Sunscreen Safety: Understanding the FDA's Requirements


megan-summers-author-banner 101613This blog post originally published on August 30, 2011.

The FDA has requirements for over-the-counter sunscreens. Prior to the changes, the regulations on sunscreen only addressed concerns with protection against Ultraviolet B (UVB) rays. Current standards include regulations for Ultraviolet A (UVA) rays.

Understanding what you may see on sunscreen labels will allow you to choose the right sun protection for you and your family.

Let's start with a brief discussion about sunlight.

What is sunlight?

Sunlight consists of two types of harmful ultraviolet radiation: UVA rays and UVB rays.

UVA rays penetrate into the dermis, the thickest layer of skin and have long-term effects on the skin. They are known to lead to signs of premature aging such as wrinkles and age spots. UVB rays produce short term effects on the skin and are the primary cause of sunburn.

An easy way to remember is UVA rays are "aging" rays and UVB rays are "burning" rays. Both can cause skin cancer.

Why is it so important to protect my skin against sunlight?

Two children in swimsuits at the edge of the ocean.Too much unprotected sun exposure can cause skin, eye damage or even cancer.

"One or more blistering sunburns in your childhood can more than double your chances of developing melanoma later in life," says Stuart Siegel, MD, director of the Children’s Center for Cancer and Blood Diseases at Children’s Hospital Los Angeles.

Luckily, with the right precautions and use of sunscreen, you can greatly reduce the chances of developing skin cancer.

This is why it's so important to always remember your sunscreen!

So, what do the FDA sunscreen rules mean for me?

Before you slather up with your sunscreen, be sure to read the label. The FDA's sunscreen regulations (summarized below) are intended to help you better understand the protection you're getting.

Broad-Spectrum Designation

Sunscreens may be labeled as "broad-spectrum" only if they provide protection against both ultraviolet A and ultraviolet B radiation.

Only broad-spectrum sunscreens with a Sun Protection Factor (SPF) of 15 or higher can state that they protect against skin cancer if used as directed with other sun protection measures. Sunscreens with an SPF of 2-14 will be required to have a warning stating that the product has not been shown to help prevent skin cancer or early skin aging.

Sunblock, Sweatproof and "Waterproof" Defined

Manufacturers are no longer allowed to use the words waterproof, sweat-proof or identify their products as sunblocks. Why? Because these descriptions overstate their effectiveness. Sunscreens cannot claim to provide sun protection for more than two hours without reapplication or to provide protection immediately following application (instant protection).

Waterproof versus Water-Resistant

A sunscreen may claim to be water-resistant, however, it must claim in minutes the amount of time for which the product is water resistant during swimming or sweating, based on test results.

Drug Facts

All sunscreens must include standard "Drug Facts” information on the back and/or side of the labeling.

Products That Contain Sunscreen

Cosmetics, moisturizers and any other products that claim to provide Broad Spectrum SPF protection are regulated as sunscreen drug products. That means the FDA's sunscreen regulations apply to these products.

The most important way to protect you and your family is to read the label carefully! Look for a "broad-spectrum" sunscreen that will protect you from both UVA and UVB radiation with an SPF value of at least 15. Keep in mind that a sunscreen with an SPF of 30 to 45 SPF is recommended, in combination with other protective measures.

Don't be fooled by the term "waterproof" because all sunscreens eventually wash off. Note how long the sunscreen remains effective when swimming or sweating and reapply often.

The Eyes Have It

Also, don’t forget your children’s eyes when spending time in the sun.A smiling little girl sports a pair of purple sunglasses.

"Look for kids' sunglasses that block 99 to 100 percent of both UVA and UVB rays when shopping for kids’ sunglasses," says Thomas Lee, MD, a pediatric eye surgeon at The Vision Center at Children’s Hospital Los Angeles. "Exposure to bright sunlight can result in eye irritation and the development of cataracts later in life."

Updated on Friday, May 2, 2014 at 2:35 p.m.