U.S. Food & Drug Administration 

10903 New Hampshire Avenue

Silver Spring, MD 20903

www.fda.gov

FDA FACT SHEET

FDA PROPOSED ORDER: SUNSCREEN DRUG PRODUCTS FOR OVER-THECOUNTER-HUMAN USE; PROPOSAL TO AMEND AND REVISE THE DEEMED 

FINAL ORDER ESTABLISHED BY THE CARES ACT 

On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law. Through provisions 

in new section 505G of the Federal Food, Drug and Cosmetic Act (FD&C Act), the CARES Act established and put into effect as 

of that date a Deemed Final Order (DFO) that sets forth certain current requirements for OTC sunscreen products. Sunscreens 

that conform to these DFO requirements (and to other requirements specified by section 505G of the FD&C Act, including the 

general requirements for nonprescription drugs) can be legally marketed without an approved new drug application. The CARES 

Act also directs FDA to amend and revise the DFO for OTC sunscreens products. Accordingly, FDA issued a proposed order that, 

if finalized, would replace this sunscreen DFO in its entirety with new conditions under which nonprescription sunscreen drug 

products would be determined to be generally recognized as safe and effective (GRASE). The proposed order also sets forth 

certain characteristics that would establish that a sunscreen drug product is not GRASE.

This action is an important example of FDA’s ongoing efforts to ensure that sunscreens are safe and effective for regular, lifelong use. The agency anticipates these changes will improve the quality, safety, and efficacy of sunscreens Americans use every 

day. FDA will continue to work with industry and public health stakeholders to make sure that consumers have access to safe 

and effective sunscreens.

1. Proposed GRASE Status of Active Ingredients Listed in the Deemed Final Order

FDA has proposed the following categories for the 16 sunscreen monograph ingredients.

GRASE* for use in sunscreens Not GRASE** for use in sunscreens 

because of safety concerns

***Not GRASE for use in sunscreen 

because additional data needed

Zinc oxide and titanium dioxide Aminobenzoic acid (PABA) and 

trolamine salicylate

Cinoxate, dioxybenzone, ensulizole, 

homosalate, meradimate, octinoxate, 

octisalate, octocrylene, padimate 

O, sulisobenzone, oxybenzone, 

avobenzone

*GRASE= Generally Recognized as Safe and Effective, when also in conformity with all other applicable requirements **These ingredients are not currently 

marketed. ***For ingredients in this category, FDA’s proposed order identifies additional data that, if provided, might establish that sunscreens with these 

ingredients are GRASE.

2. Proposed Requirements Related to Dosage Forms 

FDA is proposing sunscreen oils, lotions, creams, gels, butters, pastes, ointments, and sticks as GRASE. FDA proposes that 

spray sunscreens are also GRASE, subject to proposed testing to minimize potential risks from unintended inhalation (particle 

size restrictions) and flammability (product flash point and drying time testing), together with related labeling requirements. We 

are proposing that there is insufficient data to classify sunscreen in the powder dosage form as GRASE and expect that powders 

would be subject to particle size restrictions if found to be GRASE for sunscreen use in a final order. Finally, we note that, by 

operation of section 505G(m)(2) of the FD&C Act, sunscreens in all dosage forms other than the 10 dosage forms identified 

above currently require an application approved under section 505 in order to be marketed. (Sunscreens in dosage forms that 

require an NDA in order to be marketed include, for example, wipes, towelettes, body washes, and shampoos). The proposed 

order does not propose to change this requirement.
U.S. Food & Drug Administration 

10903 New Hampshire Avenue

Silver Spring, MD 20903

www.fda.gov

3. Proposed Maximum Sun Protection Factor and Broad Spectrum Requirements 

FDA had previously proposed (in 2011) that the maximum permissible labeled SPF value be SPF 50+. Because evidence shows 

additional meaningful clinical benefit associated with broad spectrum SPF 60 sunscreens, FDA is now proposing that the 

maximum labeled SPF value should be SPF 60+. While our proposed cap for SPF labeling is SPF 60+, we are proposing to permit 

the marketing of sunscreen products formulated with SPF values up to 80 (this formulation margin is intended to more fully 

account for the range of variability in SPF test results, among other things). We are proposing not to allow the marketing (without 

an approved NDA) of sunscreen products with SPF values above SPF 80. We are also proposing to require that sunscreens with 

SPF values of 15 or above be labeled with an SPF corresponding to the lowest number in a range of tested results. For example, 

sunscreens testing at SPF 15-19 would be labeled “SPF 15”. This change would help ensure that there is a meaningful difference 

among labeled SPF values and better account for the range of variability in SPF test results. 

In addition, the body of scientific evidence linking UVA exposure to skin cancers and other harms has grown significantly in 

recent years. To address this concern, FDA is proposing: 

• To require that all sunscreens with SPF values of 15 and above satisfy broad spectrum requirements. 

• To add a requirement to the current broad spectrum test to ensure that as SPF increases, broad spectrum protection also 

increases, and that broad spectrum products provide adequate protection against UVA. 

FDA is seeking comment on whether SPF 2-14 sunscreens should remain on the market. They have not been demonstrated to 

help reduce the risk of skin cancer and early skin aging when used as directed with other sun protection measures, and we are 

not proposing to require that they pass the revised broad spectrum test. 

4. Proposed Principal Display Panel (PDP) Labeling Requirements 

To help make it easier for consumers to choose the sunscreen that best fits their needs and understand what type of skin 

protection each sunscreen offers, we’re proposing labeling changes: 

• To include an alphabetical listing of active ingredients, followed by “Sunscreen” and dosage form (such as lotion or spray). 

• For sunscreens with an SPF below 15, we are proposing to require the SPF statement be followed by asterisk directing 

consumers to see the “Skin Cancer/Skin Aging alert” in the Drug Facts Label. 

• To revise format requirements for the SPF, broad spectrum, and water resistance statements on the label to ensure they 

are prominent. 

5. Proposed Requirements Related to Final Formulation Testing Processes and Recordkeeping 

We are clarifying our expectations for testing and record keeping by entities that conduct sunscreen testing. To ensure that FDA 

can assess industry compliance with applicable requirements, we propose: 

• To require that records of required final formulation testing of sunscreens be maintained for 1 year after the product 

expiration date, or, if the product is exempt from expiration dating (as most sunscreens are), for 3 years after distribution 

of the last lot labeled in reliance on that testing. 

• To require industry to keep records of sunscreen formulation testing and clarify that required records would be subject to 

FDA inspection. 

• Other requirements designed to clarify FDA expectations about clinical final formulation testing processes and to ensure 

that sunscreen testing is conducted in a way that both protects human subjects and produces reliable results. 

6. Proposed Status of Sunscreen-Insect Repellent Combination Products 

Sunscreen-insect repellent combination products are proposed as not GRASE because incompatibilities between instructions 

for use for sunscreens and insect repellents prevent these products from being labeled in a manner that sufficiently ensures 

safe and effective use of the sunscreen component.