Label: MINERAL SPF 15 BROAD SPECTRUM LIP BALM stick

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

Drug Label Information

Updated October 18, 2023

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  • Active Ingredients

    Avobenzone 2.0%

    Octinoxate 6.5%

    Octisalate 5.0%

    Octocrylene 1.5%

  • Purpose

    Sunscreen

  • Warnings

    For external use only

  • Do not use

    on damaged or broken skin.

  • Stop Use and ask a doctor if

    Rash Occurs

  • When Using this Product

    Keep out of eyes. Rinse well 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.

  • Directions

    Apply liberally 15 minutes before sun exposure

    Use a water resistant sunscreen if swimming or sweating

    Reapply at least every 2 hours
    Children under 6 months of age: Ask a doctor

  • Inactive ingredients:

    Sunflower Oil*, Beeswax, Olive Oil*, Tocopherol, Aloe Extract, Canola Oil, Soybean Oil. * Organic

  • DOSAGE & ADMINISTRATION

    Apply liberally 15 minutes before sun exposure

  • INDICATIONS & USAGE

    Helps prevent sunburn

  • Package Label

    C10873 SPF 15 UNFLAVORED MINERAL LIP BALM

  • INGREDIENTS AND APPEARANCE
    MINERAL SPF 15 BROAD SPECTRUM LIP BALM 
    mineral spf 15 broad spectrum lip balm stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-0515
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.34 g  in 4.25 g
    Inactive Ingredients
    Ingredient NameStrength
    CANOLA OIL (UNII: 331KBJ17RK)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65692-0515-14.25 g in 1 TUBE; Type 0: Not a Combination Product02/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/17/2020
    Labeler - Raining Rose, Inc (083819404)
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