ODACITE COLOR BALM - FROSTED PETAL- zinc oxide lotion

Drug Labeling and Warnings

Drug Details [pdf]

Odacite Color Balm - Frosted Petal

Odacite Color Balm - Frosted Petal

Odacite Color Balm - Frosted Petal

Odacite Color Balm - Frosted Petal

Odacite Color Balm - Frosted Petal

Odacite Color Balm - Frosted Petal

Odacite Color Balm - Frosted Petal

Odacite Color Balm - Frosted Petal

INGREDIENTS AND APPEARANCE

ODACITE COLOR BALM - FROSTED PETAL 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82088-501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	220 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
CITRIC ACID (UNII: 2968PHW8QP)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
ISOHEXADECANE (UNII: 918X1OUF1E)
TIN OXIDE (UNII: KM7N50LOS6)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
C13-15 ALKANE (UNII: 114P5I43UJ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CALCIUM SODIUM BOROSILICATE (UNII: 4MM76N4WMY)
ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)
PROPANEDIOL (UNII: 5965N8W85T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
PHENYLPROPANOL (UNII: 0F897O3O4M)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82088-501-02	1 in 1 CARTON	02/15/2025
1	NDC: 82088-501-01	5 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/15/2025

Labeler - Odacite (079682742)