New Requirements for Over-the-Counter (OTC) Sunscreens Marketed in the U.S.

June 14, 2011

Dear International Colleague:

I am writing to inform you about the U.S. Food and Drug Administration’s (US FDA) new requirements for over-the-counter (OTC) sunscreens marketed in the United States. In the United States, these products are regulated as pharmaceutical products and not as cosmetics or consumer products as they are in many other countries. These new requirements are one of our Agency’s ongoing efforts to ensure sunscreens meet modern-day standards for safety and effectiveness. The new requirements involve new labeling changes to help consumers identify products that, when used with other sun protection measures, reduce the risk of skin cancer and early skin aging, as well as help prevent sunburn. The new requirements, we believe, will give consumers the tools they need to make informed choices when selecting sunscreens.

The new requirements, as well as several proposed changes for future requirements, are outlined in four regulatory documents including (1) a Final Rule, (2) a Proposed Rule, (3) an Advanced Notice of Proposed Rulemaking (ANPR), and (4) a Draft Guidance for Industry. These regulations do not address the safety of sunscreen active ingredients at this time and do not specifically address other dosage forms.

• The Final Rule allows sunscreen products that are in compliance with US FDA’s requirements for protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays to be labeled as “Broad Spectrum.” Products that have SPF values between 2 and 14 may be labeled as Broad Spectrum if they pass the required test, but only products that are labeled both as Broad Spectrum, with SPF values of 15 or higher, may state that they reduce the risk of skin cancer and early skin aging, when used as directed. This new rule also bans the use of the term “sun block” and requires that these products all be called “sunscreens”.
• The Proposed Rule would limit the maximum SPF value on sunscreen labels to “50 +”, because we do not believe there is sufficient data to show that products with SPF values higher than 50 provide greater protection for users than products with SPF values of 50. The proposal creates the opportunity for the submission of data to support including higher SPF values in the final rule.
• The ANPR will allow the public a period of time to submit requested data addressing the effectiveness and the safety of sunscreen sprays and to comment on possible directions and warnings for sprays that the FDA may pursue in the future, among other issues regarding dosage forms for sunscreens.
• The Draft Enforcement Guidance for Industry outlines information to help sunscreen product manufacturers understand how to label and test their products in light of the new final rule and other regulatory initiatives.

To ensure that sunscreen products meet modern safety standards, FDA is also currently re-examining the safety information available for active ingredients included in sunscreens marketed today. These ingredients have been used for many years. If, following its review of the available relevant safety data, US FDA determines that any of the active ingredients in the sunscreen products do not meet required safety standards; the agency will notify the public and work to remove that ingredient from the market promptly.

The new regulations will become effective for most manufacturers in one year. Manufacturers with annual sales less than US$25,000 have two years to comply.

Additional information about sunscreens, including the four documents discussed above, is now available on the US FDA Web site at www.fda.gov/sunscreens.

If you have any questions or concerns about this matter, please contact me at + 1 301-796-4600 or at Murray.Lumpkin@fda.hhs.gov.

Sincerely,

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Murray M. Lumpkin, M.D., M.Sc.
Deputy Commissioner
International Programs

International Outreach to Foreign Embassies