Label: TOO FACED TINTED BEAUTY BALM SPF-20- titanium dioxide and zinc oxide cream

  • NDC Code(s): 79596-090-21, 79596-090-22
  • Packager: TOO FACED COSMETICS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    TITANIUM DIOXIDE 5.0%

    ZINC OXIDE 5.0%

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  • PURPOSE

    PURPOSE

    SUNSCREEN

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  • INDICATIONS & USAGE

    USE

    • HELPS PREVENT SUNBURN
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  • WARNINGS

    WARNINGS

    FOR EXTERNAL USE ONLY

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  • DO NOT USE

    DO NOT USE ON DAMAGED OR BROKEN SKIN.

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  • STOP USE

    STOP USE AND ASK DOCTOR IF RASH OCCURS.

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  • WHEN USING

    WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

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  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • APPLY LIBERALLY AND SMOOTHLY 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.
    • OPTIONAL: APPLY TO ALL SKIN EXPOSED TO THE SUN.
    • SUN PROTECTION MEASURES. SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SPF OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:
    • LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 A.M. - 2 P.M.
    • WEAR LONG-SLEEVED SHIRTS, PANTS, HATS AND SUNGLASSES.
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  • OTHER SAFETY INFORMATION

    OTHER INFORMATION

    • YOU MAY REPORT A SERIOUS ADVERSE REACTION TO:
      17361 ARMSTRONG AVENUE
      IRVINE, CA 92614
    • PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUNLIGHT.
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  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    WATER, CYCLOPENTASILOXANE, PROPYLENE GLYCOL, OCTYLDODECYL NEOPENTANOATE, PEG/PPG-18/18 DIMETHICONE, DIMETHICONE, CYCLOHEXASILOXANE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, ZINC CHLORIDE, LYSINE, PANAX GINSENG ROOT EXTRACT, GINKGO BILOBA LEAF EXTRACT, ANTHEMIS NOBILIS FLOWER EXTRACT, CAMELLIA OLEIFERA LEAF EXTRACT, PHYTANTRIOL, MAGNESIUM ASCORBYL PHOSPHATE, RETINYL PALMITATE, TOCOPHERYL ACETATE, TOCOPHEROL, TETRAHEXYDECYL ASCORBATE, ALUMINUM HYDROXIDE, STEARIC ACID, TRIETHOXYCAPRYLYLSILOXANE, BORON NITRIDE, GLYCERIN, SODIUM DEHYDROACETATE, PALMITIC ACID, DEXTRIN PALMITATE, SODIUM HYALURONATE, BUTYLENE GLYCOL, PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, MICA, IRON OXIDES.

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  • QUESTIONS

    QUESTIONS?

    (949) 553-4431

    MON-FRI 9AM-5PM (PST)

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  • INGREDIENTS AND APPEARANCE
    TOO FACED TINTED BEAUTY BALM  SPF-20
    titanium dioxide zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:79596-090
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 5 g  in 100 mL
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    CYCLOMETHICONE 5  
    PROPYLENE GLYCOL  
    OCTYLDODECYL NEOPENTANOATE  
    PEG/PPG-18/18 DIMETHICONE  
    DIMETHICONE  
    CYCLOMETHICONE 6  
    MAGNESIUM CHLORIDE  
    POTASSIUM CHLORIDE  
    SODIUM CHLORIDE  
    ZINC CHLORIDE  
    LYSINE  
    PANAX GINSENG ROOT WATER  
    GINKGO BILOBA WHOLE  
    CHAMAEMELUM NOBILE FLOWER  
    CAMELLIA OLEIFERA LEAF  
    PHYTANTRIOL  
    MAGNESIUM ASCORBYL PHOSPHATE  
    VITAMIN A PALMITATE  
    .ALPHA.-TOCOPHEROL ACETATE  
    TOCOPHEROL  
    TETRAHEXYLDECYL ASCORBATE  
    ALUMINUM HYDROXIDE  
    STEARIC ACID  
    TRIETHOXYCAPRYLYLSILANE  
    BORON NITRIDE  
    GLYCERIN  
    SODIUM DEHYDROACETATE  
    PALMITIC ACID  
    ICODEXTRIN  
    HYALURONATE SODIUM  
    BUTYLENE GLYCOL  
    PHENOXYETHANOL  
    METHYLPARABEN  
    PROPYLPARABEN  
    MICA  
    BROWN IRON OXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:79596-090-22 1 in 1 BOX
    1 NDC:79596-090-21 45 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 12/14/2012
    Labeler - TOO FACED COSMETICS (014131481)
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