DARK CC CREME BROAD SPECTRUM SPF 15 JAFRA (ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL]

DARK CC CREME BROAD SPECTRUM SPF 15 JAFRA (ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL]
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NDC 68828-237-01, 68828-237-02
Set ID 820f5504-0320-439a-81dd-b1b4f7e5bd47
Category HUMAN OTC DRUG LABEL
Packager Jafra Cosmetics International
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active

    ingredients                   Purpose

    Zinc Oxide 6.8% ......... Sunscreen

  • PURPOSE

    Uses

    • 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
  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs

  • WARNINGS

    • For external use only
    • Do not use on damaged or broken skin
    • When using this productkeep out of eyes. Rinse with water to remove.
  • DOSAGE & ADMINISTRATION

    Directions

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming of sweating
    • 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, regularyl 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-sleeve shirts, pants, hats, and sunglasses
  • INACTIVE INGREDIENT

    Water/Aqua, Cyclopentasiloxane, PEG/PPG-18/18 Dimethicone, Cyclomethicone, Caprylic Capric Triglyceride, Polyhyroxystearic Acid, Propanediol, Titanium Dioxide/CI 77891, Triethoxycaprylysilane, Dimethicone, PEG-10 Dimethicone, Disteardimonium Hectorite, Boron Nitride, Iron Oxides/ CI 77491/CI 77492/CI 77499, Methicone, Glycerin, Sodium Chloride, Sodium Dehydroacetate, DMDM Hydantoin, Palmitic Acid, Disodium EDTA, Dextrin, Palmitate, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Cucumis Sativus Extract, Glycrrhiza Glabra Extract, Tocopherol

  • PRINCIPAL DISPLAY PANEL

    Dark

    Jafra

    CC Creme

    Broad Spectrum SPF 15

    30 ml / 1 FL OZ (US)

    Box

  • INGREDIENTS AND APPEARANCE
    DARK CC CREME BROAD SPECTRUM SPF 15  JAFRA
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-237
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION6.8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    CUCUMBER (UNII: YY7C30VXJT)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-237-021 in 1 BOX07/13/2015
    1NDC:68828-237-0130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/13/2015
    Labeler - Jafra Cosmetics International (041676479)
    Registrant - Jafra Cosmetics International (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jafra Manufacturing, S.A. de C.V814732061manufacture(68828-237)

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