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The United States Food and Drug Administration today took action to improve the quality, safety and effectiveness of sunscreens as part of its implementation of new authorizations for certain over-the-counter (OTC ). In the short term, these new authorities essentially preserve the status quo marketing conditions for these sunscreens. However, the agency today proposed revisions and updates to these requirements related to maximum sun protection factor (SPF) values, active ingredients, broad spectrum requirements and product labeling, among other provisions.

“Sun protection is important for everyone, regardless of your skin tone. Americans can reduce their risk from sun exposure by continuing to use sun protection measures, including broad-spectrum sunscreen with SPF values ​​of at least 15, ”said Janet Woodcock, Acting Commissioner of the FDA. “Today’s activities represent a key milestone in our implementation of new transformative authorities related to over-the-counter drugs that will allow us to continue to ensure that sunscreens are safe and effective for frequent and lifelong use and offer consumers the protection they expect from these products. We are committed to using our new authorities to help significantly advance innovative, safe and efficient options for consumers and secure a strong OTC market. “

The 2020 CARES (Coronavirus Aid, Relief, and Economic Security) Act reformed and modernized the way sunscreens marketed without approved applications are regulated in the United States. , defines the current requirements for the marketing of these over-the-counter sun products. The CARES Act has not changed the scientific standards for determining whether sunscreen can be legally marketed without an approved application. Over-the-counter prescriptions establish the conditions under which the FDA allows certain over-the-counter drugs to be marketed without new approved drug applications, as they are generally recognized as safe and effective (GRASE), provided they comply with all other applicable requirements.

The Deemed Final Order for Sunscreens includes certain active ingredient requirements from the 1999 Monograph Final Regulations for OTC Sunscreen Products, which never came into effect. It also includes the labeling and efficacy requirements of a 2011 Final Labeling and Efficacy Testing Rule.

The Deemed Final Order essentially preserves the pre-CARES status quo marketing conditions for these sunscreens because, prior to the adoption of CARES, sunscreens were marketed on almost identical terms that were outlined in a discretionary enforcement policy. of the FDA. For this reason, the FDA believes that most sunscreens on the market meet the final prescription. This order will remain in effect until the FDA issues another final order revising it.

The CARES Act required the FDA to issue a revised prescription proposal by September 27, 2021. The FDA today announces the availability of the proposed prescription that the Agency is using as an effective bridging tool in its. ongoing review of the appropriate requirements for the OTC. sunscreens marketed without approved applications from the previous regulatory process to this new ordering process.

The provisions of the decree proposed today are therefore essentially the same as those described in the FDA proposed 2019 rule on sunscreens and aim to bring sunscreens marketed without FDA approved applications up to date with the latest scientific advances. to better guarantee consumers access to safe and effective sun protection products. For example, the decree proposes to update the GRASE status for the 16 active ingredients listed in the decree deemed to be final. It also proposes that GRASE dosage forms for use as sunscreens include oils, lotions, creams, gels, butters, pastes, ointments and sticks, and offers GRASE status for aerosol sunscreens, subject to requirements. testing and labeling.

The decree’s SPF and broad spectrum proposals are designed to ensure that consumers have access to sunscreens that provide adequate protection against ultraviolet A (UVA) rays, given the growing body of evidence linking UVA exposure. skin cancer and other harms. The ordinance also offers updates to the way products are labeled to make it easier for consumers to identify key product information.

The agency will review comments on the proposed order submitted during a 45-day public comment period before issuing a revised final order (and considers all comments submitted in a timely manner to the proposed 2019 rule to be subject constructively to the proposed order). The CARES law specifies that the date of entry into force of the revised final decree may not be earlier than one year after its issue.

Broad-spectrum sunscreens with SPF values ​​of at least 15 are just one part of a skin cancer prevention strategy. Other sun protection behaviors include: wearing protective clothing that adequately covers the arms, torso and legs; wear sunglasses and a hat that provides adequate shade to the whole head; and seek shade where possible during periods of maximum sunshine.

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