TAMPA, Fla. (FOX 13) - The FDA says sunscreen companies need to provide proof that the ingredients in their products actually protect users from the sun’s harmful rays, and that level of protection needs to be clearly communicated on the labels of products sold in stores.
The Food and Drug Administration has proposed new regulations that could mean sweeping changes for the sunscreen industry and how products are labeled, and the dosages and ingredients they contain.
The FDA is asking sunscreen manufacturers to produce scientific data regarding the safety and effectiveness of their ingredients – and that the products perform as claimed.
There are 16 ingredients the FDA is considering under the new regulations.
First, the FDA says two ingredients sometimes found in sunscreens – PABA and trolamine salicylate – are not safe and should no longer be used.
Second, the FDA says two ingredients commonly found in sunscreens – zinc oxide and titanium dioxide - are safe and may continue to be used.
As for the 12 remaining ingredients, the FDA is not saying they are unsafe, but instead are saying more information is needed about their safety for use on humans.
Every drug has active ingredients and inactive ingredients. In the case of sunscreen, active ingredients are the ones that are protecting your skin from the sun’s harmful UV rays. Inactive ingredients are all other ingredients, such as water or oil, that may be used in formulating sunscreens. Below is the list of 12 active ingredients in products that are labeled as sunscreen, on which the FDA now wants companies to perform further research.
- Aminobenzoic acid
- Padimate O
- Titanium dioxide
- Trolamine salicylate
- Zinc oxide
Also included in the new rules is a requirement that sunscreens with an SPF of 15 or higher should have broad-spectrum protection, meaning it would protect against UVA and UVB rays. The products would also have to prove that UVA protection increases as its SPF increases.
“These proposals are designed to ensure that these products provide consumers with the protections that they expect,” the FDA wrote in a press release about the new regulations.
The FDA also said sunscreen product labels would need to prominently display information about the active ingredients on the front of the package, just like other over the counter medications.
The new regulations will apply to sunscreen sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks.
The FDA has given sunscreen manufacturers 90 days to submit the required information.
The FDA says as this process moves forward, over the counter sunscreen products will still be available for consumer use. The agency says to continue using broad-spectrum sunscreen with SPF of 15 or higher, along with other sun protective measures.