Label: DEFY TIME PROTECTOR MOISTURIZER BROAD SPECTRUM SPF 15 JAFRA TIME DYNAMICS- 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 May 21, 2019

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  • ACTIVE INGREDIENT

    Active Ingredients                     Purpose

    Octinoxate  7.5%                         Sunscreen

    Zinc Oxide  3%                            Sunscreen

  • PURPOSE

    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

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Contol 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

    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 of SPF 15 or higher and other sun protection measures including:

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

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

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water/Aqua, Tridecyl Neopentanoate, Polyglyceryl-3 Methylglucose Distearate, Glyceryl Stearate, Dimethicone, Glycerin, Triticum Vulgare (Wheat) Germ Protein, Avena Sativa (Oat) Kernel Protein,Saccharide lsomerate, Polyacrylamide, C13-141soparaffin, Laureth-7, Panthenol, DMDM Hydantoin, Diazolidinyl Urea, Biosaccharide Gum-4, Lecithin,Tocopheryl Acetate, Caprylic/Capric Triglylceride, Ubiquinone, Diisopropyl Adipate, Alcohol, Chondrus Crispus (Carrageenan) Extract, Chlorella Vulgaris Extract, Phytosterol lsostearate, Allantoin, Retinyl Palmitate, Ascorbyl Methylsilanol Pectinate, Trisodium EDTA, PEG-4 Laurate, lodopropynyl Bulylcarbamate, Propylene Glycol, Camellia Sinensis Leal Extract, Glycine Soja (Soybean) Seed Extract, Ceramide 3, Smithsonite Extract

  • PRINCIPAL DISPLAY PANEL

    Jafra

    time dynamics defy

    Time protector Moisturizer broad spectrum SPF 15

    50ml 1.7fl oz

    carton

  • INGREDIENTS AND APPEARANCE
    DEFY TIME PROTECTOR MOISTURIZER BROAD SPECTRUM SPF 15  JAFRA TIME DYNAMICS
    octinoxate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WHEAT GERM (UNII: YR3G369F5A)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    ALCOHOL (UNII: 3K9958V90M)  
    CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    ALLANTOIN (UNII: 344S277G0Z)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBYL METHYLSILANOL PECTINATE (UNII: M3PF9237YC)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-201-021 in 1 CARTON11/25/2014
    1NDC:68828-201-0150 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/25/2014
    Labeler - Jafra Cosmetics International (041676479)
    Registrant - Jafra Cosmetics International (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jafra Manufacturing S.A. de C.V.814732061manufacture(68828-201)
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