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New FDA Regulations For Sunscreen

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By Editorial Team

3 min read

Yes, you can still wear the sunscreen you have in your cabinet. In fact, you SHOULD still wear the sunscreen you have in your cabinet. Wearing sunscreen is an important step in preventing skin damage from the sun. Future updates are proposed to benefit consumers since the current regulations governing the manufacturing, labeling, and use of sunscreen have not been revised in years.

New FDA sunscreen regulations

The United States Food and Drug Administration (FDA) announced on February 21, 2019 the proposal of new regulations for over the counter (OTC) sunscreens. They incorporate recent scientific and safety information. The guidelines look at the safety of common sunscreen ingredients, the forms they come in, sun protection factor (SPF), and broad-spectrum requirements (the ultraviolet rays that can cause sun damage). The proposal has been made available for public review and comments for 90 days.1,2 This effort highlights the nonprescription, OTC sunscreens that have been marketed without FDA-approved applications. What does this mean? That the FDA wants to make sure sunscreen requirements will incorporate scientific findings so as to make available to consumers the safest and most effective sun protection choices.2

The history of the FDA and suncreen

The Sunscreen Innovation Act (SIA) was enacted on November 26, 2014. It provided an alternative process to the traditional FDA review of safety and effectiveness of nonprescription sunscreen active ingredients. The FDA is now seeking to collect additional safety data on more than a dozen ingredients it may not classify as safe and effective.2

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More options for sunscreen

With advancements in science and technology researchers and physicians, including dermatologists, pathologists, and oncologists have learned more about the effects of the sun on the skin and about how sunscreen is absorbed. This has led to a broader choice of options to use for preventing skin cancer and protecting the skin from damage caused by the sun’s rays,2 The American Academy of Dermatology recommends sunscreen products that are water-resistant, have broad-spectrum protection, and an SPF of at least 30.

FDA reviews of sunscreen

OTC sunscreens that have not gone through the approval process, and which contain specified active ingredients, will be subject to labeling and testing requirements. Some ingredients and formulations currently in sunscreens will continue to be marketed without new drug approvals, including zinc oxide and titanium oxide. The FDA uses the term “dosage forms” for sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks. The FDA uses the acronym GRASE to describe established ingredients accepted and generally recognized as safe and effective that therefore do not require FDA approval.2

The many varieties of sunscreen products currently contain 16 different marketed active
ingredients.2 Of those:

  • 2 ingredients – zinc oxide and titanium dioxide – are GRASE for sunscreens.
  • 2 ingredients – PABA and trolamine salicylate – are not GRASE for use in sunscreens due to safety issues.
  • 12 other ingredients – don’t have enough safety data and the FDA has asked for more data.

The FDA is asking the sunscreen industry for additional data based on specific issues presented in the guidance. It has also requested additional testing of powders. Wipes, towelettes, body washes, shampoos, and other dosage forms would be considered new drugs and have to go through the approval process. Sunscreens currently manufactured with insect repellents would also be considered new drugs.2

Proposed New Requirements in Product labeling, SPF value and spectrum:2

  1. Provide enough information to ensure consumers receive the protections they expect.
  2. Require sunscreens with an SPF value of 15 or higher to also provide broad-spectrum protection. For broad-spectrum products, as SPF increases, level of protection against UVA radiation also increases.
  3. Raise maximum SPF labeling from 50+ to 60+, based on new evidence of clinical benefits for additional SPF.
  4. Clarify new sunscreen product label requirements.
  5. Add active ingredients to the front of the package like other OTC drugs.
  6. Add disclaimer on front label regarding sun exposure and associated risk for premature aging of the skin. Include that UVB rays are associated with skin cancers and sunburns.

Ensuring safety

FDA Commissioner Scott Gottlieb, M.D. (who announced his resignation as of April 2019) said the agency is taking advantage of advances in modern science to ensure the safety and effectiveness of sunscreens.

Product reform

As this review and development of new rules moves forward, sunscreen products will continue to be available on the market. The FDA supports the position that sunscreens are only one element of a skin-cancer prevention strategy. Additional protective actions include wearing protective clothing that adequately covers arms, torso and legs; wearing sunglasses and a hat to shade to the whole head; and staying out of the sun whenever possible during peak periods.2

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