PURE FINISH MINERAL TINTED MOISTURIZER SPF 15 FAIR (OCTINOXATE) LOTION [ELIZABETH ARDEN, INC]

PURE FINISH MINERAL TINTED MOISTURIZER SPF 15 FAIR (OCTINOXATE) LOTION [ELIZABETH ARDEN, INC]
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NDC 67938-0906-1, 67938-0906-2
Set ID b19eed59-2d48-4de7-856a-be32051617dc
Category HUMAN OTC DRUG LABEL
Packager Elizabeth Arden, Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • DESCRIPTION

    For all skin types. Sheer, natural coverage. Pure, radiant finish. Pure minerals. Pure comfort. Pure perfection. This microlight mineral tinted moisturizer, infused with minerals, vitamins, and antioxidants brightens and evens out skintone with a hint of sheer, natural color. Instantly transforms skin's appearance with a fresh, luminous glow. SPF 15 sun protection. Oil free. Talc free. Fragrance free.

  • INDICATIONS AND USAGE

    To Use: Smooth on to face before sun exposure.

  • WARNINGS

    WARNING: For external use only. Avoid contact with eyes. Discontinue use if irritation or rash appear. If irritation persists, consult a doctor. Keep out of reach of children. Clinically, dermatologist, and allergy tested.

  • OTC - ACTIVE INGREDIENT

    Active Ingredients: Octinoxate 6.0%, Titanium Dioxide 4.3%, Octisalate 4.0%.

  • INACTIVE INGREDIENT

    Other Ingredients: Water/Aqua/Eau, Dimethicone, Mica, Cetearyl Alcohol, Polyglyceryl-4 Isostearate, Cetyl Dimethicon, Hexyl Laurate, Cetyl PEG/PPG-10/1 Dimethicon, Sodium Stearoyl Lactylate, Squalane, Hydrogenated Polyisobutene, Silene Uniflora Extract, Sodium Hyaluronate, Retinyl Palmitate, Tetrahexyldecyl Ascrobate, Tocopherol, Tocopheryl Acetate, Jojoba Esters, Glycerin, Triethoxycaprylylsilane, Carbomer, Magnesium Aluminum Silicate, Triethanolamine, Trisodium EDTA, Methyparaben, Phenoxyethanol, Propylparaben, Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI77891).

  • DOSAGE & ADMINISTRATION

    Smooth on to face.

  • 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

    Pure Finish Mineral Tinted Moisturizer Carton

    Pure Finish Mineral Tinted Moisturizer Tube

  • INGREDIENTS AND APPEARANCE
    PURE FINISH MINERAL TINTED MOISTURIZER SPF 15 FAIR 
    octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0906
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3 mL  in 50 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.15 mL  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    SQUALANE (UNII: GW89575KF9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MICA (UNII: V8A1AW0880)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    Product Characteristics
    ColorPINK (Fair) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67938-0906-11 in 1 BOX
    1NDC:67938-0906-250 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/26/2010
    Labeler - Elizabeth Arden, Inc (849222187)

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