Label: TIME DYNAMICS TIME PROTECTOR DAILY DEFENSE SPF 15- octinoxate, zinc oxide cream, augmented

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 June 13, 2012

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  • ACTIVE INGREDIENT


    Sunscreen Active Ingredients (SPF 15): Octinoxate/Ethylhexyl Methoxycinnamate, Zinc Oxide

    Purpose: Sunscreen

    Keep out of reach of children

    Discontinue use if signs of irritation occur.

    Cautions: For external use only. Avoid contact with eyes.


    To use: In the morning after cleansing. Smooth over face and throat. Clinically, allergy, irritancy tested.

    Other ingredients: Water/Aqua, Gelatin, Retinyl Palmitate, Tridecyl Neopentanoate, Polyglyceryl-3 Methylglucose Distearate, Dimethicone, Glyceryl Stearate, Glycerin, Polacrylamide, C13-14 Isoparaffin, Laureth-7, Triticum Vulgare (wheat) Germ Protein, Avena Sativa (Oat) Kernel Protein, Saccharide Isomerate, Glycine Soja (Soybean) Seed Extract, Ceramide 3, Propylene Glycol, Camellia Sinensis Leaf Extract, Panthenol, Ubiquinone, Chondrus Crispus (Carrageenan) Extract, Biosaccharide Gum-4, Chlorella Vulgaris Extract, Phytosterol Isostearate, Allantoin, Ascorbyl Methylsilanol Pectinate, Tocopheryl Acetate, Lecithin, Caprylic/Capric Triglyceride, Diisopropyl Adipate, Trisodium EDTA, Diazolidinyl Urea, Methylparaben, Propylparaben.

  • PRINCIPAL DISPLAY PANEL


    Jafra
    Time Dynamics

    Time protector Daily Defense Cream SPF 15
    Crema  Facial Hidratante De Dia Con *FPS 15
     
    with/con intellishield

    50 ml 1.7 Fl Oz






    image of carton art

  • INGREDIENTS AND APPEARANCE
    TIME DYNAMICS  TIME PROTECTOR DAILY DEFENSE SPF 15
    octinoxate, zinc oxide cream, augmented
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-098
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 mL  in 50 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.5 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GELATIN (UNII: 2G86QN327L)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    WHEAT GERM (UNII: YR3G369F5A)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL METHYLSILANOL PECTINATE (UNII: M3PF9237YC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-098-011 in 1 CARTON
    150 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/30/2012
    Labeler - Jafra Cosmetics International Inc (041676479)
    Registrant - Jafra Cosmetics International Inc (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jafra Manufacturing, S.A. de C.V.814732061manufacture
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