The US Food and Drug Administration may be adding new regulations to over-the-counter sun protection products.
The public can review and comment on the new regulations, which were announced Thursday, for 90 days. The proposal discusses the safety of sunscreen ingredients, their dosage forms, sun protection factor (SPF), protection requirements, and labeling.
“Since the initial evaluation of these products, we know much more about the effects of the sun and about sunscreen absorption through the skin,” said the FDA Commissioner, Dr. Scott Gottlieb.
According to the Sunscreen Innovation Act, the FDA is to monitor all over-the-counter sunscreen drug products.
However, the proposed regulations will give some formulas and ingredients the ability to be marketed without new drug approvals. This would include ingredients like zinc oxide, titanium oxide, and sunscreens sold in a variety of ways.
PABA and trolamine salicylate would not be on the list of approved ingredients, and any products with these ingredients would need to go through the FDA approval process.
Due to recent issues with ingredients in certain personal care products, there will be additional scrutiny of these products as well. Powders, wipes, towelettes, body washes, and shampoos will 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,” says Dr. Henry Lim, a past president of the American Academy of Dermatology.
“We are quite comfortable with the types of sunscreens that we have in the United States at this time,” he says.
Lim is concerned that the new measures will make it harder for new sunscreens, specifically those made outside of the United States, to be approved for use.
In addition to cracking down on ingredients, the new proposal raises the maximum SPF from 50+ to 60+. Any products rated as SPF 15 or greater will need to provide protection against UVA and UVB rays.
Companies would also need to accurately label their products with the active ingredients on the front of the packaging. SPF and water-resistant statements would also need to be clearly stated.
The FDA wants your opinion on these new measures.
“We will continue to work with industry, consumers and public health stakeholders to ensure that we’re striking the right balance,” said Gottlieb.