Label: SQWEEN 100% MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 WATER RESISTANT- zinc oxide lotion
- NDC Code(s): 83005-0001-1
- Packager: SQWEEN LLC
- 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- Uses
- Warning
-
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
- Sqween 100% Mineral Sunscreen Broad Spectrum SPF 30 Water Resistant
-
INGREDIENTS AND APPEARANCE
SQWEEN 100% MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 WATER RESISTANT
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83005-0001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 150 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:83005-0001-1 60 mL in 1 TUBE; Type 0: Not a Combination Product 01/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/01/2023 Labeler - SQWEEN LLC (118793162) Registrant - SQWEEN LLC (118793162)