FACE PROTECTOR BROAD SPECTRUM SPF 40 JAFRA (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]

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  • FACE PROTECTOR BROAD SPECTRUM SPF 40 JAFRA (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]

FACE PROTECTOR BROAD SPECTRUM SPF 40 JAFRA (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]
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NDC 68828-167-01, 68828-167-02
Set ID c257dfc3-f15e-48ab-a1e5-04696f9c47d8
Category HUMAN OTC DRUG LABEL
Packager Jafra Cosmetics International Inc
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active ingredients        Purpose

    Octinoxate  7.5 %           Sunscreen

    Octisalate 5%                 Sunscreen

    Octocrylene 1.5%            Sunscreen

    Oxybenzone 2%               Sunscreen

    Titanium Dioxide 4.25%    Sunscreen

    Zin Oxide 2.9%                Sunscreen

    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

    warning

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

    indications

    · 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 product keep out of eyes. Rinse with water to remove.

    Directions

    · Apply liberally 15 minutes before sun exposure

    · Reapply at least every 2 hours
    · Use a water resistant sunscreen if swimming or sweating
    · 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 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 ingredients

    Adipic Acid/Diglycol Crosspolymer, Alumina, Avena Sativa (Oat) Kernel Extract, Beeswax/Cera Alba, Butylene Glycol, C12-15 Alkyl Benzoate, Cetyl Alcohol, Dimethicone, Dimethicone Copolyol, DMDM Hydantoin, Ethylhexyl Ethylhexanoate, Fragrance/Parfum, Glyceryl Stearate SE, Iodopropyl Butylcarbamate, Iron Oxides/CI 77491/CI 77492/CI 77499, Panthenol, PEG-4 Laurate, Peg-12 Dimethicone, PVP/Eicosene Copolymer, Sodium Dihydroxycetyl Phosphate Tocopheryl Acetate, Trisodium EDTA, Water/Aqua, Xanthan Gum

  • Principle Display

    Jafra Sun

    Face Protector Broad Spectrum SPF 40

    UVA/UVB Protection

    Cont. Net. 50 ml 1.7 FL OZ (US)

    carton

  • INGREDIENTS AND APPEARANCE
    FACE PROTECTOR BROAD SPECTRUM SPF 40  JAFRA
    octinoxate, octisalate, octocrylene, oxybenzone, titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-167
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.5 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.25 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.9 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    OAT (UNII: Z6J799EAJK)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ETHYLHEXYL ETHYLHEXANOATE (UNII: 430RJA6715)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    SODIUM DIHYDROXYCETYL PHOSPHATE (UNII: YWI33EV595)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-167-021 in 1 CARTON04/05/2013
    1NDC:68828-167-0150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/05/2013
    Labeler - Jafra Cosmetics International Inc (041676479)
    Registrant - Jafra Cosmetics International Inc (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-167)
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