Label: CC CREME CONCEALER BROAD SPECTRUM SPF 20 JAFRA- avobenzone, homosalate, octisalate, octocrylene cream

  • Category: HUMAN OTC DRUG LABEL

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 April 4, 2019

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  • ACTIVE INGREDIENT

    Active ingredients        Purpose

    Avobenzone 3%        Sunscreen

    Homosalate 5%         Sunscreen

    Octisalate 5%            Sunscreen

    Octocrylene 7%         Sunscreen

  • PURPOSE

    Uses

    helps prevent sunburn

    if used as directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin aging

  • 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.

  • 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 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 sleeve shirts, pants, hats, and sunglasses

  • INACTIVE INGREDIENT

    Inactive ingredients

    Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Diisopropyl Dimer Dilinoleate, Ozokerite, Euphorbia Cerifera (Candelilla) Wax/Candelilla Cera, Bis-Stearyl Dimethicone, Copernicia Cerifera (Carnauba) Wax, Beeswax- /Cera Alba, Ricinus Communis (Castor) Seed Oil, Stearalkonium Hectorite, Propylene Carbonate, Oryza Sativa (Rice) Bran Extract, Aluminum Starch Octenylsuccinate, Lauroyl Lysine, Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Anuus (Sunflower) Extract, Tocopherol, Silica Silylate, Cucumis Sativus Extract, Glycyrrhiza Glabra Extract, Biosaccharide Gum-4, Chondrus Crispus (Carrageenan) Extract, Water [May Contain +/-: Iron Oxides/CI 77491/CI 77492/CI 77499, Titanium Dioxide/CI 77891]

  • PRINCIPAL DISPLAY PANEL

    CC Creme Concealer Broad Spectrum SPF 20

    1.8g Net wt. .06 oz

    CC creme carton back

    CC creme carton front

  • INGREDIENTS AND APPEARANCE
    CC CREME CONCEALER BROAD SPECTRUM SPF 20  JAFRA
    avobenzone, homosalate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-241
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    CERESIN (UNII: Q1LS2UJO3A)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    RICE BRAN (UNII: R60QEP13IC)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    ROSEMARY (UNII: IJ67X351P9)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CUCUMBER (UNII: YY7C30VXJT)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
    CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
    WATER (UNII: 059QF0KO0R)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-241-021 in 1 CARTON08/11/2015
    1NDC:68828-241-011.8 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/11/2015
    Labeler - Jafra Cosmetics International (041676479)
    Registrant - Jafra Cosmetics International (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jafra Manufacturing, S.A. de C.V814732061manufacture(68828-241)