Label: JAFRA FRUTERIA COCO FRESCO LIP BALM- dimethicone gel

  • NDC Code(s): 68828-010-01
  • Packager: Jafra Cosmetics International, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 April 12, 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, Flavor/Aroma, Silica Dimethyl Silylate, Oleic / Linoleic / Linolenic Polyglycerides, Dimethicone, Pouteria Sapota Seed Oil, Tocopheryl Acetate, Benzyl Alcohol, Limonene.

  • SPL UNCLASSIFIED SECTION

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    JAFRA FRUTERIA COCO FRESCO LIP BALM 
    dimethicone gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-010
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-010-011 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 finalpart34706/01/2023
    Labeler - Jafra Cosmetics International, Inc. (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Distribuidora Comercial Jafra, S.A. de C.V.951612777manufacture(68828-010)
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