Label: MINI PEACH LIP BALM- shea butter cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated June 30, 2016

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  • ACTIVE INGREDIENT

    Active ingredient: Shea Butter 15.0%

  • INACTIVE INGREDIENT

    Inactive Ingredient: Petrolatum, Diisostearyl Malate, Carthamus Tinctorius (Safflower) Seed Oil, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Beeswax, Ceresin, Fragrance, Sorbitan Sesquioleate, Copernicia Cerifera (Carnauba) Wax, Paraffin, Tocopheryl Acetate, Polyglyceryl-2 Triisostearate, Water, Sodium Hyaluronate, Ceramide 3, Rosa Canina Fruit Oil, Butylene Glycol, Lanolin wax, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Alcohol, Prunus Persica (Peach) Fruit Extract, Hamamelis Virginiana (Witch Hazel) Extract, CI 19140:1, CI 15850, Butylparaben, Phenoxyethanol

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: For external use only When using this product do not get into eyes Stop use and ask a doctor if rash occurs Do not use on - deep puncture wounds - animal bites - serious burns Keep out of reach of children

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Use

    Use: Helps prevent and relieve chapped or cracked skin

  • Directions

    Directions: - Clean the skin thoroughly before using - Apply in daily skin care routine

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    MINI PEACH LIP BALM 
    shea butter cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-315
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Shea Butter (UNII: K49155WL9Y) (Shea Butter - UNII:K49155WL9Y) Shea Butter1.05 g  in 7 g
    Inactive Ingredients
    Ingredient NameStrength
    Petrolatum (UNII: 4T6H12BN9U)  
    Diisostearyl Malate (UNII: QBS8A3XZGQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59078-315-021 in 1 CARTON05/01/2016
    1NDC:59078-315-017 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2016
    Labeler - TONYMOLY CO.,LTD (688216798)
    Registrant - TONYMOLY CO.,LTD (688216798)
    Establishment
    NameAddressID/FEIBusiness Operations
    TONYMOLY CO.,LTD688216798manufacture(59078-315)
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