WASHINGTON — The FDA proposed updating its current sunscreen regulations on Thursday, and said that two of 16 common sunscreen ingredients — para-aminobenzoic acid (PABA) and trolamine salicylate — are not safe or effective for use.
In its announcement, the agency said only zinc oxide and titanium dioxide are safe and effective, while the safety and efficacy of 12 other common ingredients is unknown at this time.
“To help make sure this effort is successful, the FDA is looking to industry to gather the data needed to help ensure that products marketed to offer protection from the sun’s effects are safe and deliver on these promises,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.
To ensure that sunscreens provide consumers with the protections they expect, the FDA is also proposing requirements that those with a sun protection factor (SPF) value of 15 or higher “also provide broad spectrum protection and that, for broad-spectrum products, as SPF increases, the magnitude of protection against UVA radiation also increases.”
Some of the FDA’s other suggested steps to enhance the safety and efficacy of sunscreens include:
- Limiting high SPF assertions t0 60-plus
- New testing standards to enhance UVA and broad spectrum protection
- Banning the use of insect repellents in sunscreen
- Requiring additional assessment of spray sunscreens to avoid harm from inhalation
- Clearer labels for easier identification of active ingredients, with ingredients listed on the front
- Safety assessment of active chemical ingredients
“After more than 40 years, the FDA is at last taking serious steps to finalize rules that would require sunscreen companies to make products that are both safe and effective,” David Andrews, PhD, of the Environmental Working Group (EWG) said in a press release.
“For a decade, EWG has worked to raise concerns about sunscreens with oxybenzone, which is found in nearly all Americans, detected in breast milk and potentially causing endocrine disruption,” he continued. “Today the FDA recognized those concerns and said oxybenzone and 13 other ingredients are not classified as safe and effective for use.”
During a press call that followed the FDA’s announcement, EWG’s Nneka Leiba, MPhil, MPH, pointed to a list of over 200 recommended, safe sunscreen products that meet the new standards.
“The good news is that those products all have mineral active ingredients, so zinc oxide or titanium dioxide,” Leiba said. “We don’t want people to stop using sunscreens because of this rule, but we want them to choose sunscreens that are safe and effective.”