Label: ALOE KOTE SPF 25- octinoxate, oxybenzone, homosalate cream

  • NDC Code(s): 61477-225-11
  • Packager: Aloe Care International, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 13, 2024

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  • ACTIVE INGREDIENTS:

    OCTINOXATE (7.4%)

    OXYBENZONE (5.9%)

    HOMOSALATE (14.5%)

  • PURPOSE:

    SUNSCREEN

  • USES

    HELPS PREVENT SUNBURN.

  • 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: ASK A DOCTOR.
  • 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.

  • WARNINGS:

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. 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 with water to remove.

  • INACTIVE INGREDIENTS

    Aloe Oil Extract, Ganex V-220, Ozokerite Wax #871, Protopet Alba USP

  • OTHER INFORMATION

    • Protect this product from excessive heat and direct sun

  • Questions or comments?

    Toll Free 800-950-2563

    www.aloeup.com

  • PRINCIPAL DISPLAY PANEL

    LBL_Aloe Kote SPF-25

  • INGREDIENTS AND APPEARANCE
    ALOE KOTE  SPF 25
    octinoxate, oxybenzone, homosalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61477-225
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.4 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE14.5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5.9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61477-225-117 g in 1 JAR; Type 0: Not a Combination Product05/17/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/17/2019
    Labeler - Aloe Care International, LLC (938242187)
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