Summer is definitely here and most likely you have already made at least one trip to the store to purchase sunscreen. On your trip you may have found yourself a little overwhelmed by the variety of sunscreens available – waterproof, water resistant, sweatproof, broad spectrum, sun protection factors (SPFs) from 8 to 75+, sprays, lotions, gels, sticks, towelettes. Well the Food and Drug Administration (“FDA”) is trying to help consumers make more informed choices when it comes to sunscreens.  On June 14, the FDA published new rules and corresponding guidance regarding over the counter (OTC) sunscreen labeling and testing (collectively the “New Rules”). The New Rules, which are designed to give consumers more information on which sunscreen products offer the greatest protection, go into effect June 18, 2012, and govern how sunscreen is marketed. The prior sunscreen rules focused primarily on protection against ultraviolet B (“UVB”) radiation from the sun (these are the rays that cause sunburns), but did not address ultraviolet A (“UVA”) radiation, which can cause premature aging and skin cancer.  The key provisions of the New Rules include the following:

  • “Broad Spectrum” designation: Sunscreens that pass the FDA’s “broad spectrum” test procedure, which measures UVA protection relative to its UVB protection, may be labeled as “Broad Spectrum SPF [value]” on the front label. To pass the broad spectrum test, which is outlined in 21 CFR 201.327(j), the amount of UVA protection must increase as the SPF value increases. The New Rules also modify the existing SPF test.
  • Use claims: Only Broad Spectrum sunscreens with an SPF value of 15 or higher can claim additional benefits – such as, reduces the risk of skin cancer and early aging if used as directed with other sun protection measures (such as limiting time in the sun and wearing protective clothing). Non-Broad Spectrum and Broad Spectrum sunscreens with an SPF of between 2 and 14 may only claim to help prevent sunburn and must include the warning “Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging."
  • Prohibition of “waterproof,” “sweatproof” and “sunblock” claims: These claims are prohibited because the FDA’s research showed that such claims overstate effectiveness. Sunscreens also cannot claim to provide sun protection for more than two hours without reapplication or to provide protection immediately after application, without submitting data to the FDA and obtaining approval.
  • Water Resistance claims: The New Rules establish testing for water resistance and require manufacturers to indicate on the front label whether the sunscreen remains effective for up to 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 sunscreen must include standard drug facts on the back or side of the container. 

In addition to the New Rules, the FDA published a proposed rule (“Proposed Rule”), an Advanced Notice of Proposed Rulemaking (“ANPR”) and guidance for the industry (the “Guidance”). The Propose Rule, if finalized, would limit the maximum SPF value to “50+” because the FDA has not seen sufficient data to show that products with SPF over 50 provide greater protection. The Proposed Rule is available for public comment until September 15, 2011. 

The ANPR requests additional data relating to sunscreen products in specific dosage forms (such as oils, creams, sprays, sticks, gels, butters, etc.) to further the understanding of how dosage forms affect safety and effectiveness.

The Guidelines set forth the FDA’s proposed enforcement policy for the OTC drug products marketed without an approved application. These guidelines are open for comment until mid-August.

Why is this important?  The FDA announced its intent to draft sunscreen rules in 1978 and published rules in 1999.  The agency then put the implementation of the 1999 rules on indefinite hold until it could address both UVB and UVA radiation. Then in 2007, the agency published a proposed rule that addressed SPF testing and labeling, but still did not lift the stay on the 1999 rule. Although many sunscreen manufacturers may already follow the proposed guidelines set forth in 2007, it is doubtful that implementation of the New Rules will be delayed – thus compliance will be required. The good news is that sunscreen manufacturers now have clearer guidance on testing. The bad news is that costs will be associated with compliance, including new testing and relabeling products. To ease the economic burden, the compliance date for all products with annual sales of less than $25,000 is June 13, 2013. For all other OTC sunscreen drug products without an approved application, the compliance date is June 18, 2012.