Label: NO MAKEUP LIPSTICK (WINE) SPF15- zinc oxide lipstick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated April 14, 2022

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  • ACTIVE INGREDIENT

    Carton1

  • INACTIVE INGREDIENT

    carton2

  • KEEP OUT OF REACH OF CHILDREN

    carton3

  • PURPOSE

    carton4

  • INDICATIONS & USAGE

    -651145_CPPP_Neck_1oz_Jar_FC_US_v05_page-0001

  • OTHER SAFETY INFORMATION

    451227_NM_Lipstick_WINE_0.15oz_BtmLbl_GL_v05_compressed_page-0001

  • DOSAGE & ADMINISTRATION

    Carton

  • PRINCIPAL DISPLAY PANEL

    651188_NM_Lipstick_WINE_0.15oz_FC_US_v06_compressed_page-0001

  • INGREDIENTS AND APPEARANCE
    NO MAKEUP LIPSTICK (WINE) SPF15 
    zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45634-461
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.1764 g  in 4.2 g
    Inactive Ingredients
    Ingredient NameStrength
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    CERESIN (UNII: Q1LS2UJO3A)  
    VANILLIN (UNII: CHI530446X)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    DIMER DILINOLEYL DIMER DILINOLEATE (UNII: 0E2D5DBT7M)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PEG-8 BEESWAX (UNII: 3C1QUF1TIR)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)  
    HYDROGENATED JOJOBA OIL (UNII: 7F674YQ5SO)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorVANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45634-461-5224.7 g in 1 APPLICATOR; Type 0: Not a Combination Product04/14/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/14/2022
    Labeler - N.V Perricone LLC (054414243)