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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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, 2021

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  • 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

    Keep out of reach of children. If amount greater than normal use is swallowed get medical attention or call Poison Control Center immediately.

  • DIRECTIONS

    Apply liberally and as needed.

  • OTHER INFORMATION

    Protect this product from excessive heat and direct sun.

  • INACTIVE INGREDIENT

    Helianthus Annuus (Sunflower) Seed Oil*, Beeswax*, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil*, Natural Flavor, Polyhydrostearic Acid, Butyrospermum Parkii (Shea) 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)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    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 finalpart35205/21/2019
    Labeler - TUBBY TODD (052545299)
    Establishment
    NameAddressID/FEIBusiness Operations
    Private Label Select Ltd CO005415463manufacture(73088-105)
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