Label: ALOE UP PRO SPF 50 ADVANCED FORMULA ULTRA SPORT SUNSCREEN- avobenzone, homosalate, octinoxate, octisalate, octocrylene lotion

  • NDC Code(s): 61477-210-14
  • 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:

    AVOBENZONE (3%)

    HOMOSALATE (5%)

    OCTINOXATES (6.0%)

    OCTISALATE (5%)

    OCTOCRYLENE (10%)

  • PURPOSE

    PURPOSE:

    SUNSCREEN

  • INDICATIONS & USAGE

    INDICATIONS:

    HELPS PREVENT SUNBURN

  • DOSAGE & ADMINISTRATION

    DIRECTIONS:

    APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.

    REAPPLY: AFTER 40 MINUTES OF SWIMMING OR SWEATING; IMMEDIATELY AFTER TOWEL DRYING; AT LEAST EVERY 2 HOURS.

  • 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. STOP USE AND ASK A DOCTOR IF RASH OCCURS. KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • INACTIVE INGREDIENT

    Other Ingredients:

    ACRYLATES/C10-30 ALKYL ACRYLATES CROSSPOLYMER, ALLANTOIN, ALOE BARBADENSIS LEAF JUICE, ALUMINUM STARCH OCTENYLSUCCINATE, BUTYLPHTHALIMIDE, C12-15 ALKYL BENZOATE, CAMELLIA SINENSIS LEAF EXTRACT, CARBOMER, IODOPROPYNYL BUTYLCARBAMATE, ISODECYL NEOPENTANOATE, ISOPROPYLPHTHALIMIDE, METHYLISOTHIAZOLINONE, PEG-8 PHENOXYETHANOL, POLYETHYLENE, POLYSORBATE 20, PROPANEDIOL, SORBITOL, THEOBROMA CACAO (COCOA) SEED BUTTER, TOCOPHERYL ACETATE, TRIETHANOLAMINE, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, WATER

  • PRINCIPAL DISPLAY PANEL

    Aloe Up Pro SPF 50 Lotion

  • INGREDIENTS AND APPEARANCE
    ALOE UP PRO SPF 50 ADVANCED FORMULA  ULTRA SPORT SUNSCREEN
    avobenzone, homosalate, octinoxate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61477-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    3-BUTYLPHTHALIDE (UNII: 822Q956KGM)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SORBITOL (UNII: 506T60A25R)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61477-210-14118 mL 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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