Label: SKIN ACTIVATOR LIP REFINER SPF 15- octinoxate, octisalate and avobenzone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 November 23, 2011

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS
    Octinoxate (7%)
    Octisalate (5%)
    Avobenzone (1.5%)

  • DOSAGE & ADMINISTRATION

    DIRECTIONS
    Smooth onto lips daily.
    Apply prior to sun exposure

  • WARNINGS

    WARNINGS
    For external use only.

    Keep out of reach of children.
    Use on children under 2 years of age only with the advice of physician.

    Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Discontinue use if signs of irritation or rush occurs. If irritation or rash persist, consult a doctor.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    Water
    Glycerin
    Isopropyl isostearate
    Beeswax (cera alba)
    Diisopropyl dimer dilinoleate
    Butyrospermum parkii (shea) butter
    Dimethicone
    Cetearyl alcohol
    Ceteareth 20
    Sodium pca
    Squalane
    Dipalmitoyl hydroxyproline
    Glucosamine hydrochloride
    Algae extract
    Yeast extract
    Urea
    Ethylhexyl palmitate  
    Tribehenin
    Sorbitan isostearate
    Palmitoyl oligopeptide
    Tocopherol acetate
    Tetrahexyldecyl ascorbate
    Bisabolol
    Camellia sinensis  leaf extract
    Xanthan gum
    Glyceryl stearate  
    Peg 100 stearate
    Mentha piperita (peppermint) oil
    Tetrasodium edta
    Fragrance (parfum)

  • PRINCIPAL DISPLAY PANEL


    Outer label Image

    Inner label image


  • INGREDIENTS AND APPEARANCE
    SKIN ACTIVATOR  LIP REFINER SPF 15
    octinoxate, octisalate and avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63509-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0661 g  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.0472 g  in 1 mL
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.0142 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)  
    Yellow wax (UNII: 2ZA36H0S2V)  
    Diisopropyl Dilinoleate (UNII: 5323S7S2LR)  
    Shea butter (UNII: K49155WL9Y)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
    Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
    Squalane (UNII: GW89575KF9)  
    Dipalmitoyl hydroxyproline (UNII: E6AHA53N1H)  
    Glucosamine hydrochloride (UNII: 750W5330FY)  
    Laminaria digitata (UNII: 15E7C67EE8)  
    Yeast (UNII: 3NY3SM6B8U)  
    Urea (UNII: 8W8T17847W)  
    Ethylhexyl palmitate (UNII: 2865993309)  
    Tribehenin (UNII: 8OC9U7TQZ0)  
    Sorbitan isostearate (UNII: 01S2G2C1E4)  
    Palmitoyl oligopeptide (UNII: HO4ZT5S86C)  
    Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)  
    Levomenol (UNII: 24WE03BX2T)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Xanthan gum (UNII: TTV12P4NEE)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Peppermint oil (UNII: AV092KU4JH)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63509-002-011 in 1 CARTON
    115 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/21/2011
    Labeler - Cosmint Spa. (444392468)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmint Spa.444392468manufacture
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