FDA now weighing approval of first new sunscreen ingredient in decades

The Food and Drug Administration is now weighing whether to approve the first new sunscreen ingredient for the U.S. market in decades, European skincare company DSM-Firmenich announced this week.

DSM-Firmenich says the FDA is expected to decide within the next 17.5 months  — by March 2026 — on the company’s request to approve the sunscreen ingredient bemotrizinol, branded as PARSOL Shield. 

“PARSOL Shield has been safely used worldwide for over 20 years, and we are proud to lead the introduction of this proven technology to U.S. consumers,” Parand Salmassinia, president of beauty and care at DSM-Firmenich, said in a release.

If the FDA agrees with DSM-Firmenich’s request, the next step will be for the FDA to propose adding bemotrizinol to the list of over-the-counter drugs that are “generally recognized as safe and effective” to be sold to Americans. The public will have an opportunity to comment on the addition, the FDA said, before the ingredient is finally cleared for use.

The company began running a new round of studies on the ingredient requested by the FDA in 2019, Carl D’Ruiz, senior regulatory and business development manager for DSM-Firmenich, told CBS News. 

News of the potential approval comes as the FDA is demanding more research into many sunscreen ingredients currently on the U.S. market, over safety questions. 

The FDA has also been facing criticism from members of Congress, frustrated with the gulf between the U.S. market versus the newer sunscreen options now available abroad.

A sunscreen ingredient widely used overseas

While bemotrizinol would be new for the U.S. market, D’Ruiz said brands in other countries have been using it for decades. Under other names like BEMT or Tinosorb S, many sunscreens bought in Japan, South Korea and across Europe use the chemical.

Manufacturers can make formulations with bemotrizinol that are “less pasty” and look better on people of color, compared to some older options.

“Consumers are purchasing products with bemotrizinol when they go abroad, simply because they feel good, look good, and like the way it goes on the skin,” he said.

Bemotrizinol will also be the first to study all the safety questions outlined by the FDA’s stepped-up standards on sunscreen risks, D’Ruiz said.

“No other ingredient is going to have the same level of substantiation for safety, especially long-term safety, and developmental and reproductive safety,” said D’Ruiz.

It also comes as DSM-Firmenich and others in the industry have been lobbying Congress over changes they think could make it easier to bring more sunscreen ingredients to the U.S. that could be popular with Americans, potentially resulting in higher sales of sunscreen products and less skin cancer.

One gripe comes down to the economics of clearing the FDA’s hurdles, D’Ruiz said, which will only afford companies 18 months of “exclusivity” for selling the ingredient.

“The return on the investment is just not there. Maybe nobody is going to want to do this again. And that’s going to jeopardize public health,” he said.

Safety of current sunscreens

An FDA proposal from 2019 floated pulling the approvals for more than a dozen sunscreen ingredients. Only two sunscreen ingredients — zinc oxide and titanium dioxide — would be able to keep their decades-old approvals under that proposal.

For most of the others, the FDA said there were “significant gaps” in evidence of their safety. Studies had raised questions about whether “significant systemic exposure” to those ingredients might lead to health issues. More research was needed to rule out long-term risks like cancer or hormone disruption.

Addressing those concerns would require the industry to do more animal testing, similar to studies routinely required for other kinds of drugs, the FDA said. 

Animal rights groups and lawmakers have criticized the FDA for insisting that the industry run animal testing on the sunscreens. But developing alternatives to animal testing would take “years and years,” the FDA said — too late for a decision it hoped to make “in the near future.”

An FDA spokesperson said Wednesday the agency is still waiting for data to confirm that the ingredients are all safe and effective.

“The FDA continues to encourage industry to submit data to address the data gaps for those,” Cherie Duvall-Jones, the FDA spokesperson, said in a statement.

Records the FDA released from meetings last year with an industry trade group, the Personal Care Products Council, or PCPC, show federal officials were frustrated with a lack of progress.

A representative for Integral Consulting, which took over the sunscreen industry working group from PCPC, declined to comment.

“During the comment summary, PCPC stated sunscreen ingredients are safe. In response, FDA stated the safety of sunscreens has not yet been established,” the agency said last year, in minutes from the meeting.