Drug Update · Dermatology

FDA Adds Bemotrizinol to OTC Sunscreen Monograph

September 07, 2026

Regulatory action

Final Administrative Order OTC000039 (Issued June 10, 2026; corrected August 10, 2026)

Permitted concentration

up to 6 percent

Minimum SPF for finished product

not less than 2

Approved age group

adults and children 6 months of age and older

Clinical Perspective

Clinicians caring for patients who advise on photoprotection—dermatologists, primary care clinicians, pediatricians, and pharmacists—should be aware that bemotrizinol is now a permitted OTC sunscreen active ingredient under Monograph M020 for use in adults and children 6 months of age and older ^[2]^[3]. The FDA’s final order supports availability of bemotrizinol-containing topical sunscreen formulations at concentrations up to 6 percent, in specific combinations and dosage forms, which may expand product choices for patients seeking broad UVA and UVB protection ^[2]^[3]. sunscreen products in routine practice remains to be determined?

Dr. Divya Agarwal, MBBS, MD (Dermatology, Venereology & Leprosy) · Dermatology

The U.S. Food and Drug Administration added bemotrizinol to Over-the-Counter Monograph M020 for sunscreen drug products via Final Administrative Order OTC000039 issued June 10, 2026 (corrected August 10, 2026), establishing conditions for its use at concentrations up to 6 percent in OTC sunscreens for adults and children 6 months of age and older ^[2]^[3]. The FDA concluded there is adequate evidence from human clinical efficacy and safety data to consider bemotrizinol generally recognized as safe and effective under the monograph process ^[2]^[3].

Clinical Context

Bemotrizinol is an ultraviolet (UV) filter that provides protection against both UVA and UVB radiation, and has been marketed in other countries prior to this action ^[3]. DSM Nutritional Products LLC submitted an Over-the-Counter Monograph Order Request to add bemotrizinol to OTC Monograph M020; FDA reviewed clinical and nonclinical data, independent literature reviews, and submissions received during the rulemaking process before issuing Final Administrative Order OTC000039 ^[2]. FDA determined bemotrizinol can be included in OTC sunscreen products under specific conditions (including concentration limits, permitted combinations, and dosage forms) and that those conditions are necessary to ensure products containing bemotrizinol are GRASE for use by adults and children 6 months and older ^[2]^[3]. The FDA press announcement notes bemotrizinol is the first new active ingredient added to the OTC sunscreen monograph since the late 1990s and that the action aligns with efforts to modernize the monograph process ^[3].

Key Findings

FDA’s Final Administrative Order OTC000039 adds bemotrizinol as a permitted sunscreen active ingredient in OTC Monograph M020 at concentrations up to 6 percent and establishes that finished drug products containing bemotrizinol must provide a minimum sun protection factor (SPF) value of not less than 2 ^[2].
FDA concluded there is adequate evidence from two independent human clinical efficacy studies to support the efficacy of bemotrizinol at concentrations up to 6 percent for use as a sunscreen active ingredient intended for use in adults and children 6 months of age and older, and determined there is adequate evidence of safety at concentrations up to 6 percent based on nonclinical, clinical pharmacology, and clinical safety studies and information ^[2].
The final order specifies permitted combinations and exclusions: a single drug product may combine bemotrizinol with any single sunscreen active ingredient identified in § M020.10 except aminobenzoic acid (PABA) or trolamine salicylate, and may combine with certain skin protectant active ingredients identified in OTC Monograph M016, subject to additional conditions ^[2].
FDA identified permitted dosage forms for bemotrizinol-containing products as oil, lotion, cream, gel, butter, paste, ointment, stick, or spray (with spray-specific conditions) ^[2].
Independent photostability and phototoxicity research has shown bemotrizinol can act as a photostabilizer for certain UV-filter combinations and reduced in vitro phototoxicity in some formulations, with clinical tests in that study not indicating phototoxic or photoallergenic potentials in the formulations tested ^[1].

Safety & Tolerability

Rarely causes skin irritation was reported as an expected adverse effect in FDA summaries and communications reviewing bemotrizinol ^[3]^[4].
Low levels of absorption through the skin into the body were noted in FDA summaries of the data reviewed ^[3].

Study Design

The regulatory action is Final Administrative Order OTC000039, issued by the U.S. Food and Drug Administration on June 10, 2026 (corrected August 10, 2026), amending OTC Monograph M020 to add bemotrizinol as a sunscreen active ingredient with specified conditions for concentration, permitted combinations, and dosage forms ^[2]. The requestor for the monograph order was DSM Nutritional Products LLC, which submitted an OMOR to add bemotrizinol at concentrations up to 6 percent ^[2]. FDA’s determination referenced a scientific review of available data, including two independent human clinical efficacy studies, nonclinical and clinical safety studies, and literature reviews ^[2].

FAQ

Q1 What is bemotrizinol approved for?

Bemotrizinol was added to the OTC Monograph M020 as a permitted sunscreen active ingredient for use in over-the-counter sunscreen drug products. The FDA’s Final Administrative Order allows bemotrizinol-containing products to be marketed without an approved application under section 505 of the FD&C Act when they conform to the monograph conditions, and specifies use in adults and children 6 months of age and older. The action establishes permitted concentrations, combinations, and dosage forms for bemotrizinol.

Q2 How does bemotrizinol work?

Bemotrizinol functions as a UV filter providing protection against both ultraviolet A (UVA) and ultraviolet B (UVB) radiation. FDA review materials and press communications noted that bemotrizinol provides broad-spectrum UV protection and was associated with low levels of systemic absorption in the data reviewed. Independent formulation studies have reported that bemotrizinol can improve photostability of certain UV-filter combinations and reduce in vitro phototoxicity in some formulations.

Q3 What is the allowed concentration or dose for bemotrizinol in OTC products?

The FDA’s Final Administrative Order permits bemotrizinol in OTC sunscreen drug products at concentrations up to 6 percent (interpreted by FDA as up to and including 6 percent) and requires that finished products provide a minimum SPF value of not less than 2. The final order also specifies permitted combinations of bemotrizinol with other sunscreen active ingredients and with certain skin protectant active ingredients, and lists allowable dosage forms. Clinicians should consult current prescribing information for complete dosing guidance.

Q4 What are the side effects of bemotrizinol?

FDA materials indicate bemotrizinol is associated with low levels of absorption through the skin and was described in agency communications as rarely causing skin irritation. FDA’s safety determination for inclusion in the monograph was based on a review of nonclinical, clinical pharmacology, and clinical safety studies and information supporting adequate evidence of safety at concentrations up to 6 percent for adults and children 6 months of age and older. Information on adverse-event frequencies for specific products containing bemotrizinol will depend on product labeling and postmarketing data.

Clinicians should consult current prescribing information for complete dosing guidance.

FDA Adds Bemotrizinol to OTC Sunscreen Monograph

Direct Clinical Takeaway & Evidence Summary

FDA Adds Bemotrizinol to OTC Sunscreen Monograph

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

Cite & Reference This Monograph

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