Einstein/Montefiore Department of Medicine

FDA Sunscreen Guidelines

Adam Friedman, MD 

What the New Guidelines Mean 

Adam Friedman, MD
The Food and Drug Administration (FDA) recently announced several significant changes to sunscreen product regulations to ultimately help people pick sunscreens with a greater degree of confidence. First, and most importantly, the FDA's newly established guidelines evaluate the effectiveness of not only ultraviolet B radiation (UVB) ingredients, but also ultraviolet A (UVA). UVB is the form that causes sunburns (think B for burn), UVA can cause sun-related skin aging. Both UVA and UVB cause skin cancer. SPF numbers, which indicate the effectiveness of a product in blocking UVB, have historically been FDA regulated. However, up until now, the various UVA-protecting ingredients were not FDA regulated and therefore their effectiveness was not tested through a standardized evaluation. With the new guidelines in place, the public will know if a sunscreen is truly "broad spectrum" (covering both UVA and UVB).

The new regulations specify and restrict the claims that sunscreen manufacturers can make. Unless the FDA deems a product SPF 15 or higher and is broad spectrum, the manufacturer cannot state that the product protects against age spots, wrinkles, or skin cancer. Products with SPF 2-14, or those with higher SPF numbers but no broad spectrum, can only claim to prevent sunburn. 

See Dr. Friedman's "Good Morning America" interview on sunscreen regulations.
The terms "waterproof" and "sweatproof" terms may no longer be used. A product may clam to be "water resistant" only after it has been evaluated by the FDA to maintain its sunblock abilities after 40 minutes in water or 80 minutes of sweating.

Sun Safe Tips for Summer  

  1. When choosing a sunscreen, look for the following:

    • The American Academy of Dermatology recommends SPF of 30 or higher. I recommend using both a broad-spectrum sunscreen and a lip balm with SPF 30 or higher.
    • The sunscreen you choose must say "broad spectrum" or "UVA+UVB" on its label.
    • Choosing a water-resistant vs. a non-water-resistant sunscreen is helpful, but remember to reapply it after 40 minutes in the water or toweling off.
    • Most regulatory bodies and physician-led organizations recommend physical blockers (titanium dioxide and zinc oxide) over the physical or chemical absorbers (avobenzone, ecamsule) because they work better, are potentially safer, and are effective broad-spectrum blockers. However, it is advised to use combination products  with both blockers and absorbers, for the benefit of two different mechanisms of UV protection.

    As long as you follow the label recommendations indicated above, the product you purchase should do the trick.

  2. The biggest mistakes are made with sunscreen application. To avoid these mistakes:

    • Apply sunscreen at least 15-30 minutes before going outdoors.
    • Apply sunscreen whether it is sunny or cloudy, as UVA can get through clouds, shade, and even windows.
    • Apply sunscreen generously to your skin. Most people apply only 20-30 percent of what they should. Use about a shot-glass worth to cover all exposed areas. Don't forget to apply it to your ears, lips, neck, and hands.
    • Reapply sunscreen every two hours, after getting out of the water, or after perspiring heavily.
  3. Sunscreen alone is not enough to protect you from skin cancer. Seek shade during peak hours (10 am and 4 pm) and wear hats, sunglasses, and protective clothing whenever possible.
  4. Toss your old sunscreen products. Sunscreens have expiration dates, but if you even have to question it, dump it.
  5. Sun protection starts at day one! Children, especially babies, are extremely sensitive to UV radiation. Children under six months should not have sunscreen applied to their skin. For children older than six months, I recommend a product with a physical blocker such as titanium dioxide or zinc oxide.
  6. Be mindful about your medications and skin products, as they may make you more sensitive to the sun or generate damaging free radicals (chemical reactions) when exposed to sunlight. As a dermatologist, I commonly see two types of reactions: a photoallergic (true allergy) reaction brought on by this combination (this only occurs in certain people); and a phototoxic reaction, similar to a sunburn, which can occur in anyone.
  7. Make sure you are having your skin checked at least once a year. One in five Americans will get some form of skin cancer during his or her lifetime. Just one blistering sunburn doubles the risk of getting melanoma.

Other Factors to Consider 

  1. The major flaw with the new FDA guidelines is the decision to postpone doing away with SPF numbers higher than 50. SPF of 15 will block 93% of UVB, SPF 30 will block 97%, and SPF 50 aroung 98.5%. How much higher can you go? Super-high SPFs give a false sense of confidence. When out in the sun, whether you are wearing sunscreen with SPF of 50 or 1000, you still need to reapply it every two hours, or after being in the water, toweling off, or perspiring heavily.
  2. The FDA has also commented that it will evaluate sunscreen sprays and develop guidelines for their use. Althought sunscreen sprays are easier to apply, there are several potential problems with their use:

    • There is no system in place that compares the dosing of sunscreen creams or lotions to that of sprays, making it difficult to know how much is enough.
    • Environmental factors such as wind may play a role in limiting a sunscreen spray's effect. Though you may spray an entire can, the wind may take half of it away from your skin. 
    • There is some theoretical concern with regards to inhalation of the sunscreen spray, though there is no research to date that supports these claims.

Dr. Friedman is Director of Dermatologic Research and Clinical Instructor of Dermatology at Albert Einstein College of Medicine/Montefiore Medical Center. 

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