WL-AAD-Z-W-1399- 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-1399

WL-AAD-Z-W-1399

GHS Label

WL-AAD-Z-W-1399 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63931-4527
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE110 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRUS NOBILIS (UNII: 8MFF77J91V)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
RUTIN (UNII: 5G06TVY3R7)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
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)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
VANILLA PLANIFOLIA WHOLE (UNII: BOS0R5Y21O)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)  
COCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
HEDYCHIUM SPICATUM WHOLE (UNII: V88105URGI)  
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)  
PROPANEDIOL (UNII: 5965N8W85T)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63931-4527-1150000 mL in 1 DRUM; Type 0: Not a Combination Product11/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/01/2022
Labeler - Nanophase Technologies Corporation (623502044)
Registrant - Nanophase Technologies Corporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation050383046api manufacture(63931-4527)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044api manufacture(63931-4527) , manufacture(63931-4527) , pack(63931-4527)

Revised: 2/2023
Document Id: f4ae9ed6-293c-f2f0-e053-2a95a90a14ee
Set id: f4ae9ed6-293e-f2f0-e053-2a95a90a14ee
Version: 1
Effective Time: 20230214
 
Nanophase Technologies Corporation