WL-AAE-ZT-O-413: Package Insert and Label Information

WL-AAE-ZT-O-413- titanium dioxide and zinc oxide lotion
Nanophase Technologies Corporation

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WL-AAA-ZT-O-413

GHS label (Bulk)
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WL-AAE-ZT-O-413
titanium dioxide, zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63931-4462
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 19.4 mg in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 9.7 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
OCTYLDODECYL NEOPENTANOATE
PHENOXYETHANOL
POLYESTER-7
TRICETEARETH-4 PHOSPHATE
ETHYLHEXYL ISONONANOATE
HEXYLENE GLYCOL
LECITHIN, SOYBEAN
ALKYL (C12-15) BENZOATE
CAPRYLYL GLYCOL
CETYL ALCOHOL
ETHYLHEXYLGLYCERIN
GLYCERIN
NEOPENTYL GLYCOL DIHEPTANOATE
SILICON DIOXIDE
WATER
XANTHAN GUM
POTASSIUM SORBATE
ALLANTOIN
AVENA SATIVA FLOWERING TOP
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW)
.ALPHA.-BISABOLOL, (+)-
TRILAURETH-4 PHOSPHATE
BUTYLOCTYL SALICYLATE
CETETH-20
PEG-75 STEARATE
PULLULAN
SODIUM CITRATE
SQUALANE
STEARETH-20
Product Characteristics
Color brown Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63931-4462-1 150000 mL in 1 DRUM None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 05/27/2021
Labeler — Nanophase Technologies Corporation (623502044)
Registrant — Nanophase Technologies Corporation (623502044)

Revised: 09/2021 Nanophase Technologies Corporation

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