WL-AAE-Z-O-1039 by Nanophase Technologies Corporation WL-AAE-Z-O-1039

WL-AAE-Z-O-1039 by

Drug Labeling and Warnings

WL-AAE-Z-O-1039 by is a Otc medication manufactured, distributed, or labeled by Nanophase Technologies Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WL-AAE-Z-O-1039- 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-AAE-Z-O-1039

WL-AAE-Z-O-1039

WL-AAE-Z-O-1039 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63931-4465
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	132 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENYLPROPANOL (UNII: 0F897O3O4M)
XANTHAN GUM (UNII: TTV12P4NEE)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
TOCOPHEROL (UNII: R0ZB2556P8)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CETETH-20 (UNII: I835H2IHHX)
PULLULAN (UNII: 8ZQ0AYU1TT)
SQUALANE (UNII: GW89575KF9)
STEARETH-20 (UNII: L0Q8IK9E08)
CYCLODEXTRINS (UNII: 7E6SK9QDT8)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63931-4465-1	150000 mL in 1 DRUM; Type 0: Not a Combination Product	10/04/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/04/2021

Labeler - Nanophase Technologies Corporation (623502044)

Registrant - Nanophase Technologies Corporation (623502044)

Revised: 5/2022

Document Id: deecf27a-a2db-d9a8-e053-2a95a90a9926

34390-5

Set id: deecf3f9-8f32-ec4a-e053-2995a90a336a

Version: 1

Effective Time: 20220513