Label: WL-AAE-Z-O-1720- zinc oxide lotion
- NDC Code(s): 63931-4569-1
- Packager: Nanophase Technologies Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 10, 2023
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- WL-AAE-Z-O-1720
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INGREDIENTS AND APPEARANCE
WL-AAE-Z-O-1720
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63931-4569 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 174 mg in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) XANTHAN GUM (UNII: TTV12P4NEE) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) ASTAXANTHIN (UNII: 8XPW32PR7I) ISOSTEARIC ACID (UNII: X33R8U0062) PINUS PINASTER WOOD (UNII: 0L1DQ35D6G) PROPANEDIOL (UNII: 5965N8W85T) CETYL ALCOHOL (UNII: 936JST6JCN) OCTYLDODECANOL (UNII: 461N1O614Y) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) PHENOXYETHANOL (UNII: HIE492ZZ3T) SILYBUM MARIANUM SEED (UNII: U946SH95EE) TRANEXAMIC ACID (UNII: 6T84R30KC1) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) NIACINAMIDE (UNII: 25X51I8RD4) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV) ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H) SQUALANE (UNII: GW89575KF9) TRIACONTANYL PVP (WP-660) (UNII: N0SS3Q238D) DIAMOND (UNII: 6GRV67N0U2) DISODIUM ETHYLENEDIAMINEDIACETATE (UNII: EQL53S5L0F) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63931-4569-1 150000 mL in 1 DRUM; Type 0: Not a Combination Product 02/17/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/17/2023 Labeler - Nanophase Technologies Corporation (623502044) Registrant - Nanophase Technologies Corporation (623502044) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 050383046 api manufacture(63931-4569) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 623502044 api manufacture(63931-4569) , manufacture(63931-4569) , pack(63931-4569)
