Key Takeaways:
Christmas came early for Carl D’Ruiz and dsm-firmenich on December 11, when the Food and Drug Administration announced that it had proposed adding bemotrizinol to the list of approved UV filters on the sunscreen monograph, the first to be recommended in the US since 1999. D’Ruiz, who is the Senior Manager of Beauty & Care Science, Advocacy & Business Development in North America for dsm-firmenich, expected the news on December 23, and was “completely blown away” by the early FDA announcement.
D’Ruiz told BeautyMatter he was flooded with congratulations, from industry leaders and members of Congress to scientists and trade groups. dsm-firmenich sponsored the FDA Tier 1 OTC Monograph Order Request (OMOR) for PARSOL® Shield, known by the drug name bemotrizinol (BEMT), and D’Ruiz has been working towards getting regulatory approval since the molecule’s introduction.
When D’Ruiz began his sunscreen odyssey in the late nineties, he had a lot less gray hair, and Bill Clinton was president of the United States. At the time, D’Ruiz was US Director, Regulatory Affairs, Product Safety and Products Stewardship for the company that developed bemotrizinol, Ciba Specialty Chemicals (acquired by BASF in 2008). He watched as the rest of the world quickly approved the oil-soluble UV filter, which was praised globally for its photostability, broad-spectrum UVA and UVB protection, and large molecule size (limited skin penetration), but he knew he had a long road ahead of him in the US.
A Sea of False Starts
As per the FDA’s requirements for submitting a Time and Extent Application (TEA), Ciba had to wait for bemotrizinol to be widely marketed and used for a period of five years globally. The company formally submitted the TEA (for the consideration of inclusion of a new ingredient into the OTC drug monograph) in April of 2005. The FDA reviewed the TEA, confirmed bemotrizinol was eligible, and requested more data from Ciba. The company quickly submitted the requested data and then… crickets.
According to D’Ruiz, Ciba wasn’t the only company to submit a TEA for bemotrizinol and later be ghosted by the FDA. “Eight other companies were in the same boat.” The problem was that there was no regulatory mechanism for the FDA to review this information, as mandated by the guidelines, D’Ruiz said. So the industry continued to wait. For years.
The companies who submitted the TEA applications joined together to ask Congress for their help in forcing the FDA to bring clarity to an opaque process. And hence commenced D’Ruiz’s first of many appearances in front of Congress over the years. “Initially, we told Congress it was unacceptable. We needed more certainty regarding what the FDA needed to get this done.” Congress listened and passed the Sunscreen Innovation Act (SIA) in 2014. The purpose of the SIA was to create an expedited FDA review process for new over‑the‑counter sunscreen active ingredients—addressing a backlog and promoting faster access to advanced sunscreen formulations. Prior to SIA, there were no FDA industry guidelines related to studies required to determine Generally Recognized as Safe and Effective (GRASE) or timelines for FDA to review and make regulatory determinations.
In 2016, the FDA announced new requirements for submitting a sunscreen ingredient for GRASE, and the sunscreen manufacturers balked at the lengthy clinical trials that would cost millions. “Nobody did anything because it was way too expensive,” D’Ruiz said.
So then once again… crickets. That was until 2018, when ingredient conglomerate DSM Nutritional Products (the company became dsm-firmenich in 2024 through a merger) decided to act as the sole sponsor for the OMOR for PARSOL® Shield’s inclusion in the sunscreen monograph.
D’Ruiz had been a consultant to DSM from 2016-2017. But in October 2018, the company brought on D’Ruiz full time, and his first item of business was getting a meeting with the FDA. “By the time we had our meeting with the FDA to indicate our support for sponsoring the inclusion of PARSOL Shield on the monograph, all the guidance regarding what was required to get a GRASE determination was in place. We offered an approach that would fill all the gaps previously communicated during the TEA and SIA review.” The FDA informed DSM they would need to also file an Investigational New Drug (IND) investigation first. D’Ruiz said to them, “So if we do this, then it will get approved, right?”
In May 2019, the FDA published the final Maximal Usage Trials (MUsT) Guidance for topical active ingredients, which included sunscreens. This guidance, “Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over‑The‑Counter Monograph: Study Elements and Considerations,” provides detailed recommendations on designing and conducting MUsT studies to assess systemic absorption of topical ingredients.
The FDA performed its own MUsT on a set of random over-the-counter sunscreen products in July–August 2018 to measure systemic absorption. The findings were published in JAMA in May 2019, in a paper titled “Effect of Sunscreen Application Under Maximal Use Conditions on Plasma Concentration of Sunscreen Active Ingredients.” Results indicated that several existing active ingredients were absorbed systemically, with plasma concentrations often exceeding the FDA's 0.5 ng/mL threshold for further safety evaluation.
DSM conducted the required study on BEMT and published its results. “We were confident BEMT would make it through the process because of its established long-term safety profile, which was substantiated by a set of robust safety studies,” D’Ruiz explained. “All we had to do was conduct the clinical trials supporting its safety and efficacy. The fact that it [BEMT] is a large molecule by itself was not the sole determining factor. It was the totality of scientific evidence that existed to support its long-term use and safety as an active ingredient.”
Once the company had published its results, it was time to go back to the FDA to present its findings. “We were like ‘OK, FDA, we're ready. Let's get this.’”
Well, not so fast.
In 2020, buried in Section 505G of the CARES Act—the economic relief package passed to lessen the financial impact of the pandemic—there was language outlining a new administrative order process to replace the old monograph rulemaking process. “The CARES Act reinvented the FDA in terms of the regulatory program for accepting new OTC monograph ingredients,” D’Ruiz explained. The FDA implemented the new fee-based OMOR program and sunsetted the Sunscreen Innovation Act—which meant once again DSM had work to do before leveling up.
But this work was more busy work than anything else. “By the time the CARES Act implemented FDA reform and the new OMUFA (Over-The-Counter Monograph Drug User Fee Program) fee-based OMOR Tier 1 regulatory process on approving new active ingredients, we had already completed our clinical studies under our IND,” D’Ruiz said. “Once the FDA provided the industry guidelines related to the format and structure of OMOR Tier 1 submissions, we basically had to dismantle our IND, which was provided to the FDA under what’s called the electronic common technical document (eCTD) pathway to create individual PDF files of the same information for submission to FDA under the newly created CDER NextGen Portal that was established under the CARES Act.”
To give you an idea of the scope of this endeavor, it took D’Ruiz and his team almost six months to complete it.
dsm-firmenich completed its testing and at long last submitted the first-ever OMOR Tier 1 application in September of 2024 and paid the $537,000 fee. Of course the fee was on top of the $8 million the company spent since 2018 on all the clinical trials. “It wasn't easy, but we met every challenge.”
Once the OMOR was submitted, the FDA was helpful in providing advice and recommendations on how best to proceed during the entire process, according to D’Ruiz. They also sent more than 25 information requests to dsm-firmenich, which consisted of over 150 specific technical questions that were raised during the OMOR review process. “It [the information requests] always came out on Friday afternoon, and they would say they needed it by Tuesday.” D’Ruiz and the dsm-firmenich team gave up every weekend for almost a year.
A Much-Needed “W”
In October of this year, dsm-firmenich met with the FDA for the final review meeting—the last meeting in the timeline of the OMOR process. “They were very excited. They told us they expected the proposed order to be issued on December 23 and any data pending would not impact the final order.”
So when D’Ruiz got the barrage of congratulatory calls on December 11, he immediately called the team at the FDA to thank them for all their work because “this really has been a collaborative effort,” D’Ruiz said with palpable emotion. “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.”
D’Ruiz credits dsm-firmenich for being the only company that “had the balls” to put in the blood, sweat, tears, and exorbitant amounts of money to get this accomplished. He praised all of the people in the company who worked late nights and through weekends for years on this. “Kudos to us. We did it, and all in the interest of public health and humanity.”
dsm-firmenich expects the final order to be implemented in June 2026. From that point, dsm-firmenich will be rewarded for all of its hard work and lost weekends with an 18-month exclusive on bemotrizinol, which the company branded PARSOL Shield.
But this won’t be the last you hear of D’Ruiz. Next year he intends to focus on researching how the company can position other ingredients that are widely used globally. “I want to take my learnings from this process and make them into a more practical approach in terms of risk assessment and looking at the different signals, and real-world data that can contribute to the increased innovation that will allow for further advances in public health.”
