The FDA has finally released their long awaited, updated sunscreen regulations. Though the new regs are a bit less comprehensive with regards to UVA protection than many had expected, they should begin to bring many sunscreen label claims back down to earth. Companies were originally required to comply by summer 2012, though the FDA has just extended this to year’s end 2012. This will help consumers ensure they are getting better UVA and UVB, ‘Broad Spectrum’ protection.
The FDA made final a number of standards, while proposing a cap of the SPF number at “50+” and reviewing the efficacy of sunscreen sprays. The large body of data does not demonstrate the SPF numbers higher than 50 provide anymore benefit than an actual SPF 50. Furthermore, an SPF 50 only provides 1% more protection than an SPF 30 and many experts question whether or not that extra 1% can truly be demonstrated outside of the testing environment. As far as the sprays are concerned, the current data indicates considerable discrepancies with regards to dosages and efficacy in comparison to that of lotions, creams, sticks, etc. The FDA had taken public comments on these proposals through September 15th, 2012. The FDA will eventually determine the time of review and the fait of the SPF number and spray sunscreens.
The new final label regulations and sunscreen standards for 2013 and beyond, as published by the FDA, look like this:
Broad Spectrum Protection. Sunscreens that pass FDA’s broad spectrum test procedure, which measures a product’s UVA protection relative to its UVB protection by way of the Critical Wave Length Test, may be labeled as “Broad Spectrum SPF [value]” on the front label. For Broad Spectrum sunscreens, SPF values also indicate the amount or magnitude 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 Broad Spectrum sunscreens with an SPF value of 15 or higher can claim to reduce the risk 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, “sweatproof” or “sunblock” claims. Manufacturers cannot label sunscreens as “waterproof” or “sweatproof,” or identify their products as “sunblocks,” 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 Resistant claims. Water resistance claims on the front label must indicate whether the sunscreen remains effective 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 sunscreens must include standard “Drug Facts” information on the back and/or side of the container.