Zinc oxide
Zinc oxide is an inorganic white powder, ZnO. Most is made by the French (indirect) process, which vaporizes zinc metal and burns it in air, or by wet chemical precipitation followed by calcining. Personal care brands buy it as a pigment-grade powder, as fine or nano-sized particles for sunscreens, often surface-coated, or as a ready-made dispersion in an emollient. It is used as an OTC sunscreen and skin protectant active, a cosmetic color and a food nutrient.
Suppliers sell different products under the same name. Specify the one you need.
Conventional zinc oxide made to the USP monograph, used in skin protectant ointments and as a white pigment.
Fine particles sized for transparency in sunscreens; the particle size distribution should be on the specification.
Particles treated with silica, dimethicone, triethoxycaprylylsilane or similar to help dispersion and limit reactivity.
Zinc oxide pre-dispersed at a stated percentage in an ester, oil or water, which saves milling.
Zinc oxide made to food-chemical specifications for supplements and fortified foods.
Compare each result with your own specification when the lot arrives.
Keep zinc oxide in sealed bags or drums in a dry place, since it picks up moisture and carbon dioxide from air. Fine and nano powders are dusty, so handle with dust controls. Dispersions should be stirred before use if they settle. Shelf life and retest dates come from the supplier.
Particle size, coating and surface area differ between lots and between suppliers and change SPF, feel and whiteness, so record them with each lot. Requalify a new grade or supplier with finished-product testing rather than swapping it in.
Facts from regulators and standards bodies, each linked to its source.
21 CFR 352.10 lists zinc oxide up to 25 percent among OTC sunscreen active ingredients, and in its 2021 proposed order FDA proposed GRASE status for sunscreens containing zinc oxide and/or titanium dioxide.
Source: ecfr.gov (opens in a new tab)21 CFR 347.10 lists zinc oxide, 1 to 25 percent, as an OTC skin protectant active ingredient.
Source: ecfr.gov (opens in a new tab)21 CFR 73.2991 permits zinc oxide as a color additive in cosmetics, including products for the eye area, and exempts it from batch certification.
Source: ecfr.gov (opens in a new tab)Health Canada's Primary Sunscreen Monograph lists zinc oxide (C.I. No. 77947) as a UVA and UVB filter at up to 25%.
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.
Distributor · Redmond, WA
US supplier of cosmetic ingredients repackaged in retail and bulk sizes, covering actives, butters, oils, waxes and emulsifiers for brands, contract manufacturers and independent formulators.
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 pigment-grade powder, micronized and nano grades, coated zinc oxide, dispersions and food and nutrient grade. Ask each supplier for the specification sheet of the exact grade they quote.
Expect assay (titration), lead, cadmium, arsenic and mercury, particle size and surface area, coating content and microbiology, each with its method, specification and result for that lot.
Keep zinc oxide in sealed bags or drums in a dry place, since it picks up moisture and carbon dioxide from air. Fine and nano powders are dusty, so handle with dust controls. Dispersions should be stirred before use if they settle. Shelf life and retest dates come from the supplier.
21 CFR 352.10 lists zinc oxide up to 25 percent among OTC sunscreen active ingredients, and in its 2021 proposed order FDA proposed GRASE status for sunscreens containing zinc oxide and/or titanium dioxide. 21 CFR 347.10 lists zinc oxide, 1 to 25 percent, as an OTC skin protectant active ingredient. 21 CFR 73.2991 permits zinc oxide as a color additive in cosmetics, including products for the eye area, and exempts it from batch certification. Health Canada's Primary Sunscreen Monograph lists zinc oxide (C.I. No. 77947) as a UVA and UVB filter at up to 25%.
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