Label: ALBA BOTANICA SHEER MINERAL SPF30- zinc oxide lotion

  • NDC Code(s): 61995-2033-1, 61995-2033-2, 61995-2033-3
  • Packager: The Hain Celestial Group, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 8, 2024

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

  • ACTIVE INGREDIENT

    Zinc Oxide 25% (w/w)

  • DOSAGE & ADMINISTRATION

    Apply liberally 15 minutes before sun exposure. Reapply: ● after 80 minutes of swimming or sweating ● immediately after towel drying ● at least every 2 hours. Children under 6 months of age: ask a doctor.

  • PURPOSE

    Sunscreen

  • 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 skin rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact Poison Center right away.

  • INACTIVE INGREDIENT

    Water (Aqua), Caprylic/Capric Triglyceride, Ethylhexyl Olivate, Butyloctyl Salicylate, Isoamyl Laurate, Glyceryl Stearate SE, Niacinamide, VP/Hexadecene Copolymer, Triethoxycaprylylsilane, Tocopheryl Acetate, Glycerin, Polyhydroxystearic Acid, Potassium Cetyl Phosphate, Sodium Phytate, Squalane, Xanthan Gum, Alcohol (1), Ethylhexylglycerin, Phenoxyethanol

    (1) Certified Organic Ingredient

  • INDICATIONS & USAGE

    Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    ALBA BOTANICA SHEER MINERAL SPF30 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXASODIUM PHYTATE (UNII: ZBX50UG81V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALCOHOL (UNII: 3K9958V90M)  
    ETHYLHEXYL OLEATE (UNII: R34927QY59)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SQUALANE (UNII: GW89575KF9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-2033-159 g in 1 TUBE; Type 0: Not a Combination Product01/01/2022
    2NDC:61995-2033-289 g in 1 TUBE; Type 0: Not a Combination Product01/01/2022
    3NDC:61995-2033-3113 g in 1 TUBE; Type 0: Not a Combination Product01/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2022
    Labeler - The Hain Celestial Group, Inc. (117115556)
    Registrant - The Hain Celestial Group, Inc. (081512382)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.081512382manufacture(61995-2033)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hain-Celestial Canada, ULC201360821manufacture(61995-2033)