Label: SQWEEN 100% MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 WATER RESISTANT- zinc oxide lotion

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

Drug Label Information

Updated November 7, 2023

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

  • Drug Facts

  • Active Ingredients

    Zinc Oxide 15%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent surnburn. If used as directed with other sun protection measures (See  ), decreases the risk of skin cancer and early skin aging caused by the skin. Directions

  • Warning

    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 doctor

    if rash occurs.

    Keep out of reach of children.

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

  • Directions

    Apply liberally to exposed areas 15 minutes before sun exposure.

    Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel drying.

    •  Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other protection measures including Sun Protection Measures
    • Limit time in the sun, especially from 10 a.m. - 2 p.m.
    • Wear long-sleeve shirts, pants, hats, and sunglasses
    • Children under 6 months: ask a doctor.
  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, C15-19 Alkane, Isocetyl Stearoyl Stearate, Undecane, Tribehenin, Silica, Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil, Capryloyl Glycerin/Sebacic Acid Copolymer, Glyceryl Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, Tridecane, Leuconostoc/Radish Root Ferment Filtrate, Lactobacillus, Aloe Barbadensis Leaf, Hyaluronic Acid, Acacia Senegal Gum, Xanthan Gum, Cocos Nucifera (Coconut) Fruit Extract May Contain: Indigofera Tinctoria Leaf Extract, Caesalpinia Sappan Bark Extract, Synthetic Fluorphlogopite, Titanium Dioxide, Tin Oxide









  • Other Information

    Protect this product from excessive heat and direct sun.

    Contact for Questions: (877) 849-1983

    Distributed by SQWEEN, LLC: New York, NY 10065

    MADE IN THE USA with US & imported materials

  • Sqween 100% Mineral Sunscreen Broad Spectrum SPF 30 Water Resistant

    Sqween 100% Mineral Sunscreen

  • INGREDIENTS AND APPEARANCE
    SQWEEN 100% MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 WATER RESISTANT 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83005-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION150 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    C15-19 ALKANE (UNII: CI87N1IM01)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    UNDECANE (UNII: JV0QT00NUE)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TRIDECANE (UNII: A3LZF0L939)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    ACACIA (UNII: 5C5403N26O)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    COCONUT (UNII: 3RT3536DHY)  
    INDIGOFERA TINCTORIA LEAF (UNII: 2K7DF8HZDM)  
    BIANCAEA SAPPAN BARK (UNII: R6995U1QSX)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83005-0001-160 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2023
    Labeler - SQWEEN LLC (118793162)
    Registrant - SQWEEN LLC (118793162)