FAQs on sunscreen ingredients including proposed rule on the final monograph

 

 Watch a webinar about the FDA's proposed sunscreen rule.

What does the FDA’s recent sunscreen proposal encompass? 
The FDA’s recently proposed rule is the first step in the process to establish a final over-the-counter sunscreen monograph and encompasses which sunscreen ingredients on the market are generally recognized as safe and effective (GRASE), meaning that they can be included in sunscreen products up to a specified concentration.

In addition, the rule makes proposals regarding safety and effectiveness of dosage forms, maximum SPF and broad-spectrum requirements, final formulation testing and recordkeeping, and sunscreen-insect repellent combination products. It also proposes updates to labeling requirements to help consumers identify key product information.

Ingredient safety and effectiveness 
The FDA proposes that two ingredients — zinc oxide and titanium dioxide — are GRASE and that two others— PABA and trolamine salicylate — are not GRASE due to safety concerns. However, these non-GRASE ingredients are not used in sunscreen products currently marketed in the United States.

The FDA proposes that more safety data is required for an additional 12 sunscreen ingredients: 7 that are commonly used in the United States (ensulizole, homosalate, octinoxate, octisalate, octocrylene, oxybenzone, avobenzone) and 5 others that are not currently marketed (cinoxate, dioxybenzone, meradimate, padimate O, sulisobenzone).

Dosage forms 
The FDA proposes that the following dosage forms are GRASE: oils, lotions, creams, gels, butters, pastes, ointments, and sticks.  Sprays will be classified as GRASE provided that necessary testing is performed to minimize risk from unintended inhalation (particle size restrictions) and flammability (flammability and drying time testing). The FDA also expects to require labeling for use of sunscreen spray.

New drug applications (NDAs) are proposed as a requirement for wipes, towelettes, body washes, and shampoos. The FDA needs additional data on their safety and effectiveness and anticipates that powders will have particle size restrictions if finalized as GRASE under the final rule.

Sun protection factor 
The FDA is proposing to raise the maximum labeled SPF value for sunscreen monograph products from the previously proposed 50+ to SPF 60+ based on data showing additional clinical benefit provided by SPF 60 sunscreens that also provide broad-spectrum protection. The FDA also proposes that to pass the broad-spectrum test, a sunscreen product must show that it provides a UVA I/UV ratio of 0.7 or higher.

The proposed rule also notes a concern about consumers understanding of relative efficacy. The found a lack of clinical data showing meaningful efficacy differences between closely grouped SPF values and variability inherent in a clinical test that relies on visual assessments (tested SPF and determined SPF values). In addition, the proposed rule states that variability in SPF values is increased in high SPFs. To avoid misleading consumers about relative efficacy, The FDA proposes requiring sunscreen monograph products be labeled with an SPF number corresponding to the lowest number in a range of tested SPF results. For example, a sunscreen that tests at an SPF 38 within the 30 – 39 range would be labeled SPF 30 

Sunscreen-insect repellant combinations 
The FDA proposes that sunscreen-insect repellent combination products are not GRASE due to incompatibilities between the FDA and Environmental Protection Agency (EPA) labeling requirements. Also, data suggests that combining certain sunscreen ingredients with diethyltoluamide (DEET) may increase ingredient absorption.

Why is the FDA requesting safety data on sunscreen ingredients already used in sunscreen products on the market in the United States? Why is the FDA concerned about these sunscreen ingredients? 
In explaining the agency’s reasoning behind the proposed rule, the FDA has cited increased frequency and amount of sunscreen used. The FDA wants to know to what extent human skin absorbs sunscreen ingredients and whether or not that results in any negative impact on human skin or body. However, the FDA has been clear that by requiring these data they are not expressing concern nor have they concluded that these ingredients are unsafe.

The FDA recently published a small preliminary study in JAMA, which found the application of four commercially available sunscreens under maximal usage trial (MUsT) conditions resulted in plasma concentrations that exceeded the threshold established by the FDA for requiring non-clinical toxicology studies. The study did not evaluate the safety of the ingredients and the study authors noted more research is needed before it can be determined if the absorption of sunscreen ingredients has any negative effect on a person’s health. Importantly, they also stated that individuals should continue to use sunscreen.

What is the OTC sunscreen monograph?
The FDA’s OTC Drug Review process evaluates the safety and effectiveness of OTC drugs marketed in the United States before May 11, 1972 and establishes conditions for which an OTC drug is considered GRASE and may be marketed without first undergoing a new drug application approval. These finding are published in a document called a monograph. Products utilizing ingredients, dosage forms, and labeling included in the final OTC sunscreen monograph can go directly to market.

Once the monograph is finalized and put into effect, any sunscreen that does not meet the conditions of the monograph or has not received approval of its New Drug Application (NDA) should not be marketed in the United States.

Why are sunscreen products regulated by the Food and Drug Administration (FDA) as ‘drugs’ in the United States?
The federal Food Drug and Cosmetic Act and the FDA regulations define the term drug, in part as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease”. Since sunscreen products are intended to prevent skin cancer they meet this definition and are regulated as OTC drugs.

What safety testing is the FDA requiring?
The FDA is asking for safety data regarding:

  1. Skin irritation and/or allergic reaction when applied or when exposed to light.
  2. The extent of which the ingredients are absorbed through the skin into the body.
  3. Whether the ingredient would be considered generally safe and effective in children.
  4. Whether the ingredient would cause tumors of the skin or rest of the body with long-term use.
  5. Whether the ingredient would cause tumors systemically over long-term use.
  6. Whether the ingredient would cause detrimental reproductive or hormonal effects over long-term use.
  7. Whether the ingredient passes a toxicity text in animals to determine a safety margin for humans.

When will this rule go into effect?
The FDA is currently accepting comments on its proposed rule (until May 28, 2019), which it will consider before publishing a final rule. November 26, 2019 is the FDA’s deadline to issue the final rule, according to the Sunscreen Innovation Act. However, FDA officials have stated that they will allow extensions for stakeholders who submit requests during the 90-day comment period if they have a plan in place to submit the safety data and achieve acceptable milestones.

What about the sunscreen products with active ingredients that are not allowed to be marketed in the United States that are sold in Europe and elsewhere abroad?
Industry has applied for eight additional ingredients to be used in sunscreens that use the monograph process, and the FDA had previously required the same safety data for these pending ingredients that they are requiring for the 12 ingredients in the proposed rule. 

In addition to the monograph process, industry can also use the new drug application (NDA) process, which allows confidentiality and exclusivity for their specific product formulations, an abbreviated new drug application (ANDA) or a prescription (Rx)-to-OTC switch.

What is the AADA doing?
Access to sunscreen products has been an advocacy priority of the AADA for many years. The AADA supported the passage of the 2015 Sunscreen Innovation Act, which sought to bring currently unavailable sunscreen products to the market faster. On an ongoing basis the Academy monitors federal, state, and local legislative and regulatory activity that affects access to safe and effective sunscreen products for patients and the public. 

The Academy has appointed an Ad Hoc Task Force, which is analyzing the proposed rule and will be advising the Regulatory Policy Committee on the AADA’s comment letter and other advocacy actions. We continue to be in communication with the FDA and industry about the issues at hand and will continue to update the general membership as developments are made.

What can I do?
The most crucial thing all dermatologists can do is continue to educate patients on safe sun protection behaviors. May is Skin Cancer Awareness Month, and sun protection will be trending in the news and on social media.
The FDA has indicated that they continue to encourage the public to use sunscreen. The Academy encourages sun safe behaviors in its public communications and recommends you: 

  1. Seek shade when appropriate, remembering that the sun’s rays are strongest between 10 a.m. and 2 p.m. If your shadow is shorter than you are, seek shade.
  2. Wear protective clothing, such as a lightweight long-sleeved shirt, pants, a wide-brimmed hat and sunglasses, when possible.
  3. Generously apply a broad-spectrum, water-resistant sunscreen with an SPF of 30 or higher. Broad-spectrum sunscreen provides protection from both UVA and UVB rays.

The AAD has patient friendly information on sunscreen use and effectiveness and sun safe behaviors as well as a patient friendly FAQ on sunscreen safety and what the recent proposed rule means This information is available at www.aad.org/sunscreen.  

Its important that patients understand that the FDA has not determined that any specific sunscreen ingredients currently used in sunscreen products in the United States are unsafe. 

You can also read the proposed rule and submit comments on regulations.gov.