FDA Sets New Standards for Sunscreens

As research and scientific understanding of how sun exposure and skin cancer have advanced, new information is available to help consumers protect themselves.

On June 18, 2012, The Food and Drug Administration (FDA) set new standards and regulations for sunscreen products. The new regulations won’t permit manufacturers to label their products as “sunblocks” or to claim “instant protection.” Water and sweat resistance claims will be limited. Tests will determine which sunscreen products will be allowed to be labeled “Broad Spectrum.” SPF factors will be more precise, based on new testing.

Understanding their provisions can help you protect yourself and your family this summer. Not all sunscreens are created equal. Their ingredients vary enormously. The new FDA standards will impact sunscreen labels in the following ways:

• The label “Broad Spectrum” will only apply to products that contain both UVA and UVB protection. Ultraviolet A (UVA) and B (UVB) radiation. Sunburn is primarily caused by UVB, but UVB protection alone is not sufficient. Both UVB and UVA cause sunburn, skin cancer and premature skin aging.
• Water and sweat resistance claims will have time limits. Labels will inform how much time the protection will last while swimming or sweating in the sun. Only two time periods will be allowed on labels: 40 minutes and 80 minutes. There is no such thing as “all day” sun protection.
• SPF factors will be based on how well different formulations of products work, like sprays and lotions. SPF factors will require recent data from testing. SPF values of less than 15 offer poor protection. Thus only Broad Spectrum products with SPF factors of 15 and higher will be labeled as able to “reduce the risk of sun damage, skin cancer and early skin aging.” There is no data to support sun protection factors higher than 50, so new labeling will allow a maximum SPF factor of “50+”.

Sun Safety Tips Beyond Sunscreen

No sunscreen will protect you completely from the possibility of immediate and long-term damage to your skin. Any type of skin is vulnerable to sun damage and skin cancer. Sun protection is a way of life. Follow these tips to help protect your skin:

• Limit your time in the sun, particularly between the hours of 10am to 4pm when the sun’s rays are the most intense.
• Seek shade whenever possible.
• Wear broad-brimmed hats, sunglasses and cover your skin with clothing.
• Use a broad spectrum sunscreen with an SPF factor of 15 or higher. Reapply sunscreen at least every two hours, more often if you are perspiring or spending time in the water.

Talk to your pharmacist about sunscreens. But also be an informed consumer: read sunscreen product labels carefully. Check out FDA websites about sun protection and sunscreen products. Be vigilant about the possibility of sun damage and talk to your doctor at the first sign of any skin abnormality.

Summer Skin Safety Brought to You by Sokolove Law 

With an estimated 41 percent of Americans being diagnosed with cancer during their lifetime, prevention and early diagnosis are key. There are certain cancers that are detectable in early stages by routine screening. If there is an opportunity to diagnose cancer and this opportunity is missed by a doctor, this “failure to diagnose” of your cancer may be considered medical malpractice. The staff at Sokolove Law is available to help. For legal help, call (800) 581-6358.

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