Label: SPIT AND POLISH SUN SMART SUNSCREEN- titanium dioxide, zinc oxide lotion

  • NDC Code(s): 80325-001-01
  • Packager: Naturally Uncommon, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 9, 2023

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

  • DRUG FACTS

  • Active Ingredients

    Titanium Dioxide 7% and Zinc Oxide 10%

    Purpose

    Sunscreen

  • Uses:

    Helps prevent sunburn. If used as directed with other sun protection measures decreases the risk of skin cancer and early aging caused by the sun.

  • Warning:

    For external use only.

    Do not use

    on damaged or broken skin.

    When using this product

    avoid contact with eyes, contact with eyes occurs, flush with water to remove.

    Stop use and ask a doctor

    If irritation or rash develops or persists.

    Keep out of reach of children.

    If swallowed, seek immediate medical attention of contact a Poison Control Center right away.

  • Directions:

    Apply liberally and evenly 15 minutes prior to sun exposure. Reapply after 80 minutes of swimming or sweating Reapply after towel drying. Reapply at least every 2 hours.

    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 including limiting time in the sun. especially between 10 a.m. and 2 pm, and wear long-sleeved shirts, pants, hats and sunglasses. Sun protection measures:

    : Consult a physician. For use on children under 6

  • Other information:

    Protect this product from excessive heat or direct sun.

  • INACTIVE INGREDIENTS:

    ALOE BARBADENSIS LEAF GEL,BUTYLOCTYL SALICYLATE, CAPRYLIC/ CAPRIC/ MYRISTIC/STEARIC TRIGLYCERIDES, CAPRYLIC/CAPRIC/TRIGLYCERIDE (AND) STEARALKONIUM HECTORITE (AND) PROPYLENE CARBONATE, CERA ALBA, DAUCUS CAROTA SATIVA (CARROT) EXTRACT, GLYCERIN (AND) CAMELLIA SINENSIS LEAF EXTRACT, HYDROGENATED COCO-GLYCERIDES, GLYCRRHIZA GLABRA (LICORICE) ROOT EXTRACT, LEUCONO STOC/RADISH ROOT FERMENT FILTRATE, MAGNESIUM SULFATE. POLYGLYCERYL 3 POLYRICINOLEATE, POLY- HYDROXYSTEARIC ACID, SORBITAN OLEATE, WATER.

  • Package Labeling:

    Label2Label

  • INGREDIENTS AND APPEARANCE
    SPIT AND POLISH SUN SMART SUNSCREEN 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80325-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE70 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERYL TRISTEARATE (UNII: P6OCJ2551R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CARROT (UNII: L56Z1JK48B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80325-001-01177 mL in 1 TUBE; 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)