data package we generated was designed around the FDA's most recent 2016 and 2018 guidance recommendations, and every major study protocol required review and agreement with the agency before execution. Those discussions were rigorous and often lengthy, but they ultimately helped ensure that the data package would meet FDA expectations.
One of the most rewarding aspects of the journey was collaborating with a broad community of scientists, dermatologists, formulators, toxicologists, and regulatory experts. We spent considerable time sharing the science behind BEMT and discussing the benefits of modern UV-filter technology. Given BEMT's established history of safe use around the world, there was strong interest in finally making this innovation available to U.S. consumers.
The "eureka" moments came not from a single breakthrough, but from the steady accumulation of achievements along the way. Successfully completing the required studies, securing alignment on protocols, adapting to changing regulations, and navigating nearly a year of detailed FDA information requests all reinforced our confidence that the science would ultimately prevail.
That moment finally arrived in June of this year when the FDA issued a Final Order determining that PARSOL Shield (BEMT) is GRASE—Generally Recognized as Safe and Effective. For everyone involved, it was an extraordinary milestone. It represented the first approval of a new UV filter in the United States since 1999 and opened the door for the introduction of more advanced sunscreen technologies that have been available globally for many years.
Looking ahead, the next step is enabling sunscreen manufacturers to incorporate PARSOL Shield into innovative formulations that don’t currently exist in the US and bring those products to market. We are excited about the opportunity to provide consumers with access to more advanced sun protection options and help support improved skin cancer prevention and public health outcomes.
Reflecting on the experience, it truly has been an epic journey. Few professional opportunities allow someone to be involved at the inception of a technology, contribute to its development over decades, and ultimately help bring it to regulatory approval. From supporting BEMT's original registrations at Ciba Specialty Chemicals to helping lead the FDA approval effort at dsm-firmenich, I have been fortunate to witness the full arc of its story.
What I will remember most, however, is the people. This achievement was only possible because of the dedication, expertise, and perseverance of colleagues across dsm-firmenich and around the world. Scientists, regulatory experts, clinical teams, toxicologists, formulators, commercial leaders, and many others worked tirelessly over many years through changing regulatory landscapes, a global pandemic, and numerous unexpected challenges. Their commitment never wavered.
I am deeply grateful to have been part of such an exceptional team and to work for a company that had the vision and courage to invest in long-term innovation when the path forward was far from certain. The FDA's Final Order declaring PARSOL Shield (BEMT) GRASE is a remarkable milestone—not just for our company, but for public health and sunscreen innovation in the United States. More than anything, it stands as a testament to what can be accomplished when talented people unite around a common purpose and refuse to give up.
