NA Sun Care Regulatory Updates

basic information and trending topics

question answer
What are the sunscreen regulations in NA?  In Canada, sunscreen products are classified as non-presciption drugs that are regulated under the Natural and Non-Prescription Health Products Directorates Sunscreen Monograph.

In USA, sunscreen products are defined as "over-the-counter" OTC drugs that are regulated by the US Food and Drug Administration.
What UV filters are allowed in the US? Aminobenzoic Acid, Avobenzone (Escalol™ 517 UV filter), Cinoxate, Dioxybenzone, Ensulizole, Homosalate (Escalol™ HMS UV filter), Meradimate, , Octinoxate, Octocrylene (Escalol™ 597 UV filter), Oxybenzone (Escalol™ 567 UV filter), Padimate O (Escalol™ 507 UV filter), Sulisobenzone, Titanium Dioxide, Trolamine Salicylate, Zinc Oxide
Which sunscreens are banned in certain states/cities in the US? 

Hawaii has two bill introductions (Feb 2020 passed House) adding homosalate, octocrylene, and octisalate to the sunscreen ban beginning Jan 1, 2021; and only sunscreen products with active ingredients classified as GRASE may be sold/distributed.

This adds to the existing state bans of the chemicals oxybenzone (Escalol 567) and octinoxate (Escalol 557) in USVI, Hawaii, Key West, Florida, and the Pacific island nation of Palau, plus the bill in Puerto Rico.

What is U.S. FDA’s new proposed rule on sunscreen products and when it will be finalized?

The FDA’s proposed rule is to update regulatory requirements for most sunscreen products in the United States. This action is aimed at bringing nonprescription, over-the-counter (OTC) sunscreens up to date with the latest science to better ensure consumers have access to safe and effective preventative sun care options. Among its provisions, the proposal addresses sunscreen active ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates to how products are labeled to make it easier for consumers to identify key product information. It is anticipated to be finalized by September 2020.

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What does the FDA’s proposed rule state about the sunscreen active ingredient safety?

The proposed rule states that, of the 16 currently marketed active ingredients, two ingredients (Category I) – zinc oxide and titanium dioxide – are generally recognized as safe and effective (GRASE) for use in sunscreens; two ingredients (Category II) – PABA and trolamine salicylate – are not GRASE for use in sunscreens due to safety issues. There are 12 ingredients (Category III) for which there are insufficient safety data to make a positive GRASE determination. To address these 12 ingredients, the FDA is asking industry and other interested parties for additional data.

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What would happen if FDA issues its final monograph on September 2020?

Once the finalized monograph is put into effect, any sunscreen that contains active ingredients that are not in the monograph must go through a New Drug Application (NDA) process. The sunscreen cannot be sold in the United States until it goes through NDA process and gets FDA approval.

Industry can obtain deferrals and continue to sell sunscreens containing Category III active ingredients that are included in the deferrals if industry show satisfactory progress toward completing FDA testing requirements for these ingredients. Otherwise, these sunscreen actives will be banned for sale in the United States.

How can I measure Water and Sweat Resistance for USA market? 

If you want to make water-resistance claims on your labeling in the United States, the water-resistance test in 21 CFR 201.327(i)(7) is required.

Learn more about Ashland ingredients for water resistance

If you need help developing or screening formulas before running in-vivo tests, you can reach out to your sales representative or contact us.

Are sunscreens causing coral reef decline?  No. Scientific evidence does not support a connection between sunscreen ingredients and coral decline. Scientists and credible environmental experts around the world acknowledge that climate change, over-fishing, and sewage runoff cause harm to coral reefs and not sunscreen.

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Do sunscreen ingredients like oxybenzone or octinoxate cause damage to native coral reef?  No. Allegations linking oxybenzone/octinoxate and coral bleaching are based largely on inadequate scientific studies that do not meet required quality controls used by regulatory and scientific research bodies worldwide.

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Are the sunscreens I use on the beach ending up in the environment?

A tiny amount is. In a recent study performed in Hawaii analyzing seawater, sediment, and coral tissues, extremely small amounts (low to mid parts per trillion range) of some sunscreen ingredients were found, while others were not detected. These very low levels detected are the equivalent of adding one drop of an ingredient into a tanker filler with water.

Source: C.L. Mitchelmore et al., Science of the Total Environment 670:398-410.

What is the latest on the FDA? 

The FDA has delayed the statutory deadline of Nov 26, 2019 for finalizing the OTC sunscreen monograph until at least Nov 2020.

The Coronavirus Aid, Relief, and Economic Security Act” (“CARES act”) has been passed and includes OTC monograph reform provisions.


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