Label: BAUME PRODIGIEUX LEVRES 02 LEGENDAIRE PINK NUTRI-PROTECTING LIP CARE SPF 15- octinoxate, avobenzone 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 December 1, 2009

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  • ACTIVE INGREDIENT

    OCTINOXATE (7.3%), AVOBENZONE (2.9%)

  • PURPOSE

    Provides moderate protection against sunburn.

  • PRINCIPAL DISPLAY PANEL


    ACTIVE INGREDIENTS : OCTINOXATE (7.3%), AVOBENZONE (2.9%)

    WARNINGS : Provides moderate protection against sunburn. Stop and ask a doctor if rash or irritation develops and lasts.


    image of carton label



  • INGREDIENTS AND APPEARANCE
    BAUME PRODIGIEUX LEVRES 02 LEGENDAIRE PINK  NUTRI-PROTECTING LIP CARE SPF 15
    octinoxate, avobenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67542-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.3 mL  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.9 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    MICA (UNII: V8A1AW0880)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    C20-40 ACID (UNII: CKJ5537111)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    TRIHYDROXYPALMITAMIDOHYDROXYPROPYL MYRISTYL ETHER (UNII: NQ0RNU9701)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67542-020-027 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/01/2007
    Labeler - LABORATOIRE NUXE (260352379)
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