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04-08-19 | Posted by

Just in time for Spring, the U.S. Food and Drug Administration has issued a proposed rule that would update regulatory requirements for many sunscreen products.This is aimed at bringing nonprescription, over-the-counter (OTC) sunscreens that are marketed without FDA-approvals up to date with the latest science. Their hope is to ensure that consumers understand the criteria for effective sun care options, active ingredients dosage forms, SPF and broad-spectrum requirements.

The FDA also proposes labeling updates to make it easier for consumers to identify key product information. Broad spectrum sunscreens with SPF of at least 15 are considered mandatory for preventing skin cancer and protecting the skin from damage caused by UV rays, yet some of the essential requirements haven’t been updated in decades. Since their initial evaluation, researchers and dermatologists know more about the effects of the sun and the absorption of sunscreens through the skin. Sunscreen usage has changed, with more people using more SPF more frequently. At the same time, sunscreen formulations have advanced as new technologies become available and manufacturers step up their game to compete in a crowded marketplace.

According to dermatologist Jeffrey Dover of Skincare Physicians of Chestnut Hill, MA “America is falling way behind the rest of the Western world in sunscreen development and availability. We haven’t had a newly available sunscreen in the US for over a decade. At the same time, Canada and Western Europe have had several new classes of elegant highly effective broad-spectrum UVB and UVA sunscreens that we brought to the market. Now the FDA is actually looking at restricting even the ones that we presently have. We’re going in the wrong direction and quickly.”

What you need to know about sunscreens

So, the FDA is working with the pharmaceutical and cosmetics companies to improve the quality, safety and efficacy of sunscreens and to come up with new safety data to educate consumers.To that end, they are cracking down on OTC sunscreen drug products (sold in a drugstore or other retailer) under the Sunscreen Innovation Act. This refers to requirements the FDA has established for how these products can be marketed without approved new drug applications because they are generally deemed to be safe and effective (referred to as “GRASE” in FDA terminology).

The Cliff Notes for what the FDA is proposing:

  • The FDA is proposing that for sunscreens marketed without FDA-approval, of the 16 currently marketed active ingredients, two ingredients – zinc oxide and titanium dioxide – are GRASE (considered safe) for use in sunscreens.
  • Two ingredients – PABA and trolamine salicylate – are not GRASE due to safety issues. There are an additional 12 ingredients for which the FDA has requested additional data.
  • Sunscreens they consider to be safe include sprays, oils, lotions, creams, gels, butters, pastes, ointments and sticks.
  • Powders may be eligible for inclusion in the monograph, but additional data is being requested.
  • Wipes, towelettes, body washes, shampoos and other dosage forms are proposed to be categorized as new drugs because the FDA has not received the necessary data yet.
  • They also want to raise the maximum proposed SPF value on sunscreen labels from SPF 50+ to SPF 60+.
  • They may now require sunscreens with an SPF15 or higher to provide broad spectrum protection. For broad-spectrum products, as SPF increases, protection against UVA rays should also increase to provide enough coverage.
  • Products that combine sunscreens with insect repellents are not considered to be GRASE.

Lastly, the FDA proposes new sunscreen label requirements, including the addition of the active ingredients on the front of the package to bring sunscreen in line with other OTC drugs, and notification on the skin cancer/skin aging alert for sunscreens that have not been shown to help prevent skin cancer.

According to New York City dermatologist Jeremy Brauer, “Sunscreens are only one element of a comprehensive skin-cancer prevention strategy. Among the other important sun protective behaviors to follow, wearing sun-protective clothing that covers your arms, chest, torso and legs; wearing UV-protectant sunglasses and a hat that provides adequate shade to the whole head, including your scalp and the tops of your ears; and seeking shade whenever possible when sunlight is at its strongest levels, from 10 AM t0 4 PM.”

Note that until the FDA has made its ruling, the sunscreen products under scrutiny will still be available from the usual retailers.

Here, 5 of our fave SPF50’s finds to try:

La Roche-Posay Anthelios Mineral Sunscreen Gentle Lotion SPF50 With Cell-Ox ShieldA 100% mineral lotion infused with antioxidants and formulated to be extra soothing to protect even the most sensitive skin from UVA/UVB rays.

SUPERGOOP! SPF 50 Sun-Defying Sunscreen Oil with MeadowfoamIf you love the feel of oil on your skin, this lightweight high performing SPF with a silky texture and light citrusy scent is just the ticket for you.

Lancome UV Expert Aquagel Defense Primer + Moisturizer SPF50 – With SPF 50 UVA/UVB protection this cooling and hydrating formula turns into a water-like gel that glides on smoothly under makeup and is invisible.

Replenix UltiMATTE Perfection SPF50+– A cross between a high SPF, primer and a tinted BB cream, this powerful multi-tasker has got you covered with green tea polyphenols, antioxidants A, C, E, CoQ10, Biotin and Zinc Oxide.

Coppertone Glow Sunscreen Lotion with Shimmer SPF 50 On the order of cheap and cheerful, this shimmery sunscreen lotion leaves your skin soft with a sexy glow and is water resistant in SPF 15, 30 and 50, all at a bargain price of $8.99.


NOTE: Replenix and Coppertone were provided for review. All other products were tried in-store. Opinions are my own.


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