WL-AAE-ZT-O-1337 by Nanophase Technologies Corporation WL-AAE-ZT-O-1337

WL-AAE-ZT-O-1337 by

Drug Labeling and Warnings

WL-AAE-ZT-O-1337 by is a Otc medication manufactured, distributed, or labeled by Nanophase Technologies Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WL-AAE-ZT-O-1337- titanium dioxide, 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-ZT-O-1337

WL-AAE-ZT-O-1337

WL-AAE-ZT-O-1337 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63931-4518
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	19.4 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9.7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
DICRATERIA ROTUNDA OIL (UNII: Z0DWU9R4GM)
RUTTNERA LAMELLOSA OIL (UNII: 5XZ38R4SUT)
SODIUM ASCORBATE (UNII: S033EH8359)
TOCOPHEROL (UNII: R0ZB2556P8)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYESTER-7 (UNII: 0841698D2F)
TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO)
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ALLANTOIN (UNII: 344S277G0Z)
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F)
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CETETH-20 (UNII: I835H2IHHX)
PEG-75 STEARATE (UNII: OT38R0N74H)
PULLULAN (UNII: 8ZQ0AYU1TT)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SQUALANE (UNII: GW89575KF9)
STEARETH-20 (UNII: L0Q8IK9E08)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63931-4518-1	150000 mL in 1 DRUM; Type 0: Not a Combination Product	02/23/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/23/2022

Labeler - Nanophase Technologies Corporation (623502044)

Registrant - Nanophase Technologies Corporation (623502044)

Revised: 2/2022

Document Id: d8afb8b5-8a76-07c8-e053-2a95a90a51b4

34390-5

Set id: d8afae0d-920b-e4e8-e053-2995a90ad817

Version: 1

Effective Time: 20220223