The US Food and Drug Administration is planning to toughen the regulatory requirements for almost all sunscreen products.

The primary aim of the FDA’s new proposal is to bring non-prescription, over-the-counter sunscreens marketed without its approval in the US “up-to-date with the latest science”.

According to the FDA, of the 16 currently marketed active ingredients in sunscreens only two ingredients (zinc oxide and titanium dioxide) are GRASE (generally recognised as safe and effective) and two ingredients (PABA and trolamine salicylate) are considered not GRASE while there is  “insufficient safety data to make a GRASE determination” for the remaining 12 ingredients.

Key recommendations in the proposal include:

  • To raise the maximum proposed SPF value on sunscreen labels from SPF 50+ to SPF 60+.
  • To set dosage forms that are GRASE for use as sunscreens include sprays, oils, lotions, creams, gels, butters, pastes, ointments and sticks.
  • To require sunscreens with a SPF value of 15 or higher to also provide broad spectrum protection.
  • To develop new product label requirements that include the addition of the active ingredients and a cancer/skin ageing alert if the sunscreen has not been shown to help prevent skin cancer on the front of the package.

FDA commissioner Scott Gottlieb said the proposal will “improve quality, safety and efficacy of the sunscreens Americans use every day”.

“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,” he said.

“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.

“At the same time, sunscreen formulations have evolved as companies innovated. Today’s action is an important step in the FDA’s ongoing efforts to take into account modern science to ensure the safety and effectiveness of sunscreens.

“We will continue to work with industry, consumers and public health stakeholders to ensure that we’re striking the right balance.”

Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research added that 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 their promises.

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