Label: MINERAL LIP BALM SPF-15- zinc oxide lipstick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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  • Drug Facts

  • Active ingredients

    Zinc Oxide 10.5%

  • Purpose

    Sunscreen

  • Uses

    Helps protect against sunburn and chapped lips.

  • Warnings

    Stop use and ask a doctor if rash occurs

    Keep out of reach of children.

    If amount greater than normal use is swallowed get medical attention or call Poison Control Center immediately.

    • Stop use and ask a doctor

    if rash occurs

    • Stop use and ask a doctor

    if rash occurs

  • Directions

    Apply liberally and as needed.

  • Other information

    Protect this product from excessive heat and direct sun.

  • Inactive ingredients

    Helianthus Annuus (Sunflower) Seed Oil*, Beeswax*, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil*, Natural Flavor*, Polyhydroxystearic Acid, Butyrospermum Parkii (Shea) Butter*, Rubus Idaeus (Raspberry) Seed Oil, Theobroma Cacao (Cocoa) Butter*, Tocopherol, Simmondsia Chinensis (Jojoba) Seed Oil*, Calophyllum Inophyllum (Tamanu) Seed Oil*
    *Certified organic ingredient(s)

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Lip Balm_SPF15_Key Lime

    01b LBL_Mineral Lip Balm SPF-15_Pina Colada

  • INGREDIENTS AND APPEARANCE
    MINERAL LIP BALM  SPF-15
    zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73088-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TAMANU OIL (UNII: JT3LVK84A1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73088-105-114.2 g in 1 TUBE; Type 0: Not a Combination Product05/21/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/21/2019
    Labeler - TUBBY TODD (052545299)
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