EARTH LONG WEAR MAKEUP BROAD SPECTRUM SPF 20 (OCTISALATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL]

EARTH LONG WEAR MAKEUP BROAD SPECTRUM SPF 20 (OCTISALATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL]
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NDC 68828-336-01, 68828-336-02
Set ID 965e2f3d-05be-441d-99f2-478c45de4d1c
Category HUMAN OTC DRUG LABEL
Packager JAFRA COSMETICS INTERNATIONAL
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active

    Ingredients          Purpose

    Octisalate 3% ...... Sunscreen

    Zinc Oxide 6.82% .... Sunscree

  • PURPOSE

    Uses

    • helps prevent suburn
    • 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

    Warnings

    • For external use only
    • Do not use on damaged or broken skin
    • When using this product keep 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 or 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, 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-sleeve shirts, pants, hats, and sunglasses
  • INACTIVE INGREDIENT

    Water/Aqua, Triethoxycaprylylsilane, Caprylic Capric Triglyceride, Polyhydroxystearic Acid, Cyclomethicone, Hydroxypropylcocoate PEG-8 Dimethicone, Phenyl Triemthicone, C12-15 Alkyl Benzoate, Dimethicone, Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Phenyl Dimethicone, Di-PPG-3 Myristyl Ether Adipate, Caprylyl Methicone, Dimethicone, PEG-10 Dimethicone, Disteardimonium Hectorite, Propanediol, Sodium Chloride, Squalane, Boron Nitride, Synthetic Fluorophlogopite, Aloe Barbadensis Leaf Juice, DMDM Hydantoin, Dextrin Palmitate, Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Anuus (Sunflower) Extract, Tocopherol, Tocopheryl Acetate, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Sodium Hyaluronate, Butylene Glycol, Glycyrrhiza Glabra (Licorice) Extract, Benzimidazole Diamond Amidoethyl Urea Carbamoyl Propyl Polymehtylsilsesquioxane, Lentinus Edodes (shiitake) Extract, Ipomoea Batatas Tuber Extract, Centella Asiatica Extract, Withania Somniferia Extract, Butylene Glycol, Biosaccharide Gum-4, Smithsonite Extact, Chondrus Crispus (Carrageenan) Extract [ May Containt +/-: Titanium Dioxide, Iron Oxides/ CI 77492/ CI 77491/ CI 77499]

  • PRINCIPAL DISPLAY PANEL

    JAFRA

    Long Wear Makeup

    Broad Spectrum SPF 20

    30 ml / 1 FL oz (us)

    Label

  • INGREDIENTS AND APPEARANCE
    EARTH LONG WEAR MAKEUP   BROAD SPECTRUM SPF 20
    octisalate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-336
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION6.82 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SQUALANE (UNII: GW89575KF9)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    RICE BRAN (UNII: R60QEP13IC)  
    ROSEMARY (UNII: IJ67X351P9)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    LENTINULA EDODES MYCELIUM (UNII: CU2S39TB8O)  
    SWEET POTATO (UNII: M9WGG9Z9GK)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
    CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-336-021 in 1 BOX07/07/2015
    1NDC:68828-336-0130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/07/2015
    Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
    Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jafra Manufacturing, S.A. de C.V814732061manufacture(68828-336)

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