FDA Revises, Strengthens Sunscreen Regulations

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In an effort to ensure that consumers have the information they need to make wise sun protection choices, the Food and Drug Administration (FDA) recently announced an updated list of sunscreen regulations [1].

Briefly summarized, the new regulations are:

• Sunscreens that provide significant protection against both types of UV light that reach Earth’s surface in significant quantities (UVA and UVB) may be labeled “broad spectrum.”
• Broad spectrum sunscreens with sun protection factor (SPF) 15 or higher may claim to help reduce the risk of skin aging and skin cancer when used appropriately and in conjunction with other sun protection measures, such as protective clothing.
• Sunblocks that are not broad spectrum and have SPF below 15 must carry the warning: “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.”
• The terms “waterproof,” “sweat-proof,” and “sunblock” may no longer be used, on the grounds that no sunscreen is truly waterproof or sweat-proof, and the term “sunblock” overstates the effectiveness of sunscreen.
• Sunscreens can not claim to provide instantaneous protection or protection lasting more than 2 hours without submitting supporting evidence to the FDA.
• Sunscreens claiming to be water-resistant must indicate whether data indicate that the sunscreen remains effective for 40 or 80 minutes of water exposure or sweating. Those sunscreens that do not claim water resistance must direct consumers to use a water-resistant sunscreen for water sports or during periods of sweating.
• All sunscreen bottles must provide a “Drug Facts” label (as is standard on over-the-counter pharmaceuticals).

There is also a proposed rule that sunscreens with SPF greater than 50 will be required to use the designation “SPF 50+” rather than stating a specific value. This is because insufficient data supports the effectiveness of SPF greater than 50.

Sunscreens are an important component of safe sun behavior because, while they can never provide complete protection against UV radiation, they either reflect (barrier sunscreens) or absorb (chemical sunscreens) some of the UV radiation that would otherwise penetrate the skin. There are two major subclasses of UV that reach Earth’s surface: UVA and UVB. Colloquially, UVA rays are sometimes called “tanning rays,” in contrast to “burning rays” (UVB). However, this common parlance, often used by indoor tanning salons to suggest that their beds are safer than outdoor sun exposure, is dangerously misleading. Both UVA and UVB rays penetrate the skin and cause damage. Sufficient UVB exposure causes a local inflammation reaction — reddening or a sunburn — in addition to damaging skin cell DNA and increasing the risk of skin cancer. UVA does not cause a local inflammation reaction. Instead, it promotes tanning of the skin (production and release of melanin, which is a brown chemical). Tanning, though sometimes viewed as healthy or protective, is actually an indication that significant skin damage has occurred. In addition to causing the tanning response, UVA also impacts deep skin structures, causing protein breakdown. This leads to the formation of wrinkles and skin sagging, and also increases the risk of skin cancer.

One of the major concerns the FDA is still working on addressing is that SPF ratings apply only to UVB protection. Because UVA exposure doesn’t result in reddening and burning of the skin, it’s quite difficult to determine how much UVA an individual has been exposed to. This makes the development and testing of a UVA protection scale logistically difficult. Despite the lack of a UVA protection rating system, broad spectrum sunscreens are considered the most effective against UVA radiation, and are the wisest choice for outdoor activities.

Regardless of which sunscreen is used, the U.S. Centers for Disease Control and Prevention (CDC) emphasizes that sunscreen is only one part of safe sun behavior [2]. Hats, sunglasses, protective clothing, appropriate use of shade, and staying out of the sun during the most intense hours of sunlight are also important skin cancer prevention measures.

References

1. FDA Sheds Light on Sunscreens. Consumer Update, U.S. Food and Drug Administration. 2012 May 17.
2. Skin Cancer Prevention. Centers for Disease Control and Prevention. 2011 Nov 30.