WL-AAB-Z-W-1513- zinc oxide lotion

WL-AAB-Z-W-1513 by

Drug Labeling and Warnings

WL-AAB-Z-W-1513 by is a Otc medication manufactured, distributed, or labeled by Nanophase Technologies Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WL-AAB-Z-W-1513

INGREDIENTS AND APPEARANCE

WL-AAB-Z-W-1513 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63931-1513
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	73.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PHENYLPROPANOL (UNII: 0F897O3O4M)
SODIUM SULFATE (UNII: 0YPR65R21J)
LAURYL PEG-8 DIMETHICONE (300 CPS) (UNII: ELL2U7K8T8)
ISOHEXADECANE (UNII: 918X1OUF1E)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
ALLANTOIN (UNII: 344S277G0Z)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63931-1513-1	150000 mL in 1 DRUM; Type 0: Not a Combination Product	06/23/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/23/2023

Labeler - Nanophase Technologies Corporation (623502044)

Registrant - Nanophase Technologies Corporation (623502044)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		050383046	api manufacture(63931-1513)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		623502044	api manufacture(63931-1513) , manufacture(63931-1513)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		118812921	pack(63931-1513) , manufacture(63931-1513)