MALLY FACE DEFENDER FOUNDATION BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]

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MALLY FACE DEFENDER FOUNDATION BB (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALLYGIRL, LLC]
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NDC 76119-1444-1
Set ID dcd61aca-6188-4ba2-921c-02f4cdd189b0
Category HUMAN OTC DRUG LABEL
Packager MallyGirl, LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • mally Face Defender BB - Medium Tan


  • 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 Crosspolymer, 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)

  • Other Information

    • Protect this product from excessive heat and direct sun.
  • SPL UNCLASSIFIED SECTION

    Distibuted by Mallygirl LLC

    P.O. Boxy 42727

    Baltimore, MD 21284-2727

    Product made in USA

  • Principal Display Panel

    mally

    Face Defender BB

    cream foundation

    BROAD SPECTRUM SPF 15

    Tube

    Tube Label

    Box

    Drug Facts Label Box

  • INGREDIENTS AND APPEARANCE
    MALLY FACE DEFENDER FOUNDATION BB 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76119-1444
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.39 mg  in 53.2 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.59 mg  in 53.2 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (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)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    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)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76119-1444-11 in 1 BOX
    153.2 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/03/2014
    Labeler - MallyGirl, LLC (167262554)
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