ODACITE- zinc oxide lotion

ODACITE by

Drug Labeling and Warnings

ODACITE by is a Otc medication manufactured, distributed, or labeled by Odacite Skincare. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Odacite

INGREDIENTS AND APPEARANCE

ODACITE 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82088-131
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	132 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
JOJOBA OIL (UNII: 724GKU717M)
GLYCERIN (UNII: PDC6A3C0OX)
ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
COCO-CAPRYLATE (UNII: 4828G836N6)
NYLON-12 (UNII: 446U8J075B)
PHENYLPROPANOL (UNII: 0F897O3O4M)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
METHYLHEPTYL ISOSTEARATE (UNII: 981F40Q9FF)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
ALLANTOIN (UNII: 344S277G0Z)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
PROPANEDIOL (UNII: 5965N8W85T)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
CHAMOMILE (UNII: FGL3685T2X)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82088-131-02	1 in 1 CARTON	04/18/2022
1	NDC: 82088-131-01	30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/18/2022

Labeler - Odacite Skincare (079682742)