Label: CC CREAM COMPLEXION CORRECTOR LIGHT MEDIUM BROAD SPECTRUM SPF 15 JAFRA- avobenzone, octinoxate, 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 January 28, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients       Purpose

    Avobenzone 2%         Sunscreen

    Octinoxate 5%           Sunscreen

    Octisalate 4%            Sunscreen

    Octocrylene 1.8%       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

    Keep out of reach of children

    Stop use and ask a doctor if rash occurs

    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.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

    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

    Sun Protection Measures

    Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk of 15 or higher and other sun protection measures including:

               - limit time in the sun, especially from 10 a.m. - 2p.m.

               - wear long sleeve-shirts, pants, hats, and sunglasses

    Water/Aqua, Phenyl Trimethicone, Cyclomethicone, Hydroxypropylcocoate PEG-8 Dimethicone, Triethoxycaprylylsilane, Cyclopentasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Phenyl Dimethicone, Squalane, Trihydroxystearin, Magnesium Aluminum Silicate, Silica, aluminum Starch Octenylsuccinate, Lauryl Lysine, Polysorbate 20, Lecithin, Polymethyl Methacrylate, Caprylyl Glycol, Ethylhexylglycerin, Undecylenoyl Glycine, Hexylene Glycol, Methylisothiazolinone, Xanthan Gum, Sodium Chloride, Cucumis Sativus Extract , Glycyrrhiza Glabra Extract  [May contain/+/-:  Iron Oxides/CI 77491/CI 77492/77499, Titanium Dioxide/CI 77891]

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    CC CREAM COMPLEXION CORRECTOR LIGHT MEDIUM BROAD SPECTRUM SPF 15  JAFRA
    avobenzone, octinoxate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-190
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    SQUALANE (UNII: GW89575KF9)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    UNDECYLENOYL GLYCINE (UNII: 4D20464K2J)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CUCUMBER (UNII: YY7C30VXJT)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    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:68828-190-021 in 1 CARTON03/03/2014
    1NDC:68828-190-0130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/03/2014
    Labeler - Jafra cosmetics International (041676479)
    Registrant - Jafra Cosmetics International (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-190)