SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]

SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]
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NDC 68828-165-01, 68828-165-02, 68828-165-03, 68828-165-04
Set ID 9bf66460-1835-4135-b4be-016ffdabe9a8
Category HUMAN OTC DRUG LABEL
Packager JAFRA COSMETICS INTERNATIONAL
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Avobenzone 3% Sunscreen

    Homosalate 10% Sunscreen

    Octisalate 5% Sunscreen

    Octocrylene 10% Sunscreen

    Oxybenzone 5% 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 by the sun

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

    Stop use and ask a doctor if rash occurs

    Warnings

    For external use only

    Do not use on 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

    use a water resistant sunscreen if swimming or sweating

    reapply at least ever 2 hours, especially if swimming, sweating, or after toweling

    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

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Acrylates/Octylacrylamide Copolymer, Allantoin, Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Arachidyl Glucoside, Arginine, Behenyl Alcohol, Bisabolol, Chlorphenesin, Cyclopentasiloxane, Disodium EDTA, Ethylhexylglycerin, Fragrance/parfum, Glyceryl Stearate, Lauroyl Lysine, Methylisothiazolinone, Mica, Silica, Panthenol, PEG-100 Stearate, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Water/Aqua.

  • PRINCIPAL DISPLAY PANEL

    carton back

    carton front

    Jafra Sun

    50+

    Sunscreen Cream Broad Spectrum SPF 50+

    UVA/UVB Protection

    125 ml 4.2 Fl Oz. (US)

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN BROAD SPECTRUM SPF 50   JAFRA
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-165
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    ARGININE (UNII: 94ZLA3W45F)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    MICA (UNII: V8A1AW0880)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-165-021 in 1 CARTON02/19/2013
    1NDC:68828-165-01125 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68828-165-041 in 1 CARTON02/19/2013
    2NDC:68828-165-03200 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 finalpart35202/19/2013
    Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
    Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-165)

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