FDA makes major changes to OTC sunscreen requirements
Increased safety and efficacy and reduced confusion promised
The US FDA has announced changes to sunscreen products sold over the counter that it says will help consumers decide how to buy and use sunscreen as well as protect themselves more effectively from sun-induced damage.
Sunscreen products that meet modern standards for effectiveness may be labelled with new information to help consumers find products that, when used with other sun protection measures, reduce the risk of skin cancer and early skin ageing, as well as help prevent sunburn.
The FDA says the new requirements are part of an ongoing effort to ensure sunscreens meet modern standards for safety and efficacy and are based on the latest science available. “They will also reduce confusion about sunscreen,” adds the FDA.
The new requirements are outlined in four regulatory documents: a Final Rule, a Proposed Rule, an Advance Notice of Proposed Rulemaking and a Draft Guidance for Industry.
The requirements of the new final rule include:
Broad Spectrum designation: Sunscreens that pass FDA's broad spectrum test procedure, which measures a product's UVA protection relative to its UVB protection, may be labelled 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.
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 ageing 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 two hours without reapplication or to provide protection immediately after application (eg ‘instant protection’) without submitting data to support these claims and obtaining FDA approval.
Water resistance 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.