FDA Tightens Sunscreen Safety Standards After Blood Absorption Study: What's Changing

The FDA is overhauling sunscreen regulations after discovering that common UV-blocking chemicals can be detected in the bloodstream following sunscreen application, prompting new safety standards and labeling requirements. In May 2019, FDA researchers published findings in the medical journal JAMA showing that four photoprotective chemicals, including oxybenzone and avobenzone, absorb into the body after sunscreen use. While there is currently no evidence these chemicals cause harm once inside the body, the discovery prompted regulators to require manufacturers to submit additional safety data and implement significant changes to how sunscreens are formulated and labeled.

What Did the FDA Study Find About Sunscreen Absorption?

A small clinical trial conducted by FDA researchers revealed that UV-blocking chemicals can enter the bloodstream after sunscreen is applied to skin. The study detected four key ingredients: oxybenzone, avobenzone, ecamsule, and octocrylene. The timing of this discovery matters because sunscreen use has evolved dramatically. What was once a beach-bag item applied occasionally is now a daily necessity for many people, applied repeatedly throughout the day to face, neck, and exposed skin. This increased frequency and duration of use raised questions about long-term exposure to these chemicals that were approved decades ago, before anyone suspected they could be absorbed systemically.

"It's important to remember that at this time, there is no evidence sunscreens currently on the shelves have negative long-term impacts on human health. However, they can protect you from cancer and aging caused by radiation from the sun. People sometimes forget the sun is a star, fueled by nuclear fusion, that causes radiation burns and cancer to human skin," said Dr. Kevin McMullen.

Dr. Kevin McMullen, Dermatologist

Which Sunscreen Ingredients Work Differently?

The FDA's proposed changes focus on two categories of sunscreen ingredients with very different mechanisms. Chemical sunscreens work by absorbing into the skin and then absorbing UV rays before they can damage skin cells. Mineral sunscreens, by contrast, use physical blockers like zinc oxide and titanium dioxide that sit on top of the skin and bounce off UV rays. The FDA has already cleared two mineral ingredients as safe and effective: zinc oxide and titanium dioxide. These physical blockers do not absorb into the bloodstream in the same way chemical sunscreens do, making them the focus of regulatory approval.

What Are the Specific New FDA Sunscreen Standards?

The FDA's proposed updates represent the most significant overhaul of sunscreen regulations in years. These changes were expected to be finalized in November 2019, with manufacturers given one year to comply with the new standards. Here's what changed:

  • SPF Label Maximum: The maximum sun-protection factor on sunscreen labels increased from SPF 50+ to SPF 60+, allowing manufacturers to market higher protection levels.
  • Broad-Spectrum Requirement: All sunscreens with SPF values of 15 and higher must now offer broad-spectrum protection against both ultraviolet A (UVA) and ultraviolet B (UVB) radiation.
  • Front-Label Ingredient Listing: Manufacturers must include a list of active ingredients on the front of sunscreen packaging, making it easier for consumers to identify which UV-blocking chemicals are in their product.
  • Combo Product Restrictions: The FDA suggests that sunscreen-insect repellent combination products are not safe and effective, discouraging manufacturers from marketing these dual-purpose products.

Why Is UVA Protection Getting More Attention?

The new FDA standards place particular emphasis on UVA protection, reflecting emerging research about how this type of radiation damages skin. UVA accounts for approximately 90 percent of UV radiation reaching Earth, penetrates clouds and glass year-round, and causes free radical generation that contributes to skin aging. Mounting evidence suggests that UVA may damage DNA more significantly than previously thought, which is driving the regulatory push to ensure consumers have full UVA and UVB protection.

How to Select a Sunscreen That Meets Updated Standards

As the new FDA standards have been finalized, consumers can now look for sunscreens that comply with the updated requirements. Here are key features to prioritize when selecting a sunscreen:

  • Mineral-Based Formula: Look for sunscreens listing zinc oxide or titanium dioxide as the primary active ingredient, as these are FDA-approved mineral blockers that do not absorb into the bloodstream in the same way chemical sunscreens do.
  • Broad-Spectrum Label: Ensure the product explicitly states it provides broad-spectrum protection against both UVA and UVB radiation, not just one type of ultraviolet exposure.
  • Reef-Safe Certification: Check for products that are free from oxybenzone and other chemicals known to harm coral reefs, especially if you plan to swim in ocean water regularly.
  • Ingredient Transparency: Review the active ingredients listed on the front of the packaging to understand exactly which UV-blocking chemicals are in the product you're considering.
  • Water Resistance Duration: Look for products labeled as water-resistant for either 40 or 80 minutes, depending on your activity level and how often you plan to reapply sunscreen.

What About Environmental Concerns With Chemical Sunscreens?

Beyond human health, one chemical sunscreen ingredient has faced intense scrutiny for environmental damage: oxybenzone. This ingredient has been linked to harming coral reefs, prompting Hawaii to ban sunscreens containing oxybenzone altogether. The chemical's effects on marine ecosystems have made reef-safe sunscreen formulations increasingly important to consumers and regulators alike. Mineral sunscreens, which rely on zinc oxide and titanium dioxide, are generally considered reef-safe because these physical blockers do not dissolve into water or accumulate in marine organisms the way chemical absorbers can.

What Should Consumers Do Right Now?

Experts emphasize that the discovery of chemical sunscreen absorption should not discourage people from using sunscreen at all. The risks of unprotected sun exposure, including skin cancer and premature aging, far outweigh any theoretical concerns about chemical absorption. Dr. McMullen recommends a comprehensive sun protection strategy that includes multiple approaches: wearing sun-protective clothing, avoiding direct sun exposure between 10 a.m. and 2 p.m., applying broad-spectrum sunscreen daily, and reapplying every 90 to 120 minutes while outdoors. The regulatory shift reflects a broader commitment to ensuring that the products we use to protect ourselves from the sun are as safe as possible, both for our bodies and for the environment.