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FDA Releases Final Sunscreen Monograph

Posted: June 16, 2011

After nearly a four year wait, the U.S. Food and Drug Administration (FDA) has issued its Final Sunscreen Monograph, which addresses the testing and labeling of over-the-counter (OTC) sunscreen products.

In addition to its monograph, the FDA also published a Draft Enforcement Guidance for Industry document, further explaining the final rule, a Proposed Rule on sunscreens with SPFs greater than 50, and an Advance Notice of Proposed Rulemaking (ANPR) recognizing and requesting information about alternative dosage forms of sunscreen products such as sprays, powders, wipes and shampoos.

The final rule requires a Broad-spectrum Test Procedure, which tests a product's UVA protection relative to its UVB protection, before a "Broad-spectrum SPF [Value]" claim can be printed on the product's label. Manufacturers that do not conduct this test cannot use the claim.

In addition, products with a protection of broad-spectrum SPF15 or higher can claim to reduce the risk of skin cancer or early aging if used as directed. Non broad-spectrum sunscreens and broad- spectrum sunscreens with an SPF value between 2 and 14 can only claim to help prevent sunburn.

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 immediate sun protection without submitting data to support these claims and obtaining FDA approval. Manufacturers, however, can claim "water-resistant" by labeling the front of the product with a 40 minute or 80 minute protection 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.

Finally, all sunscreens are required to include standard "Drug Facts" information on the back and/or side of the container.

In its final rule, the FDA found no safety issues with any sunscreen actives, including nano-sized titanium dioxide and zinc oxide.

If the FDA's proposed document is approved, the SPF value on sunscreen labels would be limited to SPF 50, as the FDA noted that there is not sufficient data to show that SPF 50+ sunscreens provide greater protection for consumers than products SPF 50. This proposed regulation is available for public comment. Those wishing to claim SPFs 50+ must submit independent clinical test support that is validated and repeatable. They may also provide additional data to support their SPF 50+ protection.

While the Personal Care Products Council was elated that the FDA published its final monograph, it expressed concern regarding the compliance deadline.The compliance date for all sunscreen manufacturers is June 18, 2012, with the exception of manufacturers with annual sales less than $25,000, who must comply by June 17, 2013.

“We are evaluating FDA’s specified implementation period, but we are concerned about manufacturers’ ability to make the required testing and labeling changes in only 12 months given the thousands of products on the market, the limited number of testing facilities, and the time needed to redesign product labeling. It is unusual for FDA to require such a short implementation period for a rule making of this scope. Manufacturers typically require at least two years to design and implement broad-scale, product-wide labeling changes," noted Farah Ahmed, the chair for the sunscreen task force of the PCPC, in a press release by the organization.

One thing is clear—manufacturers of sun care products in the United States no longer have to wait and can now move forward in formulating sun care products with innovative to provide the consumer with more effective sun protection options.