Label: LUMINIZING MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 20 BLUSH- zinc oxide and titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 December 15, 2014

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  • Unit Carton

    Unit Carton

  • Tube

    Tube

  • ACTIVE INGREDIENT

    Titanium Dioxide 5%

    Zinc Oxide 5%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Uses

    Helps prevent sunburns

    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.

  • BOXED WARNING (What is this?)

    Warnings

    Warnings

    For external use only

    Do not use on damages or broken skin

    Stop use and ask a doctor if rash occurs

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

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away

  • DOSAGE & ADMINISTRATION

    Directions

    apply liberally 15 minutes before sun exposure

    use a water resistant sunscreen if swimming or sweating: Immediately after towel drying.

    reapply at least every 2 hours.

    Children under 6 months. Ask a doctor

    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 value of 15 or higher and other sun protection measure including:

    limit time in the sun, especially from 10 a.m. to 2 p.m.

    wear long-sleeved shirts, pants, hats, and sunglasses

  • OTHER SAFETY INFORMATION

    protect this product from excessive heat and direct sun.

  • ADVERSE REACTIONS

    -you may report a serious adverse reaction to Jouer Customer support, toll free: 1-800-315-5374, M-F, 8am-6pm PST (US and Canada Only)

  • INACTIVE INGREDIENT

    Water, Cyclopentasiloxane, Propylene Glycol, Octyldodecyl Neopentanoate, PEG/PPG 18/18 Dimethicone, Dimethicone, 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, Tetrahexyldecyl Ascorbate, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Boron Nitride, Glycerin, Palmitic Acid, Dextrin Palmitate, Sodium Hyaluronate, Butylene Glycol, Sodium Dehydroacetate, Phenoxyethanol, Methylparaben, Propylparaben, Mica, Titanium Dioxide (CI 77891), Iron Oxide (CI 77491, CI77492, CI77499)

  • INGREDIENTS AND APPEARANCE
    LUMINIZING MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 20  BLUSH
    zinc oxide and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69017-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.0 mg  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION5.0 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    LYSINE (UNII: K3Z4F929H6)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    GINKGO (UNII: 19FUJ2C58T)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    PHYTANTRIOL (UNII: 8LVI07A72W)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69017-301-021 in 1 BOX
    1NDC:69017-301-0150 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/01/2014
    Labeler - Jouer Cosmetics LLC (011002088)
    Registrant - Jouer Cosmetics LLC (011002088)
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