MEADOW AND BARK SPF 45 MINERAL SHIMMER SUNSCREEN- zinc oxide lotion

Meadow and Bark SPF 45 Mineral Shimmer Sunscreen by

Drug Labeling and Warnings

Meadow and Bark SPF 45 Mineral Shimmer Sunscreen by is a Otc medication manufactured, distributed, or labeled by Meadow and Bark, Stream2Sea, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 19%

PURPOSE

Sunscreen.

INDICATIONS & USAGE

Helps prevent sunburn.

WARNINGS

For external use only.

Do no 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 lease every 2 hours.

For children under 6 months of age: ask a doctor.

INACTIVE INGREDIENT

Aloe Barbadensis (Aloe) Leaf Juice*, Calcium Titanium Borosilicate and Titanium Dioxide, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Curcuma Longa (Turmeric) Root Extract*, Deionized Water, Diisostearoyl Polyglycery-3 Dimer Dilinoleate, Ethyl Lauroyl Arginate HCl, Extracts of Alaria Esculenta (Wakame Seaweed), Camelia Sinensis (Green Tea) Leaf*, Ocimum Tenuiflorum (Tulsi) Leaf*, Olea Europa (Olive) Leaf* in Cocos Nucifera (Coconut) Oil, Iron Oxides (CI 77492, CI 77491, CI 77499), Isoamyl Laurate, Jojoba Esters, Mica, Mixed Tocopherols, Olive Squalane Oil, Polyglyceryl-3 Oleate, Polyhydroxystearic Acid, Olive Squalane Oil, Polyglceryl-3 Oleate, Polyhydroxystearic Acid, Propanediol, Silica, Sodium Chloride, Sodium Stearoyl Glutamate, Tetrasodium Glutamate Diacetate, Vegetarian Glycerin, Xanthan Gum, *ORGANIC INGREDIENTS

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEADOW AND BARK SPF 45 MINERAL SHIMMER SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84199-046
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	19 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BOROSILICATE GLASS (UNII: BOJ6T9AR90)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PROPANEDIOL (UNII: 5965N8W85T)
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
TOCOPHEROL (UNII: R0ZB2556P8)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALARIA ESCULENTA (UNII: EJ9JK8J58D)
SQUALANE (UNII: GW89575KF9)
POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)
MICA (UNII: V8A1AW0880)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
COCONUT OIL (UNII: Q9L0O73W7L)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
HOLY BASIL LEAF (UNII: SCJ765569P)
ETHYL LAUROYL ARGINATE HYDROCHLORIDE (UNII: XPD6ZY79TB)
WATER (UNII: 059QF0KO0R)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TURMERIC (UNII: 856YO1Z64F)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84199-046-02	75 mL in 1 TUBE; Type 0: Not a Combination Product	03/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/29/2024

Labeler - Meadow and Bark (104407707)

Establishment
Name	Address	ID/FEI	Business Operations
Stream2Sea, LLC		052920828	manufacture(84199-046)