FDA To Update Sunscreen Regulations


One in five Americans will develop skin cancer in his or her lifetime, but that risk can be minimized with the use of sunscreen. While sunscreen use has increased over the years, the U.S. Food and Drug Administration (FDA) hasn’t updated some sunscreen requirements in decades. Now, a proposed FDA rule seeks to improve the quality, safety and effectiveness of sunscreens.

Safety of Some Sunscreen Ingredients in Question

The FDA currently lists just two of the existing 16 sunscreen ingredients as safe and effective:

  • Zinc oxide
  • Titanium dioxide

Under the new rule, two ingredients will no longer be considered safe and effective:

  • PABA (para-aminobenzoic acid), which may not block the damage caused by UV light and may cause skin irritation or inflammation
  • Trolamine salicylate, which may cause nausea, vomiting and ringing in the ears and other negative health effects, such as bleeding

The FDA hasn’t definitively decided whether the 12 remaining ingredients are safe and effective, so the agency has requested additional information through the proposed rule change. In the meantime, choosing sunscreens with zinc oxide or titanium dioxide is the safest choice.

New Options for Sun Protection May be Coming

Some products may be better at filtering UV light and preventing skin cancer. But because they haven’t been through the FDA process, they are not available in the U.S. Instead, they are available to residents of:

  • Canada
  • Australia
  • Japan
  • European countries

As part of the rule change the FDA is accepting comments including the safety and efficacy of potential new over-the-counter sunscreens. Companies who conduct FDA-required testing on newer sunscreens may now get a hearing and go through the FDA process. As a result, Americans may soon gain access to improved sunscreens.

New Sunblock Requirements

The new FDA proposal recommends raising the maximum sun protection factor (SPF) in sunscreen from 50+ to 60+. While this could potentially mean greater protection, the American Academy of Dermatology Association suggests an SPF of 30 will block 98 percent of sun rays.

The proposed new rule has not evaluated wipes and towelettes with sunscreen —instead they will be considered new drugs and have to go through the approval process — but does consider sunscreen safe in these forms:

  • Oils and butters
  • Lotions and creams
  • Gels and pastes
  • Ointments and sticks

The FDA will also require combination sunscreen/insect repellant products to go through the approval process.

The ultraviolet (UV) spectrum contains both UVA (long-wave) and UVB (short-wave) rays. Because skin cancer risks are increased with UVA exposure, the FDA proposes that all sunscreen products with an SPF of 15 or higher now provide broad-spectrum (UVA and UVB) sun protection. They are considering whether to keep sunscreens with SPF of 2 to 14 available to consumers.

If you want to learn more about skin cancer prevention contact UCLA Dermatology at 310-825-6911. UCLA also offers expert care for people diagnosed with skin cancer in the Melanoma Clinic.