Label: ALOE UP NATURAL LIP ICE SUNSCREEN- octinoxate, oxybenzone lipstick

  • NDC Code(s): 61477-214-14
  • 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 INGREDIENT

    ACTIVE INGREDIENTS:

    OCTINOXATE (%)

    OXYBENZONE (4.5%)

  • PURPOSE

    PURPOSE:

    SUNSCREEN

  • INDICATIONS & USAGE

    INDICATIONS:

    HELPS PREVENT SUNBURN.

  • DOSAGE & ADMINISTRATION

    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.

  • WARNINGS

    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.

  • INACTIVE INGREDIENT

    Other Ingredients:

    ALOE BARBADENSIS LEAF JUICE, BEESWAX, BHT, CAPRYLIC/CAPRIC TRIGLYCERIDE, COCOS NUCIFERA (COCONUT) OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HYDROGENATED VEGETABLE OIL, LANOLIN, MANGIFERA INDICA (MANGO) SEED BUTTER, PERSEA GRATISSIMA (AVOCADO) OIL, RICINUS COMMUNIS (CASTOR) SEED OIL, TOCOPHEROL, TOCOPHERYL ACETATE (VITAMIN E)

  • PRINCIPAL DISPLAY PANEL

    Aloe Up White Line SPF 15 Natural Lip Balm

  • INGREDIENTS AND APPEARANCE
    ALOE UP NATURAL LIP ICE SUNSCREEN 
    octinoxate, oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61477-214
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61477-214-144.25 g in 1 TUBE; Type 0: Not a Combination Product02/24/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/24/2014
    Labeler - Aloe Care International, LLC (938242187)
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