{"product_id":"colloidal-oatmeal","title":"Colloidal Oatmeal NF","description":"\u003cp\u003e\u003cstrong\u003eColloidal is a particle-size specification, not a marketing word. Forty-four microns is what the monograph requires and it is what we ship.\u003c\/strong\u003e\u003c\/p\u003e\u003cdiv class=\"bf-alert\"\u003e\u003cp\u003e\u003cstrong\u003eOTC monograph status.\u003c\/strong\u003e Colloidal oatmeal is a Category I OTC skin protectant under FDA OTC Monograph M016, minimum concentration 0.007%. If you make skin-protectant drug claims — 'protects and helps relieve minor skin irritation', 'temporarily protects' — your product becomes an OTC drug requiring a Drug Facts panel, an NDC and facility registration. Cosmetic claims like soothing and softening keep it a cosmetic. This is a claims-architecture decision that needs to reach whoever writes your copy, not just your formulator.\u003c\/p\u003e\u003c\/div\u003e\u003ch3\u003eIdentity\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eINCI name:\u003c\/strong\u003e Avena Sativa (Oat) Kernel Flour\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCAS number:\u003c\/strong\u003e 134134-86-4\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eEC \/ EINECS:\u003c\/strong\u003e Not confirmed.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePhysical form:\u003c\/strong\u003e Powder\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCountry of origin:\u003c\/strong\u003e USA\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eHS tariff code:\u003c\/strong\u003e 1104.12 \/ 1104.22\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eGrade:\u003c\/strong\u003e USP \/ NF\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eShelf life:\u003c\/strong\u003e 24 months\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cem\u003eCAS note: 84012-26-0 is Avena Sativa Kernel Extract — a different material. Do not substitute one for the other on a label.\u003c\/em\u003e\u003c\/p\u003e\u003ch3\u003eSpecification\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eAppearance:\u003c\/strong\u003e Fine light tan powder\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eOdour:\u003c\/strong\u003e Faint cereal\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eComposition:\u003c\/strong\u003e Particle size 44 micrometers. USP\/NF grade.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSolubility:\u003c\/strong\u003e Disperses in water to form a colloidal suspension. Dispersible is the technically accurate term — several suppliers say 'soluble', which it is not.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eMelting point:\u003c\/strong\u003e n\/a\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003epH:\u003c\/strong\u003e Verify against lot COA\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eHLB:\u003c\/strong\u003e n\/a\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eStorage:\u003c\/strong\u003e Cool, dry, sealed\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eManufacturing process:\u003c\/strong\u003e Oat grains cleaned, de-hulled, size-reduced, steam heat-treated, flattened and pulverized to 44 µm.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eRecommended use rates\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eBath treatment:\u003c\/strong\u003e 20–30%\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eLotion and cream:\u003c\/strong\u003e 1–5%\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCleanser:\u003c\/strong\u003e 3–10%\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eMask:\u003c\/strong\u003e 5–20%\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eGeneral:\u003c\/strong\u003e 5–30%\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eFormulation notes\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e44 microns is the spec that makes it colloidal and it is the basis of the OTC monograph. Ground oat flour at 200 microns is a different material with a different regulatory status.\u003c\/li\u003e\n\u003cli\u003eDisperse into water with shear before adding to your batch. Dry-adding it to an emulsion gives you lumps that never recover.\u003c\/li\u003e\n\u003cli\u003eThe gluten question is not optional. Get the certificate.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eApplications\u003c\/h3\u003e\u003cp\u003eBath soak · Lotion and cream · Facial cleanser and mask · Baby products · Soap · After-sun\u003c\/p\u003e\u003ch3\u003eSafety and GHS\u003c\/h3\u003e\u003cp\u003eNot classified as hazardous under 29 CFR 1910.1200 (HazCom 2012, as amended 2024). Determination to be confirmed against the incoming lot's manufacturer SDS before publication.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eTransport:\u003c\/strong\u003e Not regulated for transport — DOT, IATA, IMDG.\u003c\/p\u003e\u003ch3\u003eCompliance\u003c\/h3\u003e\u003cp\u003e\u003cstrong\u003eCalifornia Proposition 65:\u003c\/strong\u003e No listed constituent identified.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eAllergen and sourcing:\u003c\/strong\u003e Oats are inherently gluten-free but are very commonly cross-contaminated with wheat, barley and rye in the field and at the mill. This is the single most common labeling error with oat-derived cosmetics. We certify and test every lot to \u0026lt;20 ppm and supply the certificate. Do not make a gluten-free claim on oat material without one.\u003c\/p\u003e\u003cp\u003e\u003cem\u003eSupplied for use as an ingredient in cosmetic formulations. Not for consumer use as supplied. Not for food, drug or medical device use.\u003c\/em\u003e\u003c\/p\u003e","brand":"IHL","offers":[{"title":"1 lb","offer_id":51202192113911,"sku":"BF-OAT-01","price":10.95,"currency_code":"USD","in_stock":false},{"title":"5 lb","offer_id":51202192146679,"sku":"BF-OAT-05","price":44.35,"currency_code":"USD","in_stock":false},{"title":"25 lb","offer_id":51202192179447,"sku":"BF-OAT-25","price":218.25,"currency_code":"USD","in_stock":false},{"title":"80 lb drum","offer_id":51202192212215,"sku":"BF-OAT-80","price":501.0,"currency_code":"USD","in_stock":false},{"title":"640 lb pallet","offer_id":51202192244983,"sku":"BF-OAT-PAL","price":3880.0,"currency_code":"USD","in_stock":false}],"url":"https:\/\/inventoryhandling.com\/products\/colloidal-oatmeal","provider":"Inventory Handling \u0026 Logistics","version":"1.0","type":"link"}