Bemotrizinol (BEMT) has been commonly used as a sunscreen agent in Europe, Japan, and many other countries for over 20 years. In September 2024, DSM Nutritional Products, LLC, submitted an OTC monograph order request to add BEMT at concentrations up to 6% as a new active ingredient for OTC sunscreens. On June 9, 2026, the FDA publicly announced the addition of 6% BEMT to the OTC sunscreen monograph and issued a final order on June 10.^1,2

BEMT provides broad-spectrum protection against ultraviolet A (UVA) and ultraviolet B (UVB).^1,3 It has minimal systemic absorption, rarely exceeding the FDA threshold of 0.5 ng/mL.³ It is also the first new sunscreen active ingredient evaluated by the FDA using the Generally Recognized As Safe and Effective (GRASE) testing standards for use in ages 6 months and older.¹ BEMT is expected to be available in the US in late September 2026 under the brand name Parsol Shield.

Impacts of Sunscreen Use

In the US, skin cancer is the fifth most common cancer, with over 5 million cases diagnosed annually. The annual incidence rate of skin cancers continues to rise, with rates tripling since 1975 (8.8 cases per 100,000 people) compared to 2023 (28.3 cases per 100,000 people), with an estimated 112,000 new cases in 2026.^3,4 It is well known that sun exposure plays a significant role in skin cancers, including melanoma. The daily use of broader and more stable advanced sunscreen filters, such as BEMT, will contribute to improving public health and potentially reducing skin cancer prevalance.³

The sun emits UVA, UVB, and UVC radiation. The ozone layer absorbs UVC and part of UVB, with UVA being the most common form of UV radiation, followed by UVB. UVA has a longer wavelength of 315 to 400 nm, allowing it to penetrate the dermis layer of the skin, which can contribute to aging. UVB has a shorter wavelength, ranging from 280 to 315 nm, and primarily affects the epidermis layer, where it is responsible for sunburn. Both UVA and UVB can result in the potential development of skin cancer with prolonged exposure.^3,5

BEMT is an organic broad-spectrum agent that protects against UVA and UVB radiation, with absorption peaking at 310 nm and 340 nm.^3,6 Different absorption spectrum filters are often combined to create broad-spectrum UV coverage.⁷ Although UV radiation is often associated with skin damage, limited exposure to UVB radiation is beneficial as it stimulates vitamin D3, allowing the body to absorb calcium and phosphorus, which are essential for bone and muscle health.⁵

Types of Sunscreens

In the US, sunscreen use has increased from 69% in 2015 to 75% in 2024. Furthermore, sunscreen unit sales increased from 153,870,186 in 2011 to 161,882,779 in 2016, indicating a 5.21% increase in sunscreen sales over 5 years.³

Sunscreens can be separated into 2 categories: inorganic (mineral) or organic (chemical) UV filters. Inorganic filters include zinc oxide (ZnO) and titanium dioxide (TiO2), which act as sunscreens by scattering, reflecting, and absorbing light. However, their use is limited due to their chalky, white appearance on the skin, which may be aesthetically unacceptable to some users. Organic UV filters absorb UV radiation and release small amounts of heat, and they are often combined with photostability agents to improve formulation stability.^6,7 Photostability refers to a sunscreen’s ability to retain protective properties from sunlight without undergoing photodegradation and loss of efficacy.

The FDA approves sunscreens through either an OTC drug monograph process or through a new drug application (NDA). Sunscreens that were not in use before the inception of the OTC drug review are not eligible for approval through the OTC drug monograph process. Drugs that are considered GRASE are not required to go through an NDA.³ All 17 filters currently approved for sunscreen use under the OTC monograph system are classified into 1 of 3 categories, as shown in Table 1.^2,3

BEMT has been added to the Category I (GRASE) sunscreen OTC drug monograph and approved in the following dosage forms: oil, lotion, cream, gel, butter, paste, stick, and spray (with no propellant or isolated from propellant).^2,3 It also has a large structure, high molecular weight, and low photosensitivity potential, which may limit dermal penetration and systemic absorption due to its unique characteristics.^3,6

Environmental and Adverse Effects of Sunscreen Usage

Under the guidance of the National Environmental Policy Act of 1969, the FDA reviewed BEMT 6% for environmental impact as submitted by DSM Nutritional Products, LLC, and found that there was no significant impact based on the environmental assessment.^2,8 Sunscreen endocrine disruption, especially for oxybenzone and homosalate, has also been a consumer concern. However, studies of BEMT in rats have found that it did not provide a positive response to either androgen or estrogen receptor competitive binding assays, indicating no hormonal effects.³

Two commonly observed adverse effects of sunscreen usage in clinical studies are photoallergy and phototoxicity. Adverse effects are primarily related to the formulation of sunscreen and the UV filter(s) used. Photoallergy is a type 4 delayed hypersensitivity reaction that occurs after prior sensitization, in which UV light activates a chemical into a reactive species that binds to dermal proteins. Clinical symptoms include wheal, flare, dermatitis, edema, and vasodilation with onset within 24 to 72 hours of exposure. Phototoxicity is a direct response as opposed to a delayed hypersensitivity reaction.³

To test for this, the maximal use trial (MUsT) is conducted as part of the bioavailability and pharmacology assessment that captures the effect of maximal use on absorption into blood. In MUsT, BEMT plasma concentrations resulted in a steady-state blood level below the FDA threshold of 0.5 ng/mL, reducing the need for systemic carcinogenicity, developmental, and reproductive toxicity studies. Unlike BEMT, filters that have already been approved by the FDA, such as avobenzone, oxybenzone, and octocrylene, have plasma concentrations greater than 0.5 ng/mL, indicating more systemic absorption compared to BEMT.³

Pharmacists’ Role

Pharmacists can educate patients on sunscreen benefits and usage, including the significance of broad-spectrum protection against skin cancer. Additionally, patients can receive education about the newly approved sunscreen filter, BEMT, and be informed about sunscreen categories to raise awareness of recent sunscreen advancements. The approval of BEMT highlights the addition of a new UV filter to the US sunscreen market and its potential role in enhancing protection against UV-induced skin damage and diseases.

With the addition of BEMT, the US now has 3 Category I sunscreen filters. BEMT is also the first organic Category I sunscreen filter in the US that provides protection against UVA and UVB radiation with high photostability and minimal systemic absorption. Furthermore, this filter does not have a chalky white texture like the other 2 inorganic Category I filters (ZnO and TiO2), making it more cosmetically pleasing for patients.^1,3,6,7 Lastly, BEMT does not appear to cause endocrine disruptions, which addresses another consumer concern.³

REFERENCES

1. FDA expands sunscreen options for the first time in 20 years. News release. FDA. June 9, 2026. Accessed June 30, 2026. https://www.fda.gov/news-events/press-announcements/fda-expands-sunscreen-options-first-time-20-years

2. Final administrative order (OTC00039) amending over-the-counter monograph M020: sunscreen drug products for over-the-counter human use, and related information. FDA. June 10, 2026. Accessed June 30, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/omuf/order/supportDoc/OTC000039/Final_Administrative_Order.pdf

3. Turner CW, Torgerson L. Modernizing US suncreen regulations: how newer filters can improve public health. Photodermatol Photoimmunol Photomed. 2025;41(5):e70032. doi:10.1111/phpp.70032

4. Cancer stat facts: melanome of the skin. National Cancer Institute Surveillance, Epidemiology, and End Results Program. Accessed June 30, 2026. https://seer.cancer.gov/statfacts/html/melan.html

5. Ultraviolet (UV) radiation. FDA. Updated August 19, 2020. Accessed June 30, 2026. https://www.fda.gov/radiation-emitting-products/tanning/ultraviolet-uv-radiation

6. Mohammed H, Kohli I, Lim HW. From ultraviolet to visible light: emerging concepts in comprehensive photoprotection. Photodermatol Photoimmunol Photomed. 2026;42(3):e70098. doi:10.1111/phpp.70098

7. Ziglar J, Mohammad TF, Gilaberte Y, Lim HW. Sunscreens: updates on sunscreen filters and formulations. Photodermatol Photoimmunol Photomed. 2025;41(3):e70026. doi:10.1111/phpp.70026

8. FDA Center for Drug Evaluation and Research finding of no significant impact bemotrizinol, up to 6%. FDA. June 5, 2026. Accessed June 30, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/omuf/order/supportDoc/OTC000039/FONSI.pdf