Label: URSA MAJOR FORCE FIELD SPF 30- zinc oxide cream

  • NDC Code(s): 83456-000-00
  • Packager: Ursa Major Natural Care, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 28, 2023

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  • Drug Facts

  • Active Ingredients

    Non-Nano Uncoated Zinc Oxide 14.95%

    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.

  • 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.

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally and evenly 15 minutes before sun exposure. • Reapply at least every 2 hours. • Use a water-resistant sunscreen if swimming or sweating. • 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 10am-2pm; wear long-sleeved shirts, pants, hats and sunglasses. • Children under 6 months of age: Ask a doctor.



    Sun Protection Measures:

  • INACTIVE INGREDIENTS:

    Water (Aqua), Coco-Caprylate/Caprate, Cetearyl Alcohol, Dicaprylyl Carbonate, Glycerin, Methyl Dihydroabietate, Coco-Glucoside, Propanediol, Vaccinium Vitis-Idaea Fruit Extract, Pongamia Pinnata Seed Extract, Squalane, Butyrospermum Parkii Butter, Theobroma Grandiflorum Seed Butter, Rubus Idaeus Seed Oil, Daucus Carota Sativa Seed Oil, Inula Helenium Extract, Lecithin, Rhododendron Ferrugineum Leaf Cell Culture Extract, Glyceryl Caprylate, Polyglyceryl-3 Polyricinoleate, Diheptyl Succinate, Isomalt, Isostearic Acid, Citric Acid, Caprylhydroxamic Acid, Phytic Acid, Benzyl Alcohol, Capryloyl Glycerin/Sebacic Acid Copolymer, Xanthan Gum, Gluconolactone, Sodium Hyaluronate, Tocopherol, Calcium Gluconate, Sodium Benzoate, Benzoic Acid.

  • Other Information

    Protect the product in this container from excessive heat and direct sun.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    URSA MAJOR FORCE FIELD SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83456-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION149.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    LINGONBERRY (UNII: 0UNK9RZQ7X)  
    PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)  
    SQUALANE (UNII: GW89575KF9)  
    THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)  
    CARROT SEED OIL (UNII: 595AO13F11)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
    ISOMALT (UNII: S870P55O2W)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    FYTIC ACID (UNII: 7IGF0S7R8I)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83456-000-001 in 1 CARTON05/01/2023
    150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/01/2023
    Labeler - Ursa Major Natural Care, LLC (013457261)