Label: ARUBA ALOE BROAD SPECTRUM SPF 15 LIP SUNSCREEN AND MOISTURIZER- avobenzone, homosalate, octocrylene, octisalate stick

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 11, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Drug Facts

  • Active ingredients

    Avobenzone (3%), Homosalate (7.34%), Octocrylene (5%), Octyl Salicylate (5%)

    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. 
    • Sun Protection Measures.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: 
    • 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, Euphorbia Cerifera (Candelilla) Wax, Jojoba Esters, Cocos Nucifera (Coconut) Oil, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Tocopheryl Acetate (Vitamin E Acetate), Sorbitan Oleate.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    ARUBA ALOE BROAD SPECTRUM SPF 15 LIP SUNSCREEN AND MOISTURIZER 
    avobenzone, homosalate, octocrylene, octisalate stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53675-208
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE73.4 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    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:53675-208-004.8 g in 1 PACKAGE; Type 0: Not a Combination Product12/14/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/14/2023
    Labeler - Aruba Aloe Balm NV (855442273)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!