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
  • 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 June 7, 2023

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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
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 mL
    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
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    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 not finalpart35202/24/2014
    Labeler - Aloe Care International, LLC (938242187)
    Registrant - Aloe Care International, LLC (938242187)
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