FDA is proposing to update the requirements for sunscreens to make sure they’re safe and effective for regular, lifelong use and provide the protections that consumers expect. In the meantime, consumers should continue to use broad spectrum sunscreens with SPF values of at least 15 and other protective measures as directed.
Sun safety is always in season, and it’s important to protect your skin from sun damage throughout the year, no matter the weather. Why? Exposure to the sun can cause sunburn, skin aging (such as skin spots, wrinkles, or “leathery skin”), eye damage, and skin cancer, the most common of all cancers.
And skin cancer is on the rise in the United States. The Centers for Disease Control and Prevention estimates there were more than 80,422 people diagnosed with melanoma of the skin—the most serious form of skin cancer—in 2015 alone. About 4.3 million people are treated for basal cell cancer and squamous cell skin cancer in the United States every year, according to a 2014 report from the Office of the Surgeon General.
The U.S. Food and Drug Administration (FDA) is continuing to evaluate sunscreen products to ensure that sunscreen active ingredients are safe and effective and that (among other things) available sunscreens help protect consumers from sunburn and, for broad spectrum products with SPF values of at least 15, from skin cancer and early skin aging caused by the sun when used as directed with other sun protection measures.
Reduce Your Risk for Sunburn, Skin Cancer, and Early Skin Aging Caused by the Sun
Sun damage to the body is caused by invisible ultraviolet (UV) radiation. Sunburn is a type of skin damage caused by the sun. Tanning is also a sign of the skin reacting to potentially damaging UV radiation by producing additional pigmentation that provides it with some—but often not enough—protection against sunburn.
Spending time in the sun increases your risk of skin cancer and early skin aging. People of all skin colors are at risk for this damage. You can reduce your risk by:
- Limiting your time in the sun, especially between 10 a.m. and 2 p.m., when the sun’s rays are most intense.
- Wearing clothing to cover skin exposed to the sun—such as long-sleeve shirts, pants, sunglasses, and broad-brim hats. Sun-protective clothing is now available. (The FDA regulates these products only if they are intended to be used for medical purposes.)
- Using broad spectrum sunscreens with a Sun Protection Factor (SPF) value of 15 or higher regularly and as directed. (Broad spectrum sunscreens offer protection against both UVA and UVB rays, two types of the sun’s ultraviolet radiation.)
- Always read the label to ensure you use your sunscreen correctly, and ask a health care professional before applying sunscreen to infants younger than 6 months.
In general, the FDA recommends that you use broad spectrum sunscreen with an SPF of 15 or higher, even on cloudy days.
- Apply sunscreen liberally to all uncovered skin, especially your nose, ears, neck, hands, feet, and lips (but avoid putting it inside your mouth and eyes).
- Reapply at least every two hours. Apply more often if you’re swimming or sweating. (Read the label for your specific sunscreen. An average-size adult or child needs at least one ounce of sunscreen, about the amount it takes to fill a shot glass, to evenly cover the body.)
- If you don’t have much hair, apply sunscreen to the top of your head, or wear a hat.
- No sunscreen completely blocks UV radiation, and other protections are needed, such as protective clothing, sunglasses, and staying in the shade.
- No sunscreen is waterproof.
- Certain sunscreens have FDA-approved New Drug Applications. Others are marketed under the FDA’s Over-the-Counter (OTC) Drug Review. Sunscreens are available in forms such as lotions, creams, sticks, gels, oils, butters, pastes, and sprays.
- Sunscreen products in forms including wipes, towelettes, body washes, and shampoos that are marketed without an FDA-approved application remain subject to regulatory action.
It’s Important to Read Sunscreen Labels
Although UVB rays are the primary cause of sunburn, both UVA and UVB rays contribute to skin cancer. All sunscreens protect against the sun’s UVB rays, but only those that are broad spectrum also have been shown to also provide sufficient protection against UVA rays to reduce the risk of skin cancer and early skin aging caused by the sun when used as directed with other sun protection measures.
Current FDA regulations that apply to sunscreens marketed without approved applications and containing certain active ingredients state:
- Products that pass FDA’s broad spectrum requirements can be labeled “broad spectrum.”
- Sunscreens that are not broad spectrum or that lack an SPF of at least 15 must carry a 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.”
- Water resistance claims, for 40 or 80 minutes, tell how much time you can expect to get the labeled SPF-level of protection while swimming or sweating.
- Manufacturers may not make claims that their sunscreens are “waterproof” or “sweat proof.”
- Products may not be identified as “sunblocks” or claim instant protection or protection for more than two hours without reapplying.
For more information about sunscreen and to watch videos about sunscreen, visit the FDA’s sunscreen website.
Risk Factors for Harmful Effects of UV Radiation
Remember, people of all skin colors are potentially at risk for sunburn and other harmful effects of UV radiation, so always protect yourself. Be especially careful if you have:
- pale skin
- blond, red, or light brown hair
- been treated for skin cancer
- a family member who has had skin cancer
If you take medications, ask your health care professional about sun-care precautions. Some medications may increase sun sensitivity. Even on an overcast day, up to 80 percent of the sun’s UV rays can get through the clouds. Stay in the shade as much as possible.
The FDA is committed to ensuring that safe and effective sunscreen products are available for consumer use. Because the body of scientific evidence linking UVA exposure to skin cancers and other harms has grown significantly in recent years, FDA is proposing a new requirement that all sunscreen products with SPF values of 15 and above must be broad spectrum, and that as the SPF of these products increases, broad spectrum protection increases as well. FDA is also proposing changes to the labeling of SPF values to make it easier for consumers to compare and choose sunscreen. FDA is also proposing raising the maximum proposed SPF value from SPF 50+ to SPF 60+.
Protect Your Eyes With Sunglasses
Sunlight reflecting off sand, water, or even snow, further increases exposure to UV radiation and increases your risk of developing eye problems. Certain sunglasses can help protect your eyes. When using sunglasses:
- Choose sunglasses labeled with a UVA/UVB rating of 100% to get the most UV protection.
- Do not mistake dark-tinted sunglasses as having more UV protection. The darkness of the lens does not indicate its ability to shield your eyes from UV rays. Many sunglasses with light-colored tints, such as green, amber, red, and gray can offer the same UV protection as very dark lenses.
- Children should wear sunglasses that indicate the UV protection level. Toy sunglasses may not have UV protection, so be sure to look for the UV protection label.
- Consider large, wraparound-style frames, which may provide more efficient UV protection because they cover the entire eye-socket.
This is especially important when doing activities around or on water because much of the UV comes from light reflected off the water’s surface.
- Understand that pricier sunglasses don’t ensure greater UV protection.
- Even if you wear contact lenses, wear sunglasses that offer UV protection.
- Know that sunglasses are the most effective when worn with a wide-brim hat and sunscreen.
See more information on sunscreen safety here.