SUN WRANGLER DAILY MINERAL SUNSCREEN SPF 45- zinc oxide cream

Sun Wrangler Daily Mineral Sunscreen SPF 45 by

Drug Labeling and Warnings

Sun Wrangler Daily Mineral Sunscreen SPF 45 by is a Otc medication manufactured, distributed, or labeled by Sun Wrangler, Stream2Sea, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 19% (Non-Nano)

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn.

WARNINGS

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product, keep out of eyes. Rinse with water to remove.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

• Apply liberally 15 minutes before sun exposure.
• Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at least every 2 hours.
• For children under 6 months of age; ask a doctor.

OTHER SAFETY INFORMATION

Protect this product from excessive heat and sunlight.

INACTIVE INGREDIENT

Deionized Water, Aloe Barbadensis Leaf Juice*, Coco-Caprylate/Caprate, Isoamyl Laurate, Vegetarian Glycerin, Polyglyceryl- 3 Oleate, Propanediol, Polyhydroxystearic Acid, Diisostearoyl Polyglyceryl- 3 Dimer Dinoleate, Mica, Caprylic/Capric Triglyceride, Sodium Chloride, Ethyl lauroyl arginate HCl, Jojoba Esters, Olive Squalane Oil, Extracts of Alaria Esculenta (Wakame Seaweed), Olea Europa (Olive) Leaf*, Camellia Sinenis (Green Tea) Leaf*, Ocimum Tinuiflorum (Tulsi) Leaf*, Cocos Nucifera (Coconut) Oil, Curcuma Longa (Turmeric) Root* Extract, Tetrasodium Glutamate Diacetate, Mixed Tocopherols, Sodium Stearoyl Glutamate, Silica, Xanthan Gum, Calcium Titanium Borosilicate and Titanium.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUN WRANGLER DAILY MINERAL SUNSCREEN SPF 45 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84340-045
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	190 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCO-CAPRYLATE (UNII: 4828G836N6)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)
PROPANEDIOL (UNII: 5965N8W85T)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)
MICA (UNII: V8A1AW0880)
TRICAPRIN (UNII: O1PB8EU98M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ETHYL LAUROYL ARGINATE HYDROCHLORIDE (UNII: XPD6ZY79TB)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
OLIVE OIL (UNII: 6UYK2W1W1E)
ALARIA ESCULENTA (UNII: EJ9JK8J58D)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HOLY BASIL LEAF (UNII: SCJ765569P)
COCONUT OIL (UNII: Q9L0O73W7L)
TURMERIC (UNII: 856YO1Z64F)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84340-045-02	75 mL in 1 TUBE; Type 0: Not a Combination Product	07/12/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/12/2024

Labeler - Sun Wrangler (098704339)

Registrant - Stream2Sea, LLC (052920828)

Establishment
Name	Address	ID/FEI	Business Operations
Stream2Sea, LLC		052920828	manufacture(84340-045)