WL-AAD-Z-W-2063- 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-AAD-Z-W-2063

WL-AAD-Z-W-2063

GHS

WL-AAD-Z-W-2063 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63931-2063
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE132 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)  
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
RUTIN (UNII: 5G06TVY3R7)  
JASMINUM OFFICINALE LEAF (UNII: 6OG06384ID)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
FERROUS OXIDE (UNII: G7036X8B5H)  
HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)  
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SALVIA OFFICINALIS FLOWERING TOP (UNII: 48JCS720FN)  
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
NYLON-12 (UNII: 446U8J075B)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
ALLANTOIN (UNII: 344S277G0Z)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PROPANEDIOL (UNII: 5965N8W85T)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
JOJOBA OIL (UNII: 724GKU717M)  
ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63931-2063-1150000 mL in 1 DRUM; Type 0: Not a Combination Product08/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/30/2023
Labeler - Nanophase Technologies Corporation (623502044)
Registrant - Nanophase Technologies Corporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation050383046api manufacture(63931-2063)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044api manufacture(63931-2063) , manufacture(63931-2063)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation118812921manufacture(63931-2063) , pack(63931-2063)

Revised: 8/2023
Document Id: 042268d3-747a-3cbb-e063-6294a90a5452
Set id: 0422a5a3-b188-cec6-e063-6294a90a5c02
Version: 1
Effective Time: 20230830
 
Nanophase Technologies Corporation