Label: ARUBA ALOE LIP SUNSCREEN AND MOISTURIZER- oxybenzone, padimate lipstick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 7, 2018

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  • Active Ingredients

    Oxybenzone 3.0% and Padimate O 8.0%

  • Use

    Helps prevent sunburn

  • Warnings

    Stop use if skin rash occurs

  • Inactive Ingredients

    Petrolatum, Cocoa Butter, Canderila Wax, Beeswax, Coconut Oil, Aruba Aloe Vera Gel, Tocopheryl Acetate (Vitamin E Acetate).

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED IN THE U.S.A. BY ARUBA ALOE OF  NORTH AMERICA, LLC, INDIANAPOLIS, IN 46244

    MADE IN ARUBA

    TO REPORT A SERIOUS ADVERSE EVENT CONTACT 1-800-95-ARUBA

    www.ArubaAloe.com

  • PRINCIPAL DISPLAY PANEL

    Lip Sunscreen and Moisturizer

  • INGREDIENTS AND APPEARANCE
    ARUBA ALOE LIP SUNSCREEN AND MOISTURIZER 
    oxybenzone, padimate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53675-140
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 g
    PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ACETATE ION (UNII: 569DQM74SC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53675-140-014.8 g in 1 TUBE; Type 0: Not a Combination Product06/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2011
    Labeler - Aruba Aloe Balm NV (855442273)
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