Is Sunscreen Getting Safer? Here’s What the FDA Wants to Happen in 2019

John Egan - The Upside Blog

by | Read time: 4 minutes

Safer, more effective sunscreens are on the horizon in the U.S.

In February 2019, the U.S. Food and Drug Administration (FDA), which regulates sunscreens, unveiled a proposal to institute sweeping revisions in federal sunscreen regulations — regulations that federal officials and consumer advocates say are long overdue for an overhaul.

Woman With Sun Hat Sitting on Beach Thinking About FDA Sunscreen Regulations While Smoothing Lotion on Her Leg |

Broad-spectrum sunscreens with SPF values of at least 15 are critical to the arsenal of tools for preventing skin cancer and protecting the skin from damage caused by the sun’s rays, yet some of the essential requirements for these preventive tools haven’t been updated in decades,” Dr. Scott Gottlieb, head of the FDA, says in a statement.

“Since the initial evaluation of these products, we know much more about the effects of the sun and about sunscreen’s absorption through the skin. Sunscreen usage has changed, with more people using these products more frequently and in larger amounts,” Gottlieb adds. “At the same time, sunscreen formulations have evolved as companies innovated.”

Here’s what you need to know about pending changes in nonprescription, over-the-counter sunscreens that you and your family use.

Among other things, the FDA proposal seeks to:

  • Raise the maximum SPF value on sunscreen labels from SPF 50+ to SPF 60+.
  • Revamp labeling requirements for sunscreens. The FDA says consumers would be better able to identify active ingredients, be clearly alerted about sunscreens that fail to meet standarfor preventing skin cancer and be more aware of on-the-label notices regarding SPF, broad-spectrum benefits and water resistance.
  • Require sunscreens with an SPF of at least 15 to offer broad-spectrum protection, which shields your skin from harmful UVA and UVB rays.
  • Tighten rules for sunscreen testing.
  • Keep sunscreens containing insect repellents from qualifying as “generally recognized as safe and effective,” or GRASE.
  • Include sprays, oils, lotions, creams, gels, butters, pastes, ointments and sticks in the group of sunscreen products that can be deemed GRASE.

Perhaps the most widespread modification proposed by the FDA would affect which of the 16 FDA-approved active ingredients in sunscreens could be characterized as GRASE. All sunscreens sold in the U.S. are supposed to list all active and inactive ingredients.

Under the FDA’s proposal, two active ingredients, zinc oxide and titanium dioxide, would be cleared as GRASE for sunscreen; both are found in mineral-based sunscreens. Meanwhile, while two other active ingredients — PABA and trolamine salicylate — would not earn the GRASE designation due to safety concerns. Neither PABA nor trolamine salicylate is available in sunscreens sold in the U.S.

The GRASE status of the remaining 12 ingredients, including potentially dangerous oxybenzone, would remain up in the air until the FDA receives sufficient data about their safety.         

The FDA is collecting public comments about the FDA proposal until May 29, 2019.

Based on early comments, health advocates are pleased about the FDA’s plan.

In a statement, the Skin Cancer Foundation says it “applauds the FDA for working to elevate standards for effective sun protection.”

The nonprofit Environmental Working Group (EWG) describes the FDA’s proposal as “a big step toward cleaning up a largely unregulated industry” and “a major win for public health.”

ast taking serious steps to finalize rules that would require sunscreen companies to make products that are both safe and effective,” David Andrews, a senior scientist at EWG, says in a statement.

EWG raises the most concern about the sunscreen ingredient oxybenzone, which it says has been detected in breast milk and can potentially disrupt the body’s endocrine system. The endocrine system creates and releases hormones.

In its response to the FDA’s plan, the American Academy of Dermatology Association notes that skin cancer is the most common form of cancer in the U.S. The association adds that the proposal does not conclude that over-the-counter sunscreens available now are unsafe.

“As the proposed [FDA] rule is finalized, we encourage the public to continue protecting themselves from the sun’s harmful ultraviolet rays,” the association’s president, Dr. Suzanne Olbricht, says in a statement. “If you are concerned about the safety of the ingredients in your sunscreen, talk to a board-certified dermatologist to develop a sun protection plan that works for you.”

Dr. Len Lichtenfeld, acting chief medical officer of the American Cancer Society, recommends buying and using sunscreens that are sold and marketed in the U.S. because of limited information about the safety and effectiveness of sunscreens made in other countries.

“Each person should make an individual decision that’s most appropriate for themselves,” Lichtenfeld says on the Cancer Society’s website. “But the experts who have looked at the data have concluded that the potential risk of not using sunscreen far outweighs the risks of using sunscreen.”