Label: ALBA SUNSCREEN LIP BALM SPF 25- zinc oxide, octocrylene, octisalate stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2023

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    Zinc Oxide 10%

    Octocrylene 10%

    Octisalate 5%

  • INDICATIONS & USAGE

                                 USES

    •     Helps prevent sunburns
    •     Higher SPF gives more sunburn protection
    •     Apply liberally as needed 15 to 20 minutes before sun exposure
    •      Reapply as needed or after swimming, perspiring or towel drying
    •      Children under 6 months of age: ask doctor
  • WARNINGS

    For external use only. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact Poison Center right away.

  • QUESTIONS

    QUESTIONS?

    Call (888) 659-7730 or visit www.AlbaBotanica.com

    Made in the U.S.A.

  • INACTIVE INGREDIENT

    Olea Europaea (Olive) Fruit Oil (1), Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil (1), Euphorbia Cerifera (Candelilla) Wax, Theobroma Cacao (Cocoa) Seed Butter (1), Jojoba Esters, Jojoba Esters/Helianthus Annuus (Sunflower) Seed Wax/Acacia Decurrens Flower Wax/Polyglycerin-3, Flavor, Glycerin (1), Copernicia Cerifera (Carnauba) Wax, Butyrospermum Parkii (Shea) Butter (1), Helianthus Annuus (Sunflower) Seed Oil, Aloe Barbadensis Leaf Juice (1), Chamomilla Recutita (Matricaria) Flower Extract, Echinacea Angustifolia Leaf Extract (1), Hydrastis Canadensis (Goldenseal) Root Extract (1), Glycyrrhiza Glabra (Licorice) Root Extract (1), Symphytum Officinale Leaf Extract (1), Tocopherol

    (1)Certified Organic Ingredient

  • DOSAGE & ADMINISTRATION

    Sunscreen Lip Balm

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • PURPOSE

    Sunscreen

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    ALBA SUNSCREEN LIP BALM SPF 25 
    zinc oxide, octocrylene, octisalate stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-3037
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)  
    ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    ECHINACEA ANGUSTIFOLIA LEAF (UNII: FS7G8S6PJ8)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYDROGENATED OLIVE OIL (UNII: 53839415GI)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SUNFLOWER SEED OIL GLYCERETH-8 ESTERS (UNII: 358X17CAT0)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    GLYCYRRHIZA GLABRA WHOLE (UNII: M1F96IE0ZC)  
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
    SUNFLOWER SEED (UNII: R9N3379M4Z)  
    HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-3037-11 in 1 CARTON10/10/2022
    14.2 g in 1 CANISTER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02110/27/2009
    Labeler - The Hain Celestial Group, Inc. (117115556)
    Registrant - The Hain Celestial Group, Inc. (014334364)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.081512382manufacture(61995-3037)
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