Label: GZE LIP BALM- sunflower seed oil,shea butter paste

  • NDC Code(s): 83566-282-01
  • Packager: Guangzhou Yilong Cosmetics Co.,Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 29, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Helianthus Annuus (Sunflower) Seed Oil,Butyrospermum Parkii (Shea) Butter

  • INACTIVE INGREDIENT

    Cera Alba, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol.

  • PURPOSE

    Lip care.

  • INDICATIONS & USAGE

    Apply generously and evenly to lips 30 minutes before going out in the sun, or whenever they feel dry or chapped.

  • WARNINGS

    For external use only.

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • DO NOT USE

    Do not use on damaged or broken skin.

  • WHEN USING

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Apply generously and evenly to lips 30 minutes before going out in the sun, or whenever they feel dry or chapped.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    GZE LIP BALM 
    sunflower seed oil,shea butter paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83566-282
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SUNFLOWER SEED (UNII: R9N3379M4Z) (SUNFLOWER SEED - UNII:R9N3379M4Z) SUNFLOWER SEED45 g  in 100 g
    SHEA BUTTER (UNII: K49155WL9Y) (SHEA BUTTER - UNII:K49155WL9Y) SHEA BUTTER15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PEG-8 BEESWAX (UNII: 3C1QUF1TIR)  
    SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83566-282-017 g in 1 TUBE; Type 0: Not a Combination Product07/19/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)07/19/2024
    Labeler - Guangzhou Yilong Cosmetics Co.,Ltd. (712647107)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Yilong Cosmetics Co., Ltd712647107manufacture(83566-282)