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Ingredient dossier · No. 012

Homosalate

Also: homomenthyl salicylate · HMS · 3,3,5-trimethylcyclohexyl salicylate


AvoidEU restricted concentration in 2021 citing endocrine concerns; FDA categorized as not GRASE pending more safety data.


01 · Hormonal impact

Testosterone & hormonal load

Evidence
ModerateAnimal studies with mechanistic evidence

The EU SCCS reduced the allowable concentration of homosalate in sunscreens from 10% to 1.4% in its 2021 opinion, citing endocrine disruption potential. Homosalate shows estrogenic activity in cell studies and anti-androgenic activity in androgen receptor reporter assays. FDA's 2021 sunscreen monograph update classified it as 'not GRASE' pending additional toxicology data.


02 · Where it appears

Found in.

01Chemical sunscreen
02SPF moisturizers
03After-sun lotion
04SPF lip balm

03 · The regulators

Two jurisdictions, two different verdicts.

European Union

SCCS/1622/20 (2021) recommended reduction from 10% to 1.4% maximum; endocrine disruption flagged as the primary concern.

United States · FDA

Classified as 'not GRASE' in the 2021 proposed sunscreen monograph update, requiring additional safety data.


04 · Sources

The receipts.

  1. [01]
    SCCS/1622/20 — Opinion on Homosalate (EU, 2021)
    ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_250.pdf
  2. [02]
    FDA — OTC sunscreen proposed order Q&A
    www.fda.gov/drugs/understanding-over-counter-medicines/questions-and-answers-fda-posts-deemed-final-order-and-proposed-order-over-counter-sunscreen
  3. [03]

05 · Related dossiers
01Oxybenzone (Benzophenone-3)D · 1502Octinoxate (Ethylhexyl Methoxycinnamate)D · 2503OctocryleneD · 28
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