Ethylhexyl Salicylate
Also known as Octisalate, 2-Ethylhexyl salicylate, Ethylhexyl salicylate
“CIR Expert Panel says: safe as used in cosmetics.”
Ethylhexyl salicylate (octisalate, CAS 118-60-5) is an organic UVB filter widely used in sunscreens. CIR assessed it as safe-qualified (SQ) in IJT 22(3):1-108, requiring formulations to avoid irritation and to include sun-protection directions when increased UV sensitivity is expected. A 2020 FDA-sponsored randomized clinical trial (PMID 31961417) detected measurable systemic absorption of octisalate after whole-body sunscreen application, with plasma concentrations exceeding the 0.5 ng/mL FDA threshold for waiving additional safety studies, triggering requests for further preclinical data. A 2025 mode-of-action analysis (PMID 40208192) concluded that octisalate and five other organic UV filters are not genotoxic and lack biologically relevant carcinogenic mechanisms, supporting continued safe use at approved concentrations. A 2007 fragrance safety review (PMID 18031898) provided a comprehensive toxicologic and dermatologic assessment of ethylhexyl salicylate as a fragrance ingredient. Evidence quality is moderate: systemic absorption is confirmed but margins of safety at typical use concentrations remain under active regulatory review.
Effective UVB absorber (absorption maximum ~310 nm); frequently combined with avobenzone or other UV filters to provide broad-spectrum protection
Low acute toxicity; well-established safety profile over decades of sunscreen use at concentrations up to 5%
Not genotoxic and no carcinogenic mode of action identified in mode-of-action analysis
Good photostability and formulation compatibility; used as a solvent for other UV filters
- · Systemic absorption confirmed in humans at concentrations exceeding the FDA 0.5 ng/mL threshold; FDA has requested additional preclinical safety studies under the Sunscreen Innovation Act
- · CIR SQ qualification requires formulations to avoid irritation and to include daily sun protection directions when increased sun sensitivity is expected
- · EU Regulation (EC) No 1223/2009 Annex VI restricts use to maximum 5% as UV filter; no general use outside UV-filter function is addressed at this concentration
- · Potential photoallergy reactions reported in case literature, though sensitization rate is considered low at approved concentrations
CIR Quick Reference Table (12/2017, revised 07/2018) — Ethylhexyl Salicylate row: Finding=SQ, Citation=IJT 22(3):1-108
“Ethylhexyl Salicylate SQ safe when formulated to avoid irritation and to avoid increasing sun sensitivity, or when increased sun sensitivity would be expected, directions for use include the daily use of sun protection. IJT 22(3):1-108”— QRT-122017revised072018.pdf, p. 50