WL-AAE-Z-O-1039

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
zinc oxide lotion

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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - Nanophase Technologies Corporation (623502044)

Registrant - Nanophase Technologies Corporation (623502044)