Label: MINERAL SUNSCREEN LIP BALM SPF 15- titanium dioxide, zinc oxide lipstick

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

Drug Label Information

Updated November 6, 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.

    When using this product

    keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if

    rash occurs.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply generously 15 minutes before sun exposure.
    • reapply
    • after 80 minutes of swimming or sweating.
    • immediately after towel drying.
    • at least every 2 hours.
    • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures.
    • limit time in the sun, especially from 10 a.m.-2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses.
    • children under 6 months of age: Ask a doctor.
  • Other Information

    • protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients

    Petrolatum, Theobroma Cacoa (Cocoa) Seed Butter, Euphorbia Cerifera (Candelilla) Wax, Beeswax, Cocos Nucifera (Coconut) Oil, Sorbitan Oleate, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Tocopheryl Acetate (Vitamin E Acetate).

  • Package Labeling:

    Stick

  • INGREDIENTS AND APPEARANCE
    MINERAL SUNSCREEN LIP BALM SPF 15 
    titanium dioxide, zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53675-184
    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
    PETROLATUM (UNII: 4T6H12BN9U)  
    COCOA (UNII: D9108TZ9KG)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    COCONUT (UNII: 3RT3536DHY)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53675-184-174.8 g in 1 APPLICATOR; Type 0: Not a Combination Product01/05/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/05/2019
    Labeler - Aruba Aloe Balm NV (855442273)
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