Ultraceuticals Ultra UV Protective Daily Moisturising

ULTRACEUTICALS ULTRA UV PROTECTIVE DAILY MOISTURISING- zinc oxide lotion
Ultraceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ULTRACEUTICALS ULTRA UV PROTECTIVE DAILY MOISTURISING
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10028-158
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	154 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALLANTOIN, (+)- (UNII: XDK458E1J9)
PHENYLPROPANOL (UNII: 0F897O3O4M)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ISODODECANE (UNII: A8289P68Y2)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
.BETA.-TOCOPHEROL (UNII: 9U6A490501)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAFFEINE (UNII: 3G6A5W338E)
CARNOSINE (UNII: 8HO6PVN24W)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
ISOAMYL LAURATE (UNII: M1SLX00M3M)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10028-158-06	1 in 1 CARTON	05/22/2023
1	NDC:10028-158-05	75 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	05/22/2023

Labeler - Ultraceuticals (744068995)