Label: INTERVENE RADIANCE BOOSTING MOISTURE SPF 15- octinoxate lotion

  • 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 January 13, 2011

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  • DESCRIPTION

    This multi-benefit moisturizer immediately boosts skin's appearance for a radiant, clear, natural looking glow. With continued use, naturally-derived Biodormin technology supports skin's natural cell metabolism rate to help fight the visible aging effects caused by stress. Helps minimze the look of fine lines and combat the appearance of new ones. Provides deep hydration so skin stays younger looking longer. Clinically, dermatologist, and allergy tested.

  • INDICATIONS AND USAGE

    To Use: Smooth on to cleansed face and throat daily before sun exposure.

  • WARNINGS

    Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rash appear. If irritation or rash persists, consult a doctor. Keep out of reach of children.

  • OTC - ACTIVE INGREDIENT

    Active Ingredients: Octinoxate 7.5% w/w, Avobenzone 3.0% w/w, Oxybenzone 3.0% w/w.

  • INACTIVE INGREDIENT

    Other Ingredients: Water/Aqua/Eau, Ethylhexyl Methoxycinnamite, C12-15 Alkyl Benzoate, Glycerin, Ceteareth-6 Olivate, Butylene Glycol, Benzophenone-3, Butyl Methoxydibenzoylmethane, Pentylene Glycol, Tridecyl Salicylate, Caprylice/Capric Triglyceride, PEG-11 Methyl Ehter Dimethcone, Dimethicone, Narcissus Tazetta Bulb Extract, Trifolium Pratense (Clover) Flower Extract, Sodium Hyaluronate, Tocopherol, Tocopheryl Acetate, Caprylyl Methicone, Caprylyl Glycol, Ethylhexyl Palmitate, PEG-40 Hydrogenated Castor Oil, Propylene Glycol, Sodium PCA, Trehalose, Urea, Hydrolyzed Soy Protein, Lecithin, Palmitoyl Tetrapeptide-7, PEG/PPG-18/18 Dimethicone, PEG-8 Laurate, Steareth-20, Trideceth-6, Trideceth-9, Sodium Dodecylbenzenesulfonate, Polyquaternium-51, Styrene/Acrylates Copolymer, Hexylene Glycol, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Hydroxyethylcellulose, Sodium Polyacrylate, Xanthan Gum, Nylon-12, Triethanolamine, Disodium EDTA, Mica, Tin Oxide, Cyclopentasiloxane, Silica, Dimethyl Silylate, Parfum/Fragrance, Butylphenyl Methylpropional, Citronellol, Limonene, Linalool, Benzoic Acid, Methylparaben, Phenoxyethanol, Potassium Sorbate, Chlorhexidine Digluconate, Chlorphenesin, O-Cymen-5-ol, Titanium Dioxide (CI77891).

  • DOSAGE & ADMINISTRATION

    Smooth on to face and throat.

  • OTC - KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OTC - PURPOSE

    Provides SPF 15 sun protection.

  • OTC - WHEN USING

    Avoid contact with eyes.

  • PRINCIPAL DISPLAY PANEL

    Intervene Radiance Boosting Moisture Lotion Carton

    Intervene Radiance Boosting Moisture Lotion Bottle

  • INGREDIENTS AND APPEARANCE
    INTERVENE RADIANCE BOOSTING MOISTURE SPF 15 
    octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0808
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 mL  in 50 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 mL  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1.5 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    UREA (UNII: 8W8T17847W)  
    MICA (UNII: V8A1AW0880)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    NARCISSUS TAZETTA BULB (UNII: K17762966S)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    O-CYMEN-5-OL (UNII: H41B6Q1I9L)  
    TREHALOSE (UNII: B8WCK70T7I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67938-0808-11 in 1 BOX
    1NDC:67938-0808-250 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/18/2009
    Labeler - Elizabeth Arden, Inc (849222187)