Label: DAILY DEFENSE SPF 15 JAFRA- octinoxate and zinc oxide cream

  • NDC Code(s): 68828-131-01, 68828-131-02
  • Packager: Jafra Cosmetics International Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

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  • ACTIVE INGREDIENT

    Active ingredients purpose

    Octinoxate 7.5% Sunscreen

    Zinc Oxide 3% 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. If product is swallowed, get medical help or contact a Poison Control Center right away.

    Stop use and ask a doctor if rash occurs

    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.

    Directions

    apply lliberally 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. - 2p.m.

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

    Water/Aqua, Gelatin, Retinyl Palmitate, Tridecyl Neopentanoate, Polyglyceryl-3 Methylglucose Distearate, Dimethicone, Glyceryl Stearate, Glycerin, Polyacrylamide, 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, Diazolidnyl Urea, Methylparaben, Propylparaben.

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  • PRINCIPAL DISPLAY PANEL

    back

    front

    Jafra Time Dynamics

    Time Dynamics

    Time Protector Daily Defense Cream

    Broad Spectrum SPF 15 with intellishield

    cont. Net. 50 ml 1.7 Fl Oz (US)

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  • INGREDIENTS AND APPEARANCE
    DAILY DEFENSE SPF 15  JAFRA
    octinoxate, zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-131
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    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)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL METHYLSILANOL PECTINATE (UNII: M3PF9237YC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68828-131-02 1 in 1 CARTON
    1 NDC:68828-131-01 50 mL in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 05/30/2012
    Labeler - Jafra Cosmetics International Inc (041676479)
    Registrant - Jafra Cosmetics International Inc (041676479)
    Establishment
    Name Address ID/FEI Business Operations
    Jafra Manufacturing, S.A. de C.V. 814732061 manufacture(68828-131)
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