WL-AAE-Z-O-1720- 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-Z-O-1720

WL-AAE-Z-O-1720

GHS Label

WL-AAE-Z-O-1720 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63931-4569
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE174 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63931-4569-1150000 mL in 1 DRUM; Type 0: Not a Combination Product02/17/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/17/2023
Labeler - Nanophase Technologies Corporation (623502044)
Registrant - Nanophase Technologies Corporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation050383046api manufacture(63931-4569)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044api manufacture(63931-4569) , manufacture(63931-4569) , pack(63931-4569)

Revised: 4/2023
Document Id: f8fca5a6-5fee-cdc4-e053-6394a90ac45d
Set id: f4e93937-93c5-5d35-e053-2995a90a5a94
Version: 2
Effective Time: 20230410
 
Nanophase Technologies Corporation