The Sunscreen Rule Update

Now that summer is upon us, here is a summary of the sunscreen rule. Have you seen claims on sunscreen labeling such as “waterproof” or “sweatproof”, or identify their products as “sunblocks”? Well, those terms cannot be used anymore. However, the compliance date for those companies with annual sales of less than $25,000 was delayed until December 17, 2013. Here are key aspects of this rule.

Standard Test

Establishes a standard test for over-the-counter sunscreen products that will determine which products are allowed to be labeled as “Broad Spectrum. Products that pass this test will provide protection against both ultraviolet B radiation (UVB) and ultraviolet A radiation (UVA).

Front Labeling: Under the new regulations, sunscreen products that protect against all types of sun-induced skin damage are labeled “Broad Spectrum” and “SPF 15” (or higher) on the front. Back Labeling: Informs consumers on the back of the product that sunscreens labeled as both “Broad Spectrum” and “SPF 15” (or higher) not only protect against sunburn, but, if used as directed with other sun protection measures, can reduce the risk of skin cancer and early skin aging. For these broad spectrum products, higher SPF (Sun Protection Factor) values also indicate higher levels of overall protection. By contrast, any sunscreen not labeled as “Broad Spectrum” or that has an SPF value between 2 and 14, has only been shown to help prevent sunburn.

Warning Statement: Sunscreen products that are not broad spectrum or that are broad spectrum with SPF values from 2 to14 must be labeled with a warning that reads: “Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.”

Claims

Water resistance claims on the product’s front label must tell how much time a user can expect to get the declared SPF level of protection while swimming or sweating, based on standard testing. Two times are permitted on labels: 40 minutes or 80 minutes. Manufacturers cannot make claims that sunscreens are “waterproof” or “sweatproof, or identify their products as “sunblocks.”   In addition, sunscreens cannot claim protection immediately on application (for example, “instant protection”) or protection for more than two hours without reapplication, unless they submit data and get FDA approval.http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm258416.htm

Delay Does not Protect the Ultimate User

Although the Sunscreen Rule was issued June 9, 2011with a compliance date of June 18, 2012, it was delayed until December 17, 2012. Further, the compliance date for those companies with annual sales of less than $25,000 was delayed until December 17, 2013.

What else is on the “Sunscreen Horizon”?

Sun Sprays 

An Advanced Notice of Rule Making was issued at the same time as the “Sunscreen Rule”. The Notice concerns a data request for safety and effectiveness information for sunscreen products formulated in certain dosage forms (e.g., sprays).

50+ Is there any Benefit to the 50+ Sunscreens?

FDA proposed a regulation that would limit the maximum SPF value on sunscreen labeling to “SPF 50+”. The FDA proposed Rule sets forth that the maximum labeled SPF value for over the counter (OTC) sunscreen products would be “50&plus”. The proposed rule comes after a data review showed that there is not currently sufficient data to indicate that there is additional clinical benefit above SPF 50. There was not adequate data that demonstrated that a sunscreen product with an SPF value over 50 provided an increase in clinical benefit over a sunscreen product with an SPF value of over 50.

Conclusion

As with other FDA regulation, time will tell if 50+ will be permitted as well as the effectiveness of sprays. Based on prior regulatory efforts that time could continue for years without a settled regulation.

Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use 21 CFR Parts 201 and 310