FDA Reveals New Regulations on Sunscreens

The U.S. Food and Drug Administration will be requiring manufacturers to make changes on sunscreen labels in order to facilitate consumer understanding of the safety and effectiveness of different sun defense products. 

New guidelines announced on Tuesday will establish more stringent standards for over-the-counter sunscreens, particularly regarding the designation “Broad Spectrum” on labels. 

By summer 2012, all products labeled “Broad Spectrum” must be proven to protect against both UVA and UVB rays, as determined by newly established testing procedures that will measure UVA radiation protection in relation to the amount of UVB protection provided. 

Traditionally, sunscreen manufacturers have marketed a level of “sun protection factor” (SPF) to indicate the corresponding level of protection afforded to the skin specifically against UVB rays, which are the primary cause of sunburn. 

Both UVA and UVB rays, however, can cause skin cancer and premature aging of the skin.  So, misleading sunscreen labels boasting “protection from the sun’s rays” and “protection for skin against damage from the sun” may, in fact, lack adequate protection from the full range of the sun’s light. 

Per the FDA’s web site, the regulations are part of “the agency’s ongoing efforts to ensure that sunscreens meet modern-day standards for safety and effectiveness and help consumers have the information they need so they can choose the right sun protection for themselves and their families.”

Non-broad spectrum sunscreens and broad spectrum sunscreens with an SPF of 2 to 14 will only be permitted to advertise help preventing sunburn, and these products may not advertise any risk reduction of skin cancer or early skin aging with use. 

Only broad spectrum sunscreens with an SPF of 15 or higher may claim to protect against the triple threat of sunburn, skin cancer, and premature skin aging. 

Additionally, manufacturers may no longer market sunscreens as “sunblock” or claim that they are “waterproof” or “sweatproof,” as these terms overstate the effectiveness of the products. 

“There is no such thing as a waterproof or sweatproof sunscreen.  Once wet, all sunscreens begin to lose effectiveness,” explains an FDA video on the new regulations. 

Instead, products may be designated “water resistant” if applicable, but they must also indicate the length of time water resistance lasts – either 40 or 80 minutes – on the front label.  In the absence of the term, the sunscreen product should not be considered water resistant. 

“Sunblock” will be disallowed because no sunscreen can completely protect against the sun’s ultraviolet rays.  For the most complete protection from the sun’s rays, the FDA is encouraging a multi-faceted approach.

Using broad spectrum sunscreens with an SPF of at least 15 as directed, in conjunction with other safety measures such as wearing protective clothing, avoiding the sun during the peak hours of 10 AM to 2 PM, and periodically seeking shade, are the safest ways to avoid harm from the sun. 

While higher SPF levels offer more protection against sunburn-inducing UVB rays, the FDA announced that there is no evidence that SPF levels above 50 provide any additional benefits. 

A proposed FDA rule seeks to set the maximum allowable advertised level of SPF at 50.  The agency is allowing time for public comment on the regulation before finalizing it. 

Also still awaiting data and public comment are new regulations being considered regarding dosages of sunscreen products.  Because there are significant discrepancies in the manner of application of spray sunscreens versus conventional lotions, oils, and creams, a standard “safe and effective” dosage has yet to be determined. 

In the meantime, the FDA publicly assured that it will continue to monitor current and future sunscreen formulas to ensure that the products offered to consumers are safe.

Photo credit: fda.gov/ForConsumers/ConsumerUpdates/ucm049091.htm

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