Label: ALBA BOTANICA SENSITIVE MINERAL SUNSCREEN SPF 33- zinc oxide aerosol

  • NDC Code(s): 61995-3033-1, 61995-3033-2, 61995-3033-3
  • Packager: The Hain Celestial Group, Inc.
  • 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 August 11, 2023

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  • ACTIVE INGREDIENT

    Zinc Oxide 18.3% (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

    Aloe Barbadensis Leaf Juice, Bentonite, Bisabolol, Butyloctyl Salicylate, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Cellulose Gum, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Coco-Glucoside, Ethyl Macadamiate, Ginkgo Biloba Leaf Extract, Glycerin, Glyceryl Caprylate, Helianthus Annuus (Sunflower) Seed Oil, Jojoba Esters, Methyl Dihydroabietate, Microcrystalline Cellulose, Propanediol, Shea Butter Ethyl Esters, Sodium Gluconate, Tocopherol, Water (Aqua)

  • 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 SENSITIVE MINERAL SUNSCREEN SPF 33 
    zinc oxide aerosol
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-3033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE18.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    .BETA.-BISABOLOL (UNII: LP618AV2EA)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENTONITE (UNII: A3N5ZCN45C)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    PEG-4 CAPRYLIC/CAPRIC GLYCERIDES (UNII: H45189YI2Q)  
    GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-3033-1148 g in 1 CAN; Type 0: Not a Combination Product01/01/2022
    2NDC:61995-3033-2177 g in 1 CAN; Type 0: Not a Combination Product01/01/2022
    3NDC:61995-3033-3237 g in 1 CAN; Type 0: Not a Combination Product01/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2022
    Labeler - The Hain Celestial Group, Inc. (117115556)
    Registrant - The Hain Celestial Group, Inc. (081512382)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.081512382manufacture(61995-3033)
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