Label: LION POSE GHOST-BUSTER BROAD SPECTRUM SPF 42 SUNSCREEN- zinc oxide lotion

  • NDC Code(s): 83605-001-01, 83605-001-02
  • Packager: Lion Pose Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 17, 2023

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  • Drug Facts

  • Active Ingredients

    Zinc oxide 15%

  • 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.

    When using this product

    keep out of eyes. Rinse with water to remove.

    Do not use

    on damaged or broken skin.

    Stop use and ask doctor

    if rash occurs.

    Keep out of reach of children.

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

  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Reapply at least every 2 hours.
    • Sun protection measures: 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 10 a.m. - 2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses.
    • Use a water-resistant sunscreen if swimming or sweating.
    • Children under 6 months: Ask a doctor.
  • Inactive ingredients

    Water (Aqua/Eau), Dicaprylyl Carbonate, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Isosorbide Dicaprylate, Squalane, Glycerin, Dimethicone, Propanediol, Coco-Glucoside, Polyhydroxystearic Acid, Oryza Sativa (Rice) Bran Extract, Quercus Suber Bark Extract, Cucumis Sativus (Cucumber) Fruit Extract, Magnolia Officinalis Bark Extract, Vitis Vinifera (Grape) Seed Extract, Oak Root Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Cocos Nucifera (Coconut) Oil, Jojoba Esters, Glutathione, Tocopherol, Caprylhydroxamic Acid, Sodium Stearoyl Glutamate, Trisodium Ethylenediamine Disuccinate, Polyglyceryl-6 Polyricinoleate, Glyceryl Caprylate, Glyceryl Oleate Citrate, Cetearyl Glucoside, Maltodextrin, Lecithin, Acacia Senegal Gum, Xanthan Gum, Silica, Caprylyl Glycol, Pentylene Glycol, Sodium Benzoate, Iron Oxides (CI 77491, CI 77492).

  • Other information

    Protect this product from excessive heat and direct sun.

  • Questions or comments?

    Contact our sun specialists

    1 888 801 0414

    Hours: 9 AM - 5 PM PST

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    LION POSE GHOST-BUSTER BROAD SPECTRUM SPF 42 SUNSCREEN 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83605-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE150 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLUTATHIONE (UNII: GAN16C9B8O)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    QUERCUS SUBER BARK (UNII: 8R5219271Q)  
    CUCUMBER (UNII: YY7C30VXJT)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974)  
    ISOSORBIDE DICAPRYLATE (UNII: 0IK29C4889)  
    SQUALANE (UNII: GW89575KF9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ACACIA (UNII: 5C5403N26O)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    GLYCERYL MONOOLEATE CITRATE (UNII: NLE5KIG74K)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    RICE BRAN (UNII: R60QEP13IC)  
    POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83605-001-012 mL in 1 PACKET; Type 0: Not a Combination Product08/16/2023
    2NDC:83605-001-021 in 1 BOX08/16/2023
    250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02008/16/2023
    Labeler - Lion Pose Inc. (119057070)
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