Label: JAFRA SUN TINTED FACE PROTECTOR SUNSCREEN BROAD SPECTRUM 50- avobenzone, homosalate, octisalate, octocrylene cream

  • NDC Code(s): 68828-293-01, 68828-293-02
  • Packager: Jafra Cosmetics Internationl
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 29, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Avobenzone 3%..............Sunscreen

    Homosalate 10%.............Sunscreen

    Octisalate 5%..................Sunscreen

    Octocrylene 10%.............Sunscreen

  • PURPOSE

    • 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 doctorif rash occurs.

  • WARNINGS

    For external use only

    Do not useon damaged or broken skin

    When using this productkeep out of eyes. Rinse with water to remove.

  • DOSAGE & ADMINISTRATION

    • 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 value 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-sleeved shirts, pants, hats, and sunglasses

  • INACTIVE INGREDIENT

    Acrylates/Ammonium Methacrylate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Bisabolol, Cellulose Acetate, Cetyl Alcohol, Dicaprylyl Carbonate, Disodium EDTA, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Iron Oxides/CI 77491/CI 77492/CI 77499, Magnesium Stearate, Propylene Glycol Stearate, Panthenol, PEG-100 Stearate, Phenoxyethanol, Polyester-8, Sambucus Nigra (Elderberry) Fruit Extract, Styrene/Acrylates Copolymer, Titanium Dioxide (CI 77891 ), Tocopheryl Acetate, VP/Eicosene Copolymer, Water/Aqua

  • OTHER SAFETY INFORMATION

    Protect this product from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL

    JAFRA

    SUN

    50+

    tinted face protector suncreen broad spectrum SPF 50+

    Water Resistant (40 minutes)

    50 ml e 1.7 FL OZ (US)

    Sun tinted Face protector SPF 50

  • INGREDIENTS AND APPEARANCE
    JAFRA SUN TINTED FACE PROTECTOR SUNSCREEN BROAD SPECTRUM 50 
    avobenzone, homosalate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-293
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 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
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    EUROPEAN ELDERBERRY (UNII: BQY1UBX046)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ARGININE (UNII: 94ZLA3W45F)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-293-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product01/14/2021
    2NDC:68828-293-027.5 mL in 1 BOTTLE; Type 0: Not a Combination Product01/14/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/14/2021
    Labeler - Jafra Cosmetics Internationl (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Distribuidora Comercial Jafra, S.A. de C.V.951612777manufacture(68828-293)