Many people rely on sunscreens to help prevent sunburn. Certain sunscreens are also used, along with other protective measures, to reduce the risks of skin cancer and early skin aging caused by the sun.
- The vast majority of sunscreens available are marketed under a regulatory framework called the OTC Monograph System. FDA reviews the active ingredients in these products to determine whether the ingredients are generally recognized as safe and effective (GRASE) for OTC sunscreen use.
- The Sunscreen Innovation Act recognized an alternative procedure for the assessment of safety and efficiency of additional active ingredients for use in sunscreens and set deadlines for reviewing the ingredients and taking certain other actions. But SIA did not eliminate the need for a GRASE determination for new sunscreen active ingredients before reaching the market without an approved marketing application, and it did not relax the scientific standards for these products.
- Since the SIA was passed, FDA has met all of the limits for executing this multipart legislation. That includes inviting public comment on our actions, holding requested meetings with industry, issuing draft and final guidance, issuing proposed and final rulemaking required to date.
- When the SIA was endorsed, eight sunscreen active ingredients were already under assessment. The FDA has issued proposed sunscreen orders identifying data we believe is necessary for the agency to make a positive GRASE determination on those within the SIA-required time frame, but has yet to receive the additional data we requested.
- Today, as required by the SIA, a final guidance document has been released that details the Agency’s current thinking on the specific information that is believed to be needed from sunscreen manufacturers or other interested parties before they can determine that a sunscreen active ingredient is GRASE for use in OTC sunscreens. This guidance will also help clarify FDA’s outstanding requests for additional safety and effectiveness data on the eight active ingredients, including the importance of human absorption data.
- Sunscreens are supposed to be used on a regular basis in liberal amounts and over large portions of the body surface whenever consumers are exposed to the sun. And yet some sunscreen active ingredients may be absorbed through the skin into the body, making it important to complete studies in humans to determine whether, and to what extent, consumers’ use of sunscreen products as directed may result in unintended, chronic, systemic exposure to these ingredients.
- The guidance mentions that industry provide data from a Maximal Usage Trial or Must, to help determine if the ingredient is absorbed into the blood and at what level. This type of study is designed to capture the effect of the maximal use on absorption into the blood.
- Sunscreens are a valuable tool for sun safety and public health, but of course, are not the only tool. Seeking shade during peak sunlight hours and wearing protective clothing, hats, and sunglasses are key to every sun protection plan. The sunscreen page on FDA’s website provides useful information for sun safety.
- The final guidance encourages industry to provide the FDA with the data they need, so that together they can help bring a wider assortment of safe and effective sunscreen products to the public.
Main points In FDA’s new sunscreen rules
- Broad Spectrum designation
Sunscreens that pass FDA’s broad-spectrum test procedure, which measures a product’s ultraviolet A (UVA) protection relative to its ultraviolet B (UVB) protection, may be labeled as “Broad Spectrum SPF [value]” on the front label. For Broad Spectrum sunscreens, SPF values also designate the amount or scale of overall protection. Broad Spectrum SPF products with SPF values higher than 15 provide greater protection and may claim additional uses, as described in the next bullet.
- Use claims
Only the Broad-Spectrum sunscreens that have an SPF value of 15 or higher can entitle to decrease the danger of skin cancer and early skin aging if used as directed with other sun protection measures. Non-Broad-Spectrum sunscreens and Broad-Spectrum sunscreens with an SPF value between 2 and 14 can only claim to help prevent sunburn.
- Waterproof, Sweat proof or Sun Block claims
Manufacturers are not supposed total their sunscreen lotions as Waterproof and Sweat proof or recognize their products as “Sun blocks,” because these claims overstate their effectiveness. Sunscreens also cannot claim to provide sun protection for more than 2 hours without reapplication or to provide protection immediately after application (for example– “instant protection”) without submitting data to support these claims and obtaining FDA approval.
- Water resistance claims
The water resistance claims that are publicized on the visible label must specify if the sunscreen lotion remains operative for 40 minutes or 80 minutes while swimming or sweating, based on standard testing. Sunscreens that are not water resistant must include a direction instructing consumers to use a water-resistant sunscreen if swimming or sweating.
- Drug Facts
All the sunscreens should include typical “Drug Facts” data on the back and/or side of the container.