Octisalate
Octisalate suppliers and sourcing guide
Octisalate is a salicylate UV filter that absorbs UVB. It is made by esterifying salicylic acid with 2-ethylhexanol and then distilling the ester. It is a colorless to pale yellow oil used in the oil phase of sunscreens, where it also helps dissolve crystalline filters. In the U.S. it is an OTC sunscreen drug active, listed in older regulations as octyl salicylate.
- Category
- Cosmetic actives
- Also known as
- ethylhexyl salicylate (INCI) · octyl salicylate · 2-ethylhexyl salicylate · CAS 118-60-5
- Facts checked
- November 2026
Forms and grades of octisalate
Suppliers sell different products under the same name. Specify the one you need.
USP / drug-grade liquid
Octisalate made to the USP monograph for OTC sunscreen use.
Cosmetic-grade liquid
Ethylhexyl salicylate sold as a cosmetic UV filter or fragrance ingredient in other markets.
Filter blends
Octisalate supplied pre-blended with homosalate, octocrylene or avobenzone.
What to check on the COA
Compare each result with your own specification when the lot arrives.
- Assay (GC)
- Octisalate content against the USP or supplier specification.
- Free salicylic acid and acid value
- Residual acid from manufacture or hydrolysis.
- Refractive index and specific gravity
- Identity checks for the liquid.
- Color and odor
- APHA color and odor against the standard.
- Heavy metals
- Lead and other metals by ICP-MS where the specification requires it.
Storage, lots and expiry
Storage and shelf life
Store octisalate in closed containers at room temperature, away from light and moisture. Reseal opened drums. Shelf life and retest date come from the supplier.
Lots and expiry dates
Record assay and acid value for each lot and keep certificates with drug GMP records. Use lots in order of receipt.
Regulatory status
Facts from regulators and standards bodies, each linked to its source.
21 CFR 352.10 lists octyl salicylate (octisalate) up to 5 percent among OTC sunscreen active ingredients; FDA describes this 1999 final sunscreen monograph as stayed (not in effect).
Source: ecfr.gov (opens in a new tab)FDA says the CARES Act deemed final order for OTC sunscreens (OTC000006) considers sunscreens containing the 16 active ingredients of that 1999 monograph as generally recognized as safe and effective (GRASE).
Source: fda.gov (opens in a new tab)FDA's 2021 proposed order (OTC000008) proposed that sunscreens containing octisalate are not GRASE because additional data are needed; FDA says this is not a conclusion that the ingredient is unsafe and that the remaining proposals will be addressed in future orders.
Source: fda.gov (opens in a new tab)Health Canada's Primary Sunscreen Monograph lists octisalate (2-ethylhexyl salicylate) as a UVB filter at up to 5%.
Source: webprod.hc-sc.gc.ca (opens in a new tab)
This is general information, not regulatory advice. Status differs by country and by how the ingredient is used, so check the rules for your product and market.
Octisalate suppliers
Manufacturers and distributors whose own websites say they sell it.
We are checking octisalate suppliers now
Every listing is checked against the supplier’s own website before it goes live, so this list fills in over the coming weeks. The specs and COA checklist above are ready today.
Sell octisalate? Request a listingFrequently asked questions
What forms of octisalate can brands buy?
Common forms include uSP / drug-grade liquid, cosmetic-grade liquid and filter blends. Ask each supplier for the specification sheet of the exact grade they quote.
What should the COA for octisalate include?
Expect assay (GC), free salicylic acid and acid value, refractive index and specific gravity, color and odor and heavy metals, each with its method, specification and result for that lot.
How should octisalate be stored?
Store octisalate in closed containers at room temperature, away from light and moisture. Reseal opened drums. Shelf life and retest date come from the supplier.
What is the regulatory status of octisalate?
21 CFR 352.10 lists octyl salicylate (octisalate) up to 5 percent among OTC sunscreen active ingredients; FDA describes this 1999 final sunscreen monograph as stayed (not in effect). FDA says the CARES Act deemed final order for OTC sunscreens (OTC000006) considers sunscreens containing the 16 active ingredients of that 1999 monograph as generally recognized as safe and effective (GRASE). FDA's 2021 proposed order (OTC000008) proposed that sunscreens containing octisalate are not GRASE because additional data are needed; FDA says this is not a conclusion that the ingredient is unsafe and that the remaining proposals will be addressed in future orders. Health Canada's Primary Sunscreen Monograph lists octisalate (2-ethylhexyl salicylate) as a UVB filter at up to 5%.
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