WL-AAB-Z-W-982: Package Insert and Label Information

WL-AAB-Z-W-982- zinc oxide lotion
Nanophase Technologies Corporation

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WL-AAB-Z-W-982 GHS Label

GHS label (Bulk)
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WL-AAB-Z-W-982
zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63931-4443
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 135.6 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ISOHEXADECANE
PROPYLENE CARBONATE
PHENYLPROPANOL
METHYLPROPANEDIOL
CAPRYLYL GLYCOL
HYDROLYZED JOJOBA ESTERS (ACID FORM)
TOCOPHEROL
TRIDECYL SALICYLATE
DIMETHYLMETHOXY CHROMANOL
ALLANTOIN
.ALPHA.-BISABOLOL, (+)-
SILICON DIOXIDE
TRILAURETH-4 PHOSPHATE
ISODODECANE
SODIUM HYDROXIDE
WATER
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW)
SODIUM CHLORIDE
TREMELLA FUCIFORMIS FRUITING BODY
MALTODEXTRIN
ALKYL (C12-15) BENZOATE
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES
ISOCETETH-10
DISTEARDIMONIUM HECTORITE
POLYMETHYLSILSESQUIOXANE (11 MICRONS)
PHYSALIS ANGULATA
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
LECITHIN, SOYBEAN
TETRASODIUM GLUTAMATE DIACETATE
GLYCERIN
MICA
TITANIUM DIOXIDE
Product Characteristics
Color brown Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63931-4443-1 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 06/02/2021
Labeler — Nanophase Technologies Corporation (623502044)
Registrant — Nanophase Technologies Corporation (623502044)
Establishment
Name Address ID/FEI Operations
Nanophase Technologies Corporation 050383046 api manufacture (63931-4443)
Establishment
Name Address ID/FEI Operations
Nanophase Technologies Corporation 623502044 api manufacture (63931-4443), manufacture (63931-4443), pack (63931-4443)
Establishment
Name Address ID/FEI Operations
Amcol Health & Beauty Solutions 872684803 api manufacture (63931-4443)

Revised: 09/2021 Nanophase Technologies Corporation

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