Shining a light on new FDA Sunscreen Rules

KONICA MINOLTA DIGITAL CAMERAYes, sunscreen is a must. You know it, we know it- but do you know exactly what’s in your sunscreen and how it works? Are you being tricked into buying products that do not work, make false claims, or are more expensive than they should be? Let’s help you figure it out!

Gone are the days when even savvy consumers believed that slapping on a sunscreen with an SPF of 2, 4 or 8 would protect them from scorching sunburns. Unless you have been hiding in a very dark, sunless cave, you know well enough now that any SPF lower than 15 is a joke. And sunburns are the least of your problems when you think of all the other sun related issues such as premature aging of the skin, wrinkles, moles, and skin cancer.

SPF By the Numbers

In recent years, sunscreens with SPF in the ranges of 70, 80 and 100+ have been popping up on shelves. While you may think the higher the SPF, the more protected you are, most of these claims are gimmicks. Many experts feel that these claims may lull consumers into a false sense of security and actually encourage them to stay out in the sun longer, creating more damage to their skin health. Studies show that any sunscreen above SPF 30 only provides a tiny fraction of additional protection. SPF 30 filters out a little under 97% of UVB rays. SPF 50 filters out 98% while SPF 100 blocks 99%.[1] No sunscreen, no matter what level of SPF, blocks 100% of UV rays. The FDA may eventually make SPF 50 the limit for sunscreen claims.


Sunscreen labels are already required by the FDA to carry a Sun Protection Factor (SPF) level that informs users how well the product protects against UVB light, which primarily causes sunburn. The FDA requires that sunscreen labeling be expanded to provide an indication of broad-spectrum protection that informs consumers whether the product shields them from both UVA and UVB light.[2] This enhanced labeling will now include in its focus UVA protection, as the UVA rays are more deeply penetrating to the skin than UVB.

Did you know that many sunscreens that claim to be broad-spectrum aren’t necessarily protecting you from both UVB and UVA rays? There have been no FDA-approved tests to prove it’s true. Now, any broad-spectrum sunscreen must first meet FDA standards to ensure its accuracy. To get the broad-spectrum claim, manufacturers have to show that the amount of UVA protection proportionally increases as the SPF level increases. The product also needs to be SPF 15 or higher.

By contrast, any sunscreen not labeled as “Broad Spectrum” or that has an SPF value between 2 and 14, has only been shown to help prevent sunburn. Sunscreen products that are not broad spectrum or that are broad spectrum with SPF values from 2 to14 will be labeled with a warning that reads: “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.”[3] Sunscreens that meet the requirements of the test and are labeled as SPF 15 or above will be clearly marked as a product that "reduces the risk of early skin aging and skin cancer."[4]

SPF and Water

In the past few years, there has been significant controversy over sunscreens claiming to be “waterproof” or “sweat proof.” Now, the FDA is cracking down on these terms on sunscreen labeling. Sunscreens can no longer claim to be “waterproof” and “sweat proof” because all of them wash off. They don’t protect skin from UV rays once they’re soaked in water for a certain amount of time. Instead, labels can only read “water resistant,” because they can protect skin while in the water, but only for a limited time. If a sunscreen claims to be water resistant, it must also include how long the sunscreen is effective when in water or when sweating. Water resistance claims on the product's front label must tell how much time a user can expect to get the declared SPF level of protection while swimming or sweating, based on standard testing. Two times frames will be permitted on labels: 40 minutes or 80 minutes. [5]

The Two-Hour Rule

Another big change is that sunscreens, unless they’ve gained approval from the FDA, cannot claim to protect your skin from UV rays for more than two hours, unless reapplied. The FDA is also including provisions in their new regulations to prohibit sunscreen manufacturers from claiming protection immediately on application (for example, “instant protection”) or protection for more than two hours without reapplication, unless they submit data and get approval from FDA.[6]

Be a Detective

Have you noticed any spots or moles that have altered recently? Visit your dermatologist. Even if you don’t see any skin changes, visit your dermatologist annually for a skin exam, just to be on the safe side. Even if you think you are 100% safe 100% of the time, always keep on the lookout for signs of skin cancer. Your chances of recovery are infinitely better with early detection. The Skin Cancer Foundation recommends a monthly self-check.

Future Changes

This is not the end of the sunscreen crackdown. The FDA is also determining whether spray sunscreens are effective or safe and will continually watch dog the sunscreen labeling and testing requirements. These measures are necessary, says Lydia Velazquez, PharmD, in FDA’s Division of Nonprescription Regulation Development, because “our scientific understanding has grown. We want consumers to understand that not all sunscreens are created equal.” This new information will help consumers know which products offer the best protection from the harmful rays of the sun.[7] We will be posting an article on dermatologist approved sunscreens very soon, so make sure to stay up-to-date!

Authors: Mitzi Runyan & May Jabado

Sources:  [1] (2009)

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