U.S. FDA proposes new regulations for over-the-counter sunscreens

(Reuters) – The U.S. Food and Drug Administration said on Thursday two of the 16 currently used main chemical ingredients in over-the-counter sunscreen products are considered safe, as part of a proposal here aimed at improving the safety and quality of sunscreen products sold without prescription in the United States.

FILE PHOTO: A man is sprayed with sunscreen at the Coachella Valley Music and Arts Festival in Indio, California April 11, 2015. REUTERS/Lucy Nicholson

The agency named two ingredients — PABA and trolamine salicylate — as not permitted for use in non-prescription sunscreen products, adding that it is asking the industry for additional data on 12 other ingredients.

The health regulator said the proposed rule has been issued to establish conditions under which some sunscreen drug products can be sold without FDA-approved marketing applications.

The agency proposed that of the 16 currently used ingredients, only two — zinc oxide and titanium dioxide — are considered safe and effective based on available data.

In November 2016, the FDA had issued here guidelines detailing the data that makers of over-the-counter sunscreens need to produce to prove the ingredients in the products are safe and effective.

“Broad spectrum sunscreens with SPF values of at least 15 are critical to the arsenal of tools for preventing skin cancer and protecting the skin from damage caused by the sun’s rays, yet some of the essential requirements for these preventive tools haven’t been updated in decades,” FDA Commissioner Scott Gottlieb said.

Among other measures, the agency also plans to raise the maximum proposed sun protection factor or SPF value on sunscreen labels from SPF 50+ to SPF 60+.

SPF is a measure of the extent of protection a product offers against the ultraviolet radiation in sun rays, that is generally considered harmful.

Environmental Working Group (EWG), a nonprofit health and environmental advocacy group, called the proposal a “big step toward cleaning up a largely unregulated industry”.

“We expect many companies to quickly reformulate to avoid those ingredients that the FDA considers unsafe or for which there is not enough data to prove safety,” Scott Faber of EWG said on a press call after FDA’s announcement.

Reporting by Manogna Maddipatla in Bengaluru; Editing by Shounak Dasgupta

Our Standards:The Thomson Reuters Trust Principles.

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