New FDA Rules for Sunscreens

When buying sunscreen, it is often hard to understand what kind of protection each product offers. Sunscreen isn’t cheap; we want the bang for our buck. The FDA has finally made some reforms to the rules for the labeling of sunscreen:

• Water and sweat resistance – Products may no longer claim to be waterproof or sweat-proof; that is a misleading overstatement. Sunscreen labels may claim to be water resistant, but must indicate the amount of time the product remains effective, either 40 or 80 minutes. Sunscreens that are not water resistant must include directions to use a water resistant sunscreen if swimming or sweating.
• Timing – Some sunscreens claim “instant protection.” The new rules force companies to seek FDA approval on submitted data in order to make such a claim. The same goes for sunscreens that claim to provide protection for more than 2 hours without reapplication.
• Broad Spectrum designation - In order to be labeled as “Broad Spectrum SPF [value]” on the front label, the sunscreen must pass the FDA’s broad spectrum test procedure, which measures a product’s ultraviolet A (UVA) protection relative to its ultraviolet B (UVB) protection.
• Use claims – If, and only if, a sunscreen has the broad spectrum designation and has an SPF of 15 or higher, may the label make the claim to reduce the risk of skin cancer and early skin aging if used as directed with other sun protection measures. If it does not meet both of these requirements, the sunscreen simply helps prevent sunburns.
• Drug Facts – All sunscreens must include standard Drug Facts information on the back and/or side of the container.

These amendments do not take effect until 2012. If your favorite brand comes out with a new design next year, you will know why! There is also a proposed rule that the highest SPF label would be 50+, because there is not sufficient data to show that products with SPF values higher than 50 provide greater protection for users than products with SPF values of 50.

By the way, do you know the difference between sunblock, sunscreen, and sun tan lotion? Once upon a time, these terms had distinct definitions. Sunblock was a thick lotion that completely blocked the sun’s rays, while sunscreen, which is the only one of the three that should have an indicated SPF value, simply reduced the ray’s harmfulness. Sun tan lotion referred to what is now more commonly known as “tanning lotion,” a product meant to absorb UV rays, not weaken or reflect them. Somehow, the lines between these products have become blurred. The new FDA rules now ban the labeling of a product as a “sunblock,” which is another misleading overstatement.