The changes to FDA regulations for sunscreen products

Under the Sunscreen Innovation Act, over the counter sunscreen products are regulated by the FDA. This means that certain ingredients are considered to be safe, and are allowed to be put on the market without going through an individual drug application.

However, due to new scientific evidence, the FDA is proposing new regulations on these products. In the next 90 days, there will be a public review of the proposal.

So, what are the proposals? And how will they affect the way sunscreen products are regulated in the future?

Sunscreen ingredients:

The first change to the regulations is which ingredients are included. They would allow certain ingredients to continue being used within the drug approvals, for instance, zinc oxide and titanium oxide.

However, products containing PABA and trolamine salicylate, which are usually considered to be safe to use, would need to seek FDA approval before being sold.

A further twelve ingredients are still being reviewed. The FDA say that, as there’s currently not enough information available, the sunscreen industry will need to conduct further tests into the safety of these ingredients.

Dosage forms:

Under the proposals, sunscreens that are sold as sunscreens sold as sprays, oils, lotions, creams, gels, butters, pastes, ointment, and sticks will still be covered by the regulations and will be allowed to be sold as usual.

But, other forms, like wipes, towelettes, body washes, and shampoo will need FDA approval. The agency added that products in powder form will need further testing to establish their safety.

SPF requirements:

Because of new research into the benefits of an SPF of more than 50, the maximum SPF on labels will now be 60+, instead of the current limit of 50+. It would also require products with and SPF of over 15 to provide additional UVA and UVB protection to consumers.

Clear labelling:

The new regulations would require changes to the labelling system in order to make it clearer for consumers looking for key product information. Manufacturers would need to display active ingredients on the front. They would also need to use a clear format to SPF information and other statements.