US regulation of sunscreen products

Can dsm-firmenich’s PARSOL® Shield become first UV filter approved in over 20 years?

No UV filters have been approved by the FDA for use in cosmetics since 1999. In this blog we will examine the causes for this 20-year delay, and discuss the work being done by dsm-firmenich to achieve US approval for our broad-spectrum UVA and UVB filter, bemotrizinol (BEMT) – also known as PARSOL® Shield.

In 1999, a final OTC Sunscreen Monograph was released for non-prescription over-the-counter (OTC) sunscreen drug products. This described the conditions under which OTC Sunscreen Monograph products would be generally recognized as safe and effective (GRASE) (see our past article on ‘Defending UV filters under the FDA Sunscreen Monograph’).

In 2019, the FDA issued a Tentative Final Monograph (TFM), proposing new testing requirements for sunscreen ingredients according to their assessment of changing patterns of sunscreen use, which indicated more frequent use over longer periods of time. In 2020, the Coronavirus Aid, Relief, and Economic Security (CARES) Act meant that the FDA was required to reform the OTC drug approval process. This resulted in the FDA issuing a new proposed order (PO) for sunscreens, which included the requirements specified in the 2019 TFM.

As part of OTC reform, the FDA stayed the 1999 final OTC Sunscreen Monograph until the PO is finalized. The FDA also created a provision for deferring several sunscreen active ingredients, which the industry are currently supporting from a safety perspective, from the final PO. As part of the 2021 PO, the FDA indicated that the ingredients being supported by industry would be allowed to be marketed as long as progress was being made with regard to completion of the studies needed for the FDA to make a GRASE determination.

Here we provide a breakdown of what the GRASE and CARES acts mean for sunscreen products, including the conditions for active ingredients and labelling, SPF claims, and broad-spectrum requirements.

We then introduce sunscreen active BEMT, which, despite being used globally as a UV filter for many years, is not currently available in the US. In fact, only 16 UV filters are currently approved for use in the US, compared with 27 in the EU. We will discuss our journey and current progress with the FDA in sponsoring BEMT for inclusion under the Sunscreen Monograph as GRASE, with the potential for it to become the first UV filter to be approved in the US since 1999.

The FDA proposed order for sunscreens

OTC Sunscreen Monograph: Regulatory processes

In the US, sunscreens are regulated as OTC drugs by the FDA and must be GRASE approved before they can be used in sun protection products. With the introduction of the new CARES Act in 2020, a number of additional regulatory processes thereby came into play for the approval of UV filters.

What stayed the same?

• Ingredient-based review
• APIs grouped by therapeutic categories
• GRASE (generally recognized as safe and effective) determination
• No FDA pre-approval
• Public comment period

What was new?

• Administrative Order (AO) process
• OTC Monograph Order Request (OMOR)
• Existing OTC Monograph and ingredients require transfer to AO
• Exclusivity provisions for innovation
• OTC Monograph User Fee (OMUFA)
• Minor changes in dosage form provisions
• Confidential information and formal meetings with FDA

OTC Sunscreen Monograph: UV filter safety, effectiveness, and labelling requirements 

The FDA’s 2021 PO specifies requirements for all key parameters responsible for sunscreen safety and effectiveness, as well as specific labelling requirements to improve consumer product awareness (Fig. 1). 

GRASE determination for active ingredients: Active ingredients are held accountable by GRASE determination. Based on new data requirements, of the 16 currently approved OTC active ingredients for sunscreens, only two – zinc oxide and titanium oxide – are now recognized as GRASE.
Further data is required for the remaining active ingredients to attain GRASE status. If this data cannot be provided, those active ingredients will be eliminated from use in the US market. One-year renewable deferrals are possible if progress is made to support the safety of the not-GRASE filters, but the additional clinical and non-clinical safety studies required are extensive.

Positive listing of permitted active (API) and inactive ingredients: Until the FDA’s 2021 PO is finalized, all OTC sunscreen products subject to the FDA 1999 sunscreen final rule must comply with the 2011 regulations on labeling and SPF as indicated in 21 CFR 201.327 and bear specific labelling to promote their safe and effective use, including clear labelling with information on concentrations, indications, directions, and conditions of use.

Dosage forms: Oils, lotions, creams, gels, butters, pastes, ointments, sticks, sprays, or powders are allowed. However, GRASE status for spray sunscreens is subject to testing and labelling requirements, and additional data are needed for GRASE determination for powders. The final order does not propose categorical classification of sunscreen products manufactured using nanotechnology (or containing nanomaterials) as GRASE or not GRASE.

Broad-spectrum claims: To address the growing evidence of significant harm associated with UVA exposure, the PO states that all sunscreens with SPF values of 15 and above should satisfy broad-spectrum requirements. This includes a proposed new requirement that broad-spectrum products meet a UVA1/UV ratio of 0.7 or higher.

SPF claims / maximum SP: The PO does not include a limit on maximum SPF values, but proposes that the maximum labelled value should be SPF 60+. However, it permits marketing of sunscreen products formulated with SPF values up to 80.

Water resistance: Sunscreen drug products are to be defined and clearly labelled as providing 40 or 80 minutes of water resistance, according to the test in 21 CFR 201.327.

Specific requirements for labels and packaging (21CFR201.327): There are also proposed changes to improve consumer awareness of important information on sunscreen labels, including:

• Addition of an alphabetical listing of the sunscreen active ingredients in the product, followed by “sunscreen” and the product’s dosage form (e.g. “lotion” or “spray”).
• Sunscreen products that have not been shown to help prevent skin cancer or early skin aging caused by the sun will be required to include an asterisk (*) after the SPF statement to direct consumers to see the “Skin Cancer/Skin Aging alert” elsewhere on the label.
• To prevent required information from being obscured or overwhelmed by other labelling features, the required formatting of the SPF, broad-spectrum and water resistance statements on the label are being revised.

Bemotrizinol – PARSOL® Shield

Bemotrizinol (BEMT) is a photostable broad-spectrum filter that efficiently provides UVA and UVB protection even at low concentrations. DSM has been providing BEMT under the trade name of PARSOL® Shield as a UV light absorber for use in sunscreens and personal care cosmetic products since 2016. It is easy to use and compatible with both organic and inorganic UV filters. 

However, despite being used globally since 1999, BEMT is not approved for use under the OTC Sunscreen Monograph. Its approval would be of great benefit in the face of the changing regulatory conditions that threaten the use of 14 of the 16 UV filters currently used in the US, which could significantly limit sun protection options for formulators and consumers alike. 

At DSM, we believe that it is crucial for consumers in the US to be able to benefit from the broad-spectrum UV protection and sensory properties that modern filters such as BEMT can provide. Access to UV filters such as BEMT helps protect skin health and prevent skin cancer, which is on the rise in the US. We are therefore sponsoring BEMT for inclusion under the Sunscreen Innovation Act at a maximum concentration of 6%.  

We have met with the FDA and are investing significant effort and resources into the regulatory process. We are committed to gathering the appropriate safety and toxicology data needed to provide the necessary support for the FDA’s review of BEMT and to determine the compound under GRASE – regardless of time and cost (Fig. 2).