Label: ARUBA ALOE SPORT LINE LIP BALM BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide stick

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

Drug Label Information

Updated November 6, 2023

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  • Drug Facts

  • Active ingredients

    Titanium Dioxide 10% Zinc Oxide 10%

    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.

    f 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 Cacao (Cocoa) Seed Butter, Cera Alba (Beeswax), Euphorbia Cerifera (Candelilla) Wax, Cocos Nuceifera (coconut) Oil, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Tocopheryl Acetate (Vitamin E Acetate), Sorbitan Oleate.

  • Package Labeling:

    Tube

  • INGREDIENTS AND APPEARANCE
    ARUBA ALOE SPORT LINE LIP BALM BROAD SPECTRUM SPF 30 
    titanium dioxide, zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53675-187
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE50 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION80 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    COCOA (UNII: D9108TZ9KG)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53675-187-004.8 g in 1 TUBE; Type 0: Not a Combination Product05/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/15/2020
    Labeler - Aruba Aloe Balm NV (855442273)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aruba Aloe Balm NV855442273manufacture(53675-187)
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