OIL CONTROL MATTIFIER SPF 15 (ENSULIZOLE, OCTINOXATE, OCTINOXATE) CREAM [MURAD INC]

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OIL CONTROL MATTIFIER SPF 15 (ENSULIZOLE, OCTINOXATE, OCTINOXATE) CREAM [MURAD INC]
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NDC 70381-001-10
Set ID 6bcfe453-83db-4357-92c2-5c32ddce19ca
Category HUMAN OTC DRUG LABEL
Packager Murad, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • Drug Facts

  • Active ingredients

    Ensulizole 1.0%

    Octinoxate 7.5%

    Zinc Oxide 3.0%

    Purpose

    Sunscreen

  • Use

    • helps prevent sunburn
  • Warnings

    Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

    For external use only

    Do not use

    on damaged or broken skin

    When using this product

    keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor

    • if skin rash occurs

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure • reapply at least every 2 hours and immediately after towel drying, swimming, or sweating to avoid lowering protection • children under 6 months: Ask a doctor

  • Inactive ingredients

    Water (Aqua), Cyclopentasiloxane, Bis-PEG/PPG-14/14 Dimethicone, Dimethicone Crosspolymer, Urea, Yeast Amino Acids, Trehalose, Inositol, Taurine, Betaine, Phospholipids, Retinyl Palmitate, Tocopheryl Acetate, Ascorbyl Palmitate, Polyglyceryl-3 Polydimethylsiloxyethyl
    Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Farnesyl Acetate, Panthenyl Triacetate, Argania Spinosa Kernel Oil, Serenoa Serrulata Fruit Extract, Sesamum Indicum (Sesame) Seed Oil, Beta-Sitosterol, Punica Granatum Seed Oil, Capryloyl Glycine, Sarcosine, Cinnamomum Zeylanicum Bark Extract, Aluminum Starch Octenylsuccinate, Ascorbic Acid, Butylene Glycol, Chitosan, Propyl Gallate, Acrylates Copolymer, Magnesium Carbonate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Corn Starch Modified, Zinc Gluconate, Acrylates Crosspolymer, Salix Alba (Willow) Bark Extract, Aminomethyl Propanol, Disodium EDTA, Sodium Chloride, Phenoxyethanol, Chlorphenesin

  • Other information

    • protect this product from excessive heat and direct sun
  • Questions or comments?

    1.800.33.MURAD or Murad.com

  • Package Labeling:

    Inner PackageOuter

  • INGREDIENTS AND APPEARANCE
    OIL CONTROL MATTIFIER SPF 15 
    ensulizole, octinoxate, octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70381-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE10 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
    TREHALOSE (UNII: B8WCK70T7I)  
    INOSITOL (UNII: 4L6452S749)  
    TAURINE (UNII: 1EQV5MLY3D)  
    BETAINE (UNII: 3SCV180C9W)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    FARNESYL ACETATE (UNII: 2ARF3ZNJ1R)  
    PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    SAW PALMETTO (UNII: J7WWH9M8QS)  
    SESAME OIL (UNII: QX10HYY4QV)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    SARCOSINE (UNII: Z711V88R5F)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BUTYLENE GLYCOL 2-LAURATE (UNII: 80K4P9IZ6H)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70381-001-101 in 1 CARTON12/31/2015
    110 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/31/2015
    Labeler - Murad, Inc. (963333807)
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