PAVISE LIP DEFENSE TINTED HYDRATING OIL (HUE 616)- zinc oxide lotion 
B.A.I. Biosciences INC.

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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pavise Lip Defense tinted hydrating oil (hue 616)

pavise Lip Defense tinted hydrating oil (hue 616)

PDP

PAVISE LIP DEFENSE TINTED HYDRATING OIL (HUE 616) 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83100-1762
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
DIAMOND (UNII: 6GRV67N0U2)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
PROPANEDIOL (UNII: 5965N8W85T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83100-1762-21 in 1 CARTON02/17/2023
1NDC:83100-1762-15 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/17/2023
Labeler - B.A.I. Biosciences INC. (083612207)
Registrant - Nanophase Technologies Corporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation050383046api manufacture(83100-1762)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044api manufacture(83100-1762) , manufacture(83100-1762)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation118812921pack(83100-1762)

Revised: 2/2023
Document Id: f4eb6b84-780c-cc4f-e053-2995a90ae9bb
Set id: f4eb6b20-7c26-2942-e053-2a95a90abd31
Version: 1
Effective Time: 20230217
 
B.A.I. Biosciences INC.