WL-AAB-Z-W-988 by Nanophase Technologies Corporation / Amcol Health & Beauty Solutions WL-AAB-Z-W-988

WL-AAB-Z-W-988 by

Drug Labeling and Warnings

WL-AAB-Z-W-988 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-AAB-Z-W-988- zinc oxide lotion 
Nanophase Technologies Corporation

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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WL-AAB-Z-W-988

WL-AAB-Z-W-988 GHS Label

WL-AAB-Z-W-988 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63931-4440
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	135.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MYRISTYL TRISILOXANE (UNII: J7960S4R1T)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)
ALLANTOIN (UNII: 344S277G0Z)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ISODODECANE (UNII: A8289P68Y2)
NIACINAMIDE (UNII: 25X51I8RD4)
WATER (UNII: 059QF0KO0R)
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
PROPANEDIOL (UNII: 5965N8W85T)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)
ISOCETETH-10 (UNII: 1K92T9919H)
CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)
MICA (UNII: V8A1AW0880)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
ZEIN (UNII: 80N308T1NN)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63931-4440-1	150000 mL in 1 DRUM; Type 0: Not a Combination Product	05/06/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/06/2021

Labeler - Nanophase Technologies Corporation (623502044)

Registrant - Nanophase Technologies Corporation (623502044)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		050383046	api manufacture(63931-4440)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		623502044	api manufacture(63931-4440) , manufacture(63931-4440) , pack(63931-4440)

Establishment
Name	Address	ID/FEI	Business Operations
Amcol Health & Beauty Solutions		872684803	api manufacture(63931-4440)

Revised: 9/2021

Document Id: cba85b44-faff-9103-e053-2995a90a3b41

34390-5

Set id: cba85ade-ebe9-0d00-e053-2a95a90a26b1

Version: 1

Effective Time: 20210910