New Sunscreen Regulations from the FDA

By Dr. Sarah Khan, resident pharmacist for

The Food and Drug Administration (FDA) recently announced its proposal for new regulations affecting the way information on sunscreens is presented to consumers, citing that current standards for sunscreen package labeling haven’t been updated since 1978 and may be misleading or confusing.

FDA has evaluated the data and developed testing and labeling requirements for sunscreen products, so that manufacturers can modernize their product information and consumers can be well-informed on which products offer the greatest benefit, said Janet Woodcock, MD, director of the FDAs Center for Drug Evaluation and Research. These changes to sunscreen labels are an important part of helping consumers have the information they need so they can choose the right sun protection for themselves and their families.”

First, it’s best to understand the different types of radiation from the sun: UVA and UVB. UVA is the type of radiation associated with gaining a bronze glow, and can be found in tanning beds. Sunburns are caused by UVB radiation and are what the SPF in your sunscreen protects against. (SPF is the sun protection factor.) Currently these numbers range from 2 to about 70+. Both UVA and UVB radiation are linked to skin cancer. Most sunscreens currently available do have protection against UVA and UVB.

The new regulations promote a change in terminology:

  • Sunscreens that have UVA and UVB protection will be known as broad spectrum. SPF, which protects from UVB radiation, will remain on the package.
  • SPF ratings 15 and above will be permitted to state that they protect against early skin aging and reduce the risk of skin cancer. SPF’s below 15 help prevent sunburn but offer no other protection.
  • The highest SPF rating will be 50+ as studies have shown there is no additional benefit gained beyond this.
  • Waterproof or sweat proof sunscreens will be vigorously tested to determine the exact amount of time they provide sun protection. This helps consumers know how often it’s necessary to reapply in order to reduce the risk of burning. Most sunscreens should be reapplied every two hours, which is the longest amount of time allowed.

The new regulations take effect June 18, 2012, but the FDA hopes these new regulations will be put in to practice sooner. Smaller companies have two years to comply with the guidelines.

There are ways to reduce your risk of sun exposure, like staying in the shade, covering your skin with more clothing, and wearing sunglasses with UV protection.

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Kenneth D.
Kenneth Davies3 years ago


KrassiAWAY B.
Krasimira B.4 years ago

Noted with thanks.

Eternal Gardener
Eternal Gardener4 years ago

Again, can't keep up.

K s Goh
KS Goh4 years ago

Thanks for the article.

Andrew H.
- -.4 years ago

heres some info on sun and skin and possibly how much sun to get that may help:

Andrew H.
- -.4 years ago

if interested, heres Dr Mercolas take on sunscreen (yes his product is their, but it shows detail about what to be aware of):

Rita B.
Rita B.4 years ago

thanks for sharing! i use 50+ sunscreen everyday on my face, regardless the weather conditions! thanks!

Jonathan B.
Jonathan B.4 years ago

People do need to get a certain amount of sun to get Vitamin D, but this does not require sun tan beds or tanning outside, since excessive sun exposure can occur within an hour, due to the wrong kind of UV exposure.

Generally, any active adult doing errands and chores during the day is going to get enough sun to make their Vitamin D quota for the day.

The important thing to remember is that tans are just a corporate promoted fad that makes men and women feel less attractive, if they are pale.

Follow the money. Corporations make huge money on cosmetics, sunscreen, suntanning wear and bikini gear, and other sun related corporate product.

If you want to have young looking skin, wear a hat when doing lawnwork, (full brim, and not the baseball caps that let your ears cook). Yardwork also should be done with long sleeve white shirts, covered legs, and gloves.

If yardwork is done in the early morning, or after the sun is enough down in the sky to give the yard shadow, the gardener's skin is not going to suffer.

Sports and swimming entail a certain amount of unavoidable sun exposure, but staying aware of the impact of midday sun, and excessive activitys without head covering can help save not just the youth of your skin, but the health of your hair, which can be damaged by excessive UV on your scalp.

Elisabeth T.
Elisabeth T.4 years ago

Thanks for the info....

Shannon B.
Shannon M.4 years ago

For thousands of years our ancestors thrived in outdoor lifestyles without sunscreen. I won't use the stuff either (in fact I don't use any factory made health or beauty products, I make them all myself with truly natural ingrediants).

That's not to say I throw caution to the wind but I wear hats, make sure my shoulders are covered and stick to the shade as often as needed. I have never had a sunburn using these simple techniques.