Label: DERMA LIP PLUMPER BALM- hyaluronic acid, palmitoyl tripeptide-38, portulaca pilosa extract lipstick

  • NDC Code(s): 82160-429-01
  • Packager: Pella Pharmaceuticals Co. ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 29, 2021

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  • Forms and presentation

    Balm: Tube of 15 g.

  • Active Ingredints

    Hyaluronic Acid

    Portulaca Pilosa Extract

    Palmitoyl Tripeptide-38

  • Inactive ingredients

    Caprylic / Capric Triglyceride, Pentaerytbrityl Tetraisostearate, Myristyl Myristate, Aqua, Cetyl Ester, Petrolatum, Simmondsia Chinensis Seed Oil, Butyrospermum Parkii Butter, Cera Alba, Benzyl Alcohol, Cetearyl Ethylhexanoate, Sorbitan Isostearate, Aroma and Sucrose Cocoate

  • Purpose

    Lip plumper

  • Properties

    Lip balm has a unique formula that lets the lips look full and moist naturally, and it reduces the cracks.
    Paraben free.

  • Indications

    Lip plumper balm

  • Precaution

    Keep out of reach of children

  • Warnings

    • For external use only
    • Avoid contact with eyes
  • Contraindications

    Hypersensitivity to any of the components.

  • Side effects

    There are no known side effects.

  • Dosage and administration

    Apply directly on lips and around lip contour. Use it twice daily

  • Storage conditions

    Store at a temperature below 30 °C.

  • Primary Package

    Primary Package

  • Secondary Package

    Secondary Package

  • INGREDIENTS AND APPEARANCE
    DERMA LIP PLUMPER BALM 
    hyaluronic acid, palmitoyl tripeptide-38, portulaca pilosa extract lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82160-429
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O) (PALMITOYL LYSYLDIOXYMETHIONYLLYSINE - UNII:T7A529FB8O) PALMITOYL LYSYLDIOXYMETHIONYLLYSINE0.00075 mg  in 15 g
    PORTULACA PILOSA WHOLE (UNII: II29C6E5R3) (PORTULACA PILOSA WHOLE - UNII:II29C6E5R3) PORTULACA PILOSA WHOLE0.03 mg  in 15 g
    HYALURONIC ACID (UNII: S270N0TRQY) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONIC ACID0.15 mg  in 15 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
    SUCROSE COCOATE (UNII: 3H18P0UK73)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82160-429-011 in 1 CARTON12/24/2014
    115 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/24/2014
    Labeler - Pella Pharmaceuticals Co. ltd (562370925)