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mally Face Defender Foundation (MallyGirl, LLC)

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CREAM 1 TUBE in 1 BOX (76119-1325-1) > 59.2 mL in 1 TUBE Label Information

Complete mally Face Defender Foundation Information

  • DRUG FACTS



  • Active Ingredients

    Titanium Dioxide 4.50%

    Zinc Oxide 3.00%


  • Purpose

    Sunscreen

    Sunscreen


  • Use

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • WARNINGS

    For external use only


  • DO NOT USE

    Do not use on damaged or broken skin.


  • STOP USE

    Stop use and ask doctor if rash occurs.


  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swollowed, get medical help or contact a Poison Control Center right away.


  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Use a water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours
    • Children under 6 months: ask a doctor
    • Sun Protection Measures. Spending time in the sun increases risk of skin cancer and early aging. To decrease this risk regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higer and other sun protection measures including
    • Limit time in the sun especially from 10:00 a.m. - 2:00 p.m.
    • Wear long sleeved shirts, pants, hats and sunglasses

  • Inactive Ingredients

    Water (Aqua), Cyclopentaslloxane, Octyldodecyl Neopentanoate, Butylene Glycol, Glycerin, Polyglyceryl-4 Isostearate, Dimethicone Corsspolymer, PEG/PPG 18/18 Dimethicone, Silica, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Stearic Acid, Aluminum Hydroxide, Sodium Dehydroacetate, Phytantriol, Hexyl Laurate, Triethoxycaprylylsilane, Nylon-12, Carbomer, Polysorbate 20, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Sodium Chloride, Tocopherol, Tetrahexyldecyl Ascorbate, Nylon-12 Fluorescent Brightener 230 Salt, Polyvinylalconol Crosspolymer, Magnesium Chloride, Potassium Chloride, Zinc Chloride, Lysine, Sodium Hyaluronate, Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol, Potassium Sorbate, May Contain: Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499) Product made in the USA


  • Other Information

    • Protect this product from excessive heat and direct sun.

  • Principal Display Panel

    mally

    Face Defender Foundation
    Fair
    Broad Specturm SPF 15


    Tube Label

    Drug Facts Label Carton



  • INGREDIENTS AND APPEARANCE
    MALLY FACE DEFENDER FOUNDATION 
    titanium dioxide, zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:76119-1325
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.39 mL  in 53.2 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.59 mL  in 53.2 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    POLYETHYLENE GLYCOL 900 (UNII: UEP843BRCQ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    PHYTANTRIOL (UNII: 8LVI07A72W)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    NYLON-12 (UNII: 446U8J075B)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    LYSINE (UNII: K3Z4F929H6)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76119-1325-1 1 in 1 BOX
    1 59.2 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 03/29/2012
    Labeler - MallyGirl, LLC (167262554)