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Cited by 0Skin Protection and AgingHealthcare RegulationContact Dermatitis and Allergies

Response to Pak et al, “Regulatory gaps in sunscreen approval: A comparison of U.S. and Korean UV filters.” Sunscreen regulatory update: approval of bemotrizinol by the US FDA

Open access
Adler, Brandon L.·2026·Journal of the American Academy of Dermatology
DOI 10.1016/j.jaad.2026.06.105
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AI snapshot

Written from the paper’s full text.

TL;DR

This letter to the editor updates the sunscreen regulatory landscape in the US following Pak et al.'s comparison of US and Korean UV filters, reporting that bemotrizinol (BEMT) became the first new FDA-approved sunscreen active ingredient since 1999. It argues BEMT's broad-spectrum, photostable, minimally absorbed profile makes it a valuable addition, while noting the two-decade, ~$20 million path to approval and the recent SAFE Sunscreen Standards Act's call for real-world evidence.

Key findings

  • In December 2025 the FDA issued a proposed order to add bemotrizinol (bisethylhexyloxyphenol methoxyphenyl triazine, BEMT) to the sunscreen OTC monograph; as of the letter's writing date (June 9, 2026) the action was finalized, making BEMT the first new sunscreen active ingredient approved by the FDA since 1999.
  • BEMT is described as an organic UV filter offering broad-spectrum UVA/UVB protection including long-wave UVA, photostability (unlike avobenzone, "until now our only truly broad-spectrum organic UV filter"), compatibility with all other approved UV filters, and satisfaction of FDA's minimal systemic absorption requirement, making it GRASE.
  • Despite international use since 2000, FDA approval via the OTC monograph process required over 20 years of manufacturer effort, including rigorous pharmacokinetic and safety studies and an estimated $20 million expenditure.
  • In late 2025 the Supporting Accessible, Flexible, and Effective (SAFE) Sunscreen Standards Act was signed into law, directing the FDA to allow real-world evidence, including observational studies, to support sunscreen active ingredient safety and effectiveness.

Methods

  • This is a single-author letter to the editor (correspondence) responding to Pak et al. and providing a regulatory update; no study design, dataset, or sample is reported.
  • No primary data collection or statistical analysis is described; the content is a narrative synthesis of FDA actions, a press announcement, and prior publications (including the author's own CME article and Cutis piece).
  • Not stated in the paper (no formal methods).

Limitations

  • The paper states no limitations.
  • Evident from the text: the letter is a brief, single-author commentary with no primary data, relying on an FDA press announcement and secondary sources; several cited references are the author's own prior work, and the approval timeline and cost figures are attributed to those secondary sources rather than independently verified.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1016/j.jaad.2026.06.105

Cites

4 of 5 references verified0 citation errors · 1 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 20 cited sources checked · 0 supported · 0 flagged

  • Premisecitation

    BEMT's approval required rigorous pharmacokinetic and safety studies.

    “including rigorous pharmacokinetic and safety studies”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [5] Adler, 2026, Sunscreen in 2026: doping, regulatory changes, and impact on vitamin D levels, Cutis source
  • Premisecitation

    BEMT is photostable.

    “it is photostable (unlike avobenzone, until now our only truly broad-spectrum organic UV filter)”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [3] D'Ruiz, 2023, Preliminary clinical pharmacokinetic evaluation of bemotrizinol - A new sunscreen active ingredient being considered for inclusion under FDA's over-the-counter (OTC) sunscreen monograph, Regul Toxicol Pharmacol source
    • cites [4] Wang, 2026, Pending Food and Drug Administration approval of bemotrizinol: a potential turning point for United States sunscreen formulation, J Am Acad Dermatol source
  • Interpretationreasoning

    BEMT is generally recognized as safe and effective (GRASE).

    “thus being generally recognized as safe and effective (GRASE).3,4”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [3] D'Ruiz, 2023, Preliminary clinical pharmacokinetic evaluation of bemotrizinol - A new sunscreen active ingredient being considered for inclusion under FDA's over-the-counter (OTC) sunscreen monograph, Regul Toxicol Pharmacol source
    • cites [4] Wang, 2026, Pending Food and Drug Administration approval of bemotrizinol: a potential turning point for United States sunscreen formulation, J Am Acad Dermatol source
  • Premisecitation

    In late 2025, the Supporting Accessible, Flexible, and Effective (SAFE) Sunscreen Standards Act was signed into law.

    “In late 2025, the Supporting Accessible, Flexible, and Effective (SAFE) Sunscreen Standards Act was signed into law”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [5] Adler, 2026, Sunscreen in 2026: doping, regulatory changes, and impact on vitamin D levels, Cutis source
  • Premisecitation

    BEMT can be combined with all other approved UV filters to produce cosmetically appealing formulations.

    “can be combined with all other approved UV filters to produce cosmetically appealing formulations”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [3] D'Ruiz, 2023, Preliminary clinical pharmacokinetic evaluation of bemotrizinol - A new sunscreen active ingredient being considered for inclusion under FDA's over-the-counter (OTC) sunscreen monograph, Regul Toxicol Pharmacol source
    • cites [4] Wang, 2026, Pending Food and Drug Administration approval of bemotrizinol: a potential turning point for United States sunscreen formulation, J Am Acad Dermatol source
  • Classified as probably not a substantial claim. 2
  • May combine two claims. 1

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    BEMT's approval required an estimated $20 million expenditure.

    “and an estimated $20 million expenditure.5”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [5] Adler, 2026, Sunscreen in 2026: doping, regulatory changes, and impact on vitamin D levels, Cutis source

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Interpretationreasoning

    The SAFE Act's call for real-world evidence is particularly relevant for ingredients such as BEMT that have been available outside the US for many years without safety concerns.

    “This is particularly relevant for ingredients such as BEMT that have been available outside the US for many years without safety concerns.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: BEMT has been available outside the US for many years without safety concerns.

  • May combine two claims.

    Premisecitation

    On June 9, 2026, the FDA finalized the action, making BEMT the first new sunscreen active ingredient approved by the FDA since 1999.

    “On the day of this writing (June 9, 2026), the action was finalized, making BEMT the first new sunscreen active ingredient approved by the FDA since 1999. 2”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [2]

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

3 of 3

  • The paper relies on this without support.

    BEMT has been available outside the US for many years without safety concerns.

    “ingredients such as BEMT that have been available outside the US for many years without safety concerns.”
1 of 1

Cites

Flagged first, then by citations

1 of the 4 references couldn’t be matched to a known paper.

Cited by

Still being checked.

Related

Authors
Adler, B. L.
Affiliations
University of Southern California (US)
Corresponding author
Adler, Brandon L.
ORCID
Adler, Brandon L.
Venue
Journal of the American Academy of Dermatology
Publisher
Elsevier BV
Published
2026-11
Volume
95
Issue
5
Pages
e449
ISSN
0190-9622 (ISSN-L)
DOI
10.1016/j.jaad.2026.06.105
OpenAlex
W7166106197
Semantic Scholar
7ace2fef18b5faf3d08d35bc446c0627f8aa8a40
Cited by
0
References
4
FWCI
0.00
Type
journal article
Language
en
Open access
Licence
Locations
  • Journal of the American Academy of Dermatology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Dermatology › Skin Protection and Aging
  • Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
  • Health Sciences › Medicine › Dermatology › Contact Dermatitis and Allergies
Keywords
sunscreen regulation, UV filters, FDA, legislative gaps, photoprotection

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-31.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-31.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

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