MATTE MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 15 CHAMOMILE (ZINC OXIDE AND TITANIUM DIOXIDE) CREAM [JOUER COSMETICS LLC]

MATTE MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 15 CHAMOMILE (ZINC OXIDE AND TITANIUM DIOXIDE) CREAM [JOUER COSMETICS LLC]
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NDC 69017-204-01, 69017-204-02
Set ID be1be3a1-047d-4dc9-8172-8b8123f1bc51
Category HUMAN OTC DRUG LABEL
Packager Jouer Cosmetics LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • Unit Carton

    Unit Carton

  • Tube

    Tube

  • ACTIVE INGREDIENT

    Titanium Dioxide 4.5%

    Zinc Oxide 3.0%

  • 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

    INACTIVE INGREDIENTS: WATER (AQUA), CYCLOPENTASILOXANE, OCTYLDODECYL NEOPENTANOATE, BUTYLENE GLYCOL, 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, SODIUM CHLORIDE, RETINYL PALMITATE, TOCOPHEROL, TETRAHEXYLDECYL ASCORBATE, POLYDODECANAMIDEAMINIUM TRIAZADIPHENYLETHENESULFONATE, POLYVINYLALCOHOL CROSSPOLYMER, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, ZINC CHLORIDE, LYSINE, SODIUM HYALURONATE, PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, ETHYLPARABEN, BUTYLPARABEN, ISOPROPYLPARABEN, POTASSIUM SORBATE. MAY CONTAIN (+/-): MICA, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499).

  • INGREDIENTS AND APPEARANCE
    MATTE MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 15  CHAMOMILE
    zinc oxide and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69017-204
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.5 mg  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION3.0 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
    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)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    LYSINE (UNII: K3Z4F929H6)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ISOPROPYLPARABEN (UNII: A6EOX47QK0)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    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:69017-204-021 in 1 BOX
    1NDC:69017-204-0150 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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