Label: ALOE UP PRO SPF 30 ULTRA SPORT SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion

  • NDC Code(s): 61477-208-14
  • Packager: Aloe Care International, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 13, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS

    AVOBENZONE (3.0%)

    HOMOSALATE (10.0%)

    OCTISALATE (5.0%)

    OCTOCRYLENE (3.5%)

  • PURPOSE

    SUNSCREEN

  • USES

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun
  • DIRECTIONS

    • apply liberally 15 minutes before sun exposure
    • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months of age: Ask a doctor

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • 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

  • INACTIVE INGREDIENTS

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Aluminum Starch Octenylsuccinate, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis Leaf Extract, Carbomer, Iodopropynyl Butylcarbamate, Isodecyl Neopentanoate, Isopropylphthalimide, PEG-8, Phenoxyethanol, Polyethylene, Polysorbate 20, Propanediol, Sorbitol,
    Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Trisodium Ethylenediamine Disuccinate, Water

  • OTHER INFORMATION

    • protect this product in this container from excessive heat and direct sun.
  • QUESTIONS AND COMMENTS?

    Call toll free 1-800-950-2563

  • PRINCIPAL DISPLAY PANEL

    SPORT SPF 30

  • INGREDIENTS AND APPEARANCE
    ALOE UP PRO SPF 30  ULTRA SPORT SUNSCREEN
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61477-208
    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) HOMOSALATE10 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3.5 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)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
    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:61477-208-14118 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)