Protecting Your Sunny Side Up

A Look at FDA’s Regulation of Sunscreen

FDA has regulated sunscreen since the 1970s to ensure that consumers have access to safe and effective sun protection products, but not all sunscreens are created equally! As there have been several developments involving sunscreen regulation in the past few years, we’ll provide an update as to where things are at for businesses looking to understand the regulatory climate, and for consumers looking to stock up on sunscreen products this summer!

In 2019, FDA issued a proposed rule on sunscreens to bring sunscreens up to date with the latest science. Among other items, the proposal aimed to revise the requirements for sunscreen active ingredients, maximum sun protection (SPF) levels, broad spectrum requirements (protection against both ultraviolet A and B rays), and dosage forms (for instance, cream, lotion or spray), and to also update sunscreen labeling.

Then in March 2020, Congress enacted the 2020 Coronavirus Aid, Relief, and Economic Security Act (also known as the CARES Act) in response to COVID-19, which reformed and modernized FDA’s regulation of certain OTC monograph drugs, including sunscreen. See our prior post on the CARES Act as well. To better respond to changing science, the development of new data, and innovation, the CARES Act replaced the rulemaking process for OTC monograph drugs with an administrative order process to issue, revise and amend an OTC monograph. The CARES Act also established deemed final orders for certain OTC monograph therapeutic categories, which became effective in March 2020; sunscreens were lucky to receive both a deemed final order and proposed order, to amend and revise the deemed final order for sunscreens.

But the requirements of the sunscreen deemed final order really just maintain status quo. The deemed final order overall tracks FDA’s sunscreen enforcement policy guidance that was in effect prior to the CARES Act, and establishes the current monograph for OTC sunscreen products. The proposed order proposes changes to these requirements to bring them in line with the current science – when finalized, the proposed order will fully replace the deemed final order with new requirements for sunscreens.

Below is a recap of some of the key differences between the deemed final order and proposed order:

Deemed Final Order	Maximum SPF	Active Ingredients	Broad Spectrum requirements
	No upper limit on SPF values	Makes sunscreens containing 16 specified sunscreen active ingredients GRASE by incorporating the ingredients from the (not in effect) 1999 sunscreen monograph	Does not require broad spectrum testing, but creates an optional broad spectrum labeling claim and broad spectrum testing that is required to include this claim on labeling
Proposed Order	Proposed maximum labeled SPF of 60+ and proposes a maximum on the formulated SPF value of a sunscreen	Proposes GRASE status for sunscreens containing zinc oxide and titanium dioxide; not GRASE status for sunscreens containing aminobenzoic acid, trolamine salicylate (due to data showing safety issues); and not GRASE status for sunscreens containing cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone (due to inadequate safety data)	Proposes a requirement that all sunscreens with SPF values of 15+ satisfy broad spectrum requirements

 

There are also considerations for labeling (e.g. for products that have not been shown to help prevent skin cancer or early skin aging caused by the sun to have an alert elsewhere on the label), final formulation testing and recordkeeping (proposed order requires records to be maintained for one year after product expiry, or if exempt from expiration dating, for 3 years after distribution of the last lot labeled in concert with that testing), and sunscreen-insect repellant combinations (proposed order proposes to classify products as not GRASE).

FDA has advised that if sufficient data becomes available to answer the outstanding questions about whether a sunscreen containing any of the ingredients under review, is GRASE, FDA will move to a final order reflecting the Agency’s conclusion about that ingredient’s status and/or advise that action has been deferred until data is developed and submitted. The FDA will use the administrative order process, as established by the CARES Act, to make decisions on the GRASE status for OTC sunscreen products.

As the jury is still out on the safety of the other sunscreen active ingredients, businesses and consumers should continue to monitor regulatory changes. For manufacturers and businesses seeking to continue the marketing of sunscreen products containing active ingredients for which there is insufficient safety data, manufacturers should provide FDA with additional data on the safety of the active ingredients. And for consumers looking to choose a sunscreen product amongst the developing science and regulation, this means using broad spectrum sunscreen of SPF15 or higher which protects against both types of ultraviolet radiation and against skin cancer and early skin aging, with other sun protection measures, and re-applying sunscreen frequently.

While there is no deadline for FDA to finalize the proposed order, the final order, once issued, will go into effect one year after the date of issuance and will include information regarding the effective date of implementation.

For questions about this article or expert advice and legal and regulatory counsel on OTC Drugs, or FDA regulation, please contact Shelly Garg at shelly@garg-law.com.