WL-AAS-Z-A-348- zinc oxide lotion

WL-AAS-Z-A-348 by

Drug Labeling and Warnings

WL-AAS-Z-A-348 by is a Otc medication manufactured, distributed, or labeled by Nanophase Technologies Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WL-AAS-Z-A-348

INGREDIENTS AND APPEARANCE

WL-AAS-Z-A-348 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63931-4302
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	95 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PROPANEDIOL (UNII: 5965N8W85T)
PHENYLPROPANOL (UNII: 0F897O3O4M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)
TOCOPHEROL (UNII: R0ZB2556P8)
ISODODECANE (UNII: A8289P68Y2)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SQUALANE (UNII: GW89575KF9)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63931-4302-1	7000 mL in 1 PAIL; Type 0: Not a Combination Product	07/24/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/24/2019

Labeler - Nanophase Technologies Corporation (623502044)

Registrant - Nanophase Technologies Corporation (623502044)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		050383046	api manufacture(63931-4302)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		623502044	api manufacture(63931-4302) , manufacture(63931-4302) , pack(63931-4302)

Establishment
Name	Address	ID/FEI	Business Operations
Amcol Health & Beauty Solutions		872684803	api manufacture(63931-4302)