FDA proposes new sunscreen regulations

Posted at 4:13 PM, Feb 21, 2019

The US Food and Drug Administration is proposing new regulations on over-the-counter sunscreens in an effort to keep up with the latest scientific and safety information.

The proposal, announced Thursday, is available for public review and comment for the next 90 days and addresses the safety of common sunscreen ingredients, as well their dosage forms, sun protection factor (SPF) and broad-spectrum requirements. It also addresses labeling, aiming to make it easier for consumers to identify key product information.

"Since the initial evaluation of these products, we know much more about the effects of the sun and about sunscreen's absorption through the skin," FDA Commissioner Dr. Scott Gottlieb said in a statement.

Over-the-counter sunscreen drug products are regulated by the FDA under the Sunscreen Innovation Ac t, an expedited process put in place in 2014. Certain ingredients can be marketed without going through the new drug application process because they are generally considered to be safe.

Keep using sunscreen, experts advise

The proposed regulation would allow for some ingredients and formulations to continue to be marketed without new drug approvals, including zinc oxide, titanium oxide and sunscreens sold as sprays, oils, lotions, creams, gels, butters, pastes, ointment and sticks.

Two ingredients -- PABA and trolamine salicylate -- would not be on the list of ingredients generally recognized as safe and effective, and any product containing these would be considered a new drug and would have to be approved by the FDA before it is marketed.

For another list of 12 ingredients, the agency said there is insufficient data to decide on safety and appropriate regulation; as such, it has asked the sunscreen industry to conduct additional testing.

The agency has also asked the industry for additional testing on powders and noted that wipes, towelettes, body washes, shampoos and other dosage forms would be considered new drugs and have to go through the approval process.

The ingredients for which the FDA is asking for additional safety data have been around and in use in the United States for at least 20 years, said Dr. Henry Lim, immediate past president of the American Academy of Dermatology and a dermatologist at Henry Ford Hospital in Detroit. He said he applauds the FDA's efforts to collect additional safety data for some of them but does not want people to stop wearing sunscreen over safety concerns.

"We are quite comfortable with the types of sunscreens that we have in the United States at this time," he said.

Lim also worries that the proposed regulation would make it difficult for sunscreen ingredients available in other parts of the world to be approved in the United States, as companies may not be willing to conduct the required testing.

Environmental advocates praised the proposal.

"For a decade, EWG has worked to raise concerns about sunscreens with oxybenzone," said David Andrews, a senior scientist at the Environmental Working Group, an environmental advocacy nonprofit. "Today, the FDA recognized those concerns and said oxybenzone and 13 other ingredients are not classified as safe and effective for use."

SPF value and spectrum of protection

The proposal also addresses sunscreens' SPF and broad-spectrum coverage.

It would raise the maximum SPF labeling on products from 50+ to 60+, based on new evidence of some clinical benefits of additional SPF.

The regulation would also require all products labeled with an SPF of 15 or greater to offer broad-spectrum protection against UVA rays, typically associated with premature aging of the skin, and UVB rays, associated with skin cancers and sunburns.

The American Academy of Dermatology recommends picking products that are water-resistant, with broad-spectrum protection and SPF of at least 30.

Product labeling

The proposed regulation would also require sunscreen manufacturers to clearly label their products with active ingredients on the front, as well as more clear formats for SPF, broad-spectrum and water-resistant statements.

Sunscreens currently manufactured with insect repellents would also be considered new drugs.

The FDA is seeking comment from the public. "We will continue to work with industry, consumers and public health stakeholders to ensure that we're striking the right balance," Gottlieb said.