Label: TIME DYNAMICS DEFY TIME PROTECTOR MOISTURIZER BROAD SPECTRUM SPF 15- octinoxate, zinc oxide cream

  • NDC Code(s): 68828-750-01, 68828-750-02
  • Packager: Jafra Cosmetics International
  • 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 July 25, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients 

    Octinoxate  7.5%

    Zinc Oxide  3%

  • Purpose

    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.

  • Warnings

    For external use only

    Do not useon damaged or broken skin

    When using this productkeep out of eyes. Rinse with water to remove.

    Stop use and ask a doctorif rash occurs

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

  • 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 value 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 Ingredients

    Alcohol, Allantoin, Ascorbyl Methylsilanol Pectinate, Avena Sativa (Oat) Kernel Extract, Biosaccharide Gum-4, C13-14 Isoparaffin, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglylceride, Ceramide 3, Chlorella Vulgaris Extract, Chondrus Crispus (Carrageenan) Extract, Diazolidinyl Urea, Diisopropyl Adipate, DMDM Hydantoin, Glycerin, Triticum Vulgare (Wheat) Germ Protein, Glyceryl Stearate, Glycine Soja (Soybean) Seed Extract, Iodopropynyl Bulylcarbamate, Laureth-7, Lecithin, Panthenol, PEG-4 Laurate, Phytosterol Isostearate, Polyacrylamide, Polyglyceryl-3 Methylglucose Distearate, Propylene Glycol, Retinyl Palmitate, Saccharide Isomerate, Smithsonite Extract, Tocopheryl Acetate, Tridecyl Neopentanoate, Triethoxycaprylylsilane, Trisodium EDTA, Ubiquinone, Water/Aqua

  • Other information

    Protect this product from excessive heat and direct sun

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    TIME DYNAMICS DEFY TIME PROTECTOR MOISTURIZER BROAD SPECTRUM SPF 15 
    octinoxate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-750
    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
    ALCOHOL (UNII: 3K9958V90M)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL METHYLSILANOL PECTINATE (UNII: M3PF9237YC)  
    OAT (UNII: Z6J799EAJK)  
    BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WHEAT GERM (UNII: YR3G369F5A)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    LAURETH-7 (UNII: Z95S6G8201)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-750-021 in 1 CARTON01/11/202203/01/2022
    1NDC:68828-750-0150 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/11/2022
    Labeler - Jafra Cosmetics International (041676479)
    Registrant - Jafra Cosmetics International (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Distribuidora Comercial Jafra, S.A. de C.V.951612777manufacture(68828-750)
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