NA Sun Care Regulatory Updates

basic information and trending topics

question answer
How are sunscreens regulated in North America?  In Canada, sunscreen products are classified as non-presciption drugs that are regulated under the Natural and Non-Prescription Health Products Directorate 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
  • Cinoxate
  • Dioxybenzone
  • Ensulizole
  • Homosalate
  • Meradimate
  • Octinoxate
  • Octocrylene
  • Oxybenzone
  • Octisalate
  • Padimate O
  • Sulisobenzone
  • Titanium Dioxide
  • Trolamine Salicylate
  • Zinc Oxide
Are any sunscreens banned in the US? 

Yes, the following UV filters are subject to bans in the specified localities.

  • oxybenzone:US Virgin Islands, Hawaii, Florida, Puerto Rico
  • octisalate: Hawaii
  • octinoxate:US Virgin Islands, Hawaii, Florida, Puerto Rico
  • homosalate: Hawaii
  • octocrylene: Hawaii 

note: Maui county, Hawaii permits only mineral sunscreens

What is the U.S. FDA's current rules/guidance on sunscreen products?

The FDA issued the Deemed Final Order outlining sunscreen requirements in 2021. A new proposed order is currently under advisment. Additional detail on both the Deemed Final Order and the new proposed order can be found below. 

Deemed Final Order: FDA published OTC Monograph M020 on 9/24/2021 Titled: Susnchreen Drug Products for Over-the Counter Human Use. The deemed final order for sunscreens includes certain requirements about active ingredients from the 1999 final monograph regulation for OTC sunscreen products, which never took effect, and the labeling and effectiveness requirements from a final 2011 labeling and effectiveness testing rule.

In addition to incorporating requirements already in effect under the final 2011 regulation, the deemed final order largely corresponds to the approach of an FDA sunscreen enforcement policy guidance, which had been in place before the CARES Act because the sunscreen monograph was not in effect.

Proposed Order OTC000008:  This new proposed order proposes changes to the requirements  outlined in the Deemed Final Order with the intent of bringing them up to date with the current science. When finalized, the proposed order will fully replace the deemed final order with new requirements for sunscreens.

What test methodology is required to make water/sweat resistance claims in the US 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.

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 harmful to coral reefs?  No. Scientific evidence does not support a connection between sunscreen ingredients and coral decline. 


learn more about Ashland sun care solutions >





Read More >