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

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

Drug Labeling and Warnings

Sqween 100% Mineral Sunscreen Broad Spectrum SPF 30 Water Resistant by is a Otc medication manufactured, distributed, or labeled by SQWEEN LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product 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)