Label: ALBA BOTANICA SPORT SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene spray

  • NDC Code(s): 61995-0388-1, 61995-0388-2, 61995-0388-3
  • Packager: Hain Celestial Group, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 16, 2023

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

  • ACTIVE INGREDIENT

    Avobenzone 2.9%

    Homosalate 14.7%

    Octisalate 4.9%

    Octocrylene 7.6%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    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.

  • DOSAGE & ADMINISTRATION

    Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. Children under 6 months: ask a doctor. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF 15 or higher and other protective measures including:

    • limit time in the sun, especially from 10am to 2pm
    • and wear long-sleeved shirts, pants, hats and sunglasses.

  • WARNINGS

    For external use only. Do not use on broken or damaged skin. When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs. If swallowed, get medical help or contact a Poison Control Center right away.

  • 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.

  • INACTIVE INGREDIENT

    Alcohol Denat., Butyloctyl Salicylate, Acrylates/Octylacrylamide Copolymer, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract, Carthamus Tinctorius (Safflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Diisopropyl Adipate, Ginkgo Biloba Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, Panax Quinquefolius Root Extract, Persea Gratissima (Avocado) Oil, Tocopheryl Acetate.

  • PRINCIPAL DISPLAY PANEL

    Sport

  • INGREDIENTS AND APPEARANCE
    ALBA BOTANICA SPORT SPF 50 SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-0388
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.6 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.9 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.9 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE14.7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    AMERICAN GINSENG (UNII: 8W75VCV53Q)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALCOHOL (UNII: 3K9958V90M)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CHAMOMILE (UNII: FGL3685T2X)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    GINKGO (UNII: 19FUJ2C58T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-0388-1148 mL in 1 CAN; Type 0: Not a Combination Product10/01/2022
    2NDC:61995-0388-2177 mL in 1 CAN; Type 0: Not a Combination Product10/01/2022
    3NDC:61995-0388-3237 mL in 1 CAN; Type 0: Not a Combination Product10/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/01/2022
    Labeler - Hain Celestial Group, Inc. (117115556)