Label: SPIT AND POLISH MINERAL LIP BALM BROAD SPECTRUM LIP PROTECTANT SPF 30- zinc oxide stick

  • NDC Code(s): 80325-002-01
  • Packager: Naturally Uncommon, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 9, 2023

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  • DRUG FACTS

  • Active Ingredients

    Zinc Oxide 8%

    Purpose

    Sunscreen

    Uses

    • Helps prevent sunburn. 
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Warnings:

    For external use only.

    Do not use

    • on damaged or broken skin.
    • If rash occurs,

    stop use and consult a doctor.

    Keep out of reach of children.

    • If product is swallowed, get medical help or contact a Poison Control Center right away.
  • Directions:

    • Apply liberally 15 minutes before sun exposure.
    • Reapply:
    • After 80 minutes of swimming or sweating.
    • Immediately after towel drying.
    • At least every 2 hours.

    Sun protection measures

    Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures.

  • INACTIVE INGREDIENTS:

    Prunus Amygdalus Dulcis (Almond) Oil, Butyrospermum Parkii (Shea) Butter, Cera Alba (Beeswax), Simmondsia Chinensis (Jojoba) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, DL-Alpha-Tocopheryl Acetate, Argania Spinosa Kernel (Argan) Oil, Copernicia Cerifera (Carnauba) Wax, Bisabolol, Glyceryl Caprylate, Glyceryl Undecylenate, Triethoxycaprylylsilane

  • Package Labeling:

    Bottle4

  • INGREDIENTS AND APPEARANCE
    SPIT AND POLISH MINERAL LIP BALM BROAD SPECTRUM LIP PROTECTANT SPF 30 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80325-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION80 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALMOND (UNII: 3Z252A2K9G)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80325-002-014.25 g in 1 APPLICATOR; Type 0: Not a Combination Product03/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/01/2020
    Labeler - Naturally Uncommon, LLC (044473410)
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