Label: CARAMEL RADIANCE FOUNDATION BROAD SPECTRUM SPF 20 - TAWNY JAFRA- octinoxate, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 1, 2019

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  • ACTIVE INGREDIENT

    Octinoxate 3% .................. Sunscreen

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

  • PURPOSE

    Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions
  • 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

    • apply liberally 15 minutes befor 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 the this risk, regularly use a sunscreen with a Broad Spectrum SPF 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleev shirts, pants, hats, and sunglasses
  • INACTIVE INGREDIENT

    Water/Aqua, Titanium Dioxide, Triethoxycaprylysilane, Caprylic Capric Triglyceride, Polyhydroxystearic Acid, Cyclomethicone, Hydroxypropylcocoate PEG-8 Diemthicone, C12-15 Alkyl Benzoate, Phenyl Dimethicone, Phenyl Trimethicone, Cyclopentasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Squalane, Di-PPG-3 Myristyl Ether Adipate Caprylyl Methicone, Dimethicone, PEG-10 Dimethicone, Disteardimonium Hectorite, Boron Nitride, Royal Jelly, Propanediol, Sodium Chloride, DMDM Hydantoin, Dextin Palmitate, Oryza Sativa (Rice) Bran Extract, Rosamarinus Officinalis (Rosemary) Leaf Extract, Helianthus Anuus (Sunflower) Extract, Tocopherol, Panthenol, Tocopheryl Acetate, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Withania Somniferia (Winter Cherry) Extract, Nelumbo Nucifera (Lotus) Extract, Biosacchardie Gum-4, Chondrus Crispus (Carrageenan) Extract, Smithsonite Extract, Iron Oxides/CI 77491/CI 77492/CI 77499

  • PRINCIPAL DISPLAY PANEL

    JAFRA

    Royal Jelly

    Raidiance Foundation

    Broad Spectrum SPF 20

    30 ml   1 FL OZ (US)

    Box

  • INGREDIENTS AND APPEARANCE
    CARAMEL RADIANCE FOUNDATION BROAD SPECTRUM SPF 20 - TAWNY  JAFRA
    octinoxate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-259
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION6.8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    SQUALANE (UNII: GW89575KF9)  
    DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    ROYAL JELLY (UNII: L497I37F0C)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    RICE BRAN (UNII: R60QEP13IC)  
    ROSEMARY (UNII: IJ67X351P9)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
    CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-259-021 in 1 BOX02/21/2017
    1NDC:68828-259-0130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/21/2017
    Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
    Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jafra Manufacturing, S.A. de C.V814732061manufacture(68828-259)
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