Label: JAFRA FRUTERIA VERY VERDE LIP BALM- dimethicone gel

  • NDC Code(s): 68828-012-01
  • Packager: Jafra Cosmetics International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 26, 2023

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  • Active Ingredient

    Dimethicone 1%

  • Purpose

    Skin protectant

  • Uses

    • Helps prevent and temporarily protects and helps relieve chapped or cracked lips
    • Helps prevent and protect from the drying effects of wind and cold weather
  • Warnings

    For external use only
    When using this product● do not get into eyes
    Stop use and ask a doctor if● condition worsens ● symptoms last more than 7 days or clear up and occur again in a few days
    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 as needed

  • Inactive Ingredients

    Polybutene, Bis-Diglyceryl Polyacyladipate-2, Sesamum Indicum (Sesame) Seed Oil, Butyrospermum Parkii (Shea) Butter, Prunus Armeniaca (Apricot) Kernel Oil, Ozokerite, Garcinia Indica Seed Butter, Persea Gratissima (Avocado) Oil, Silica Dimethyl Silylate, Oleic / Linoleic / Linolenic Polyglycerides, Pouteria Sapota Seed Oil, Tocopheryl Acetate, Fragrance/Parfum, Benzyl Alcohol, Benzyl Benzoate, Limonene.

  • Product label

    image description
  • INGREDIENTS AND APPEARANCE
    JAFRA FRUTERIA VERY VERDE LIP BALM 
    dimethicone gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    SESAME OIL (UNII: QX10HYY4QV)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    CERESIN (UNII: Q1LS2UJO3A)  
    GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-012-011 in 1 CARTON06/01/2023
    115 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01606/01/2023
    Labeler - Jafra Cosmetics International, Inc. (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Distribuidora Comercial Jafra, S.A. de C.V.951612777manufacture(68828-012)
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