WL-AAA-Z-A-525- zinc oxide lotion

WL-AAA-Z-A-525 by

Drug Labeling and Warnings

WL-AAA-Z-A-525 by is a Otc medication manufactured, distributed, or labeled by Nanophase Technologies Corporation, Amcol Health & Beauty Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WL-AAA-Z-A-525

INGREDIENTS AND APPEARANCE

WL-AAA-Z-A-525 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63931-4315
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	129.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISODECYL SALICYLATE (UNII: S7097PFP4C)
TOCOPHEROL (UNII: R0ZB2556P8)
PHYSALIS ANGULATA (UNII: W4TKW9D5GG)
ISOCETETH-10 (UNII: 1K92T9919H)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ISODODECANE (UNII: A8289P68Y2)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
ALLANTOIN (UNII: 344S277G0Z)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63931-4315-1	150000 mL in 1 DRUM; Type 0: Not a Combination Product	03/26/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/26/2019

Labeler - Nanophase Technologies Corporation (623502044)

Registrant - Nanophase Technologies Corporation (623502044)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		050383046	api manufacture(63931-4315)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		623502044	api manufacture(63931-4315) , manufacture(63931-4315) , pack(63931-4315)

Establishment
Name	Address	ID/FEI	Business Operations
Amcol Health & Beauty Solutions		872684803	api manufacture(63931-4315)