ELEVEN UNRIVALED SERUM- zinc oxide lotion 
Eco Chic, LLC

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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ELEVEN UNRIVALED SERUM

ELEVEN UNRIVALED SERUM

PDP

ELEVEN UNRIVALED SERUM 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79163-399
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
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)  
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)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79163-399-021 in 1 CARTON11/01/2022
1NDC:79163-399-0128 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:79163-399-038 mL in 1 BOTTLE; 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 - Eco Chic, LLC (097807096)
Registrant - Nanophase Technologies Corporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation050383046api manufacture(79163-399)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044api manufacture(79163-399) , manufacture(79163-399)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation118812921manufacture(79163-399) , pack(79163-399)

Revised: 3/2023
Document Id: f6541d38-3524-9c03-e053-2995a90a8c34
Set id: f4bdacb9-bedd-c9cc-e053-2995a90a5786
Version: 2
Effective Time: 20230307
 
Eco Chic, LLC