Octinoxate
Octinoxate is a cinnamate UV filter that absorbs mainly UVB. It is made by esterifying 4-methoxycinnamic acid with 2-ethylhexanol, or by related condensation routes, and then distilled. It is a pale yellow, oil-soluble liquid used in the oil phase of sunscreens and of cosmetics that carry a UV filter. In the U.S. it is an OTC sunscreen drug active, listed in older regulations as octyl methoxycinnamate.
Suppliers sell different products under the same name. Specify the one you need.
Octinoxate made to the USP monograph for OTC sunscreen use.
Ethylhexyl methoxycinnamate sold as a cosmetic UV filter in other markets; check documentation before U.S. drug use.
Octinoxate in silica or polymer capsules, supplied as a dispersion with a stated active level.
Compare each result with your own specification when the lot arrives.
Store octinoxate in closed, full, light-resistant containers at room temperature. Light changes its isomer ratio, so keep drums out of sunlight and reseal them promptly. Shelf life and retest date come from the supplier.
Record assay and isomer content for each lot. Keep certificates for drug GMP records and use lots in order of receipt.
Facts from regulators and standards bodies, each linked to its source.
21 CFR 352.10 lists octyl methoxycinnamate (octinoxate) up to 7.5 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 octinoxate 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 octinoxate (octyl methoxycinnamate) as a UVB filter at up to 7.5%.
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.
Manufacturers and distributors whose own websites say they sell it.
Manufacturer · Navi Mumbai, India
Indian producer of surfactants and specialty care ingredients, including sulfates, mild amino-acid and glucoside surfactants, emollient esters and UV filters for personal and home care.
Suppliers are in alphabetical order and none pays to appear. Each claim is checked against the supplier’s own website on the date shown. Ask for the specification sheet and a recent COA before you order, and confirm details with the supplier.
Common forms include uSP / drug-grade liquid, cosmetic-grade liquid and encapsulated octinoxate. Ask each supplier for the specification sheet of the exact grade they quote.
Expect assay (GC or HPLC), e/Z isomer content, specific absorbance, acid value and color and refractive index and specific gravity, each with its method, specification and result for that lot.
Store octinoxate in closed, full, light-resistant containers at room temperature. Light changes its isomer ratio, so keep drums out of sunlight and reseal them promptly. Shelf life and retest date come from the supplier.
21 CFR 352.10 lists octyl methoxycinnamate (octinoxate) up to 7.5 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 octinoxate 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 octinoxate (octyl methoxycinnamate) as a UVB filter at up to 7.5%.
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