FDA.reportPublic FDA data

Meadow and Bark SPF 45 Mineral Shimmer Sunscreen

Manufacturer
Meadow and Bark | Stream2Sea, LLC
Effective date
2024-04-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:10:34

Label at a glance#

ProductMeadow and Bark SPF 45 Mineral Shimmer Sunscreen
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 19%

OTC - PURPOSE SECTION

Sunscreen.

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84199-046-02Meadow and Bark SPF 45 Mineral Shimmer Sunscreen75 mL in 1 TUBELOTION752

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84199-046MEADOW AND BARK SPF 45 MINERAL SHIMMER SUNSCREEN (ZINC OXIDE) LOTION [MEADOW AND BARK]2Current NDC, 1 package rows20240404_14bbd191-ef3b-628e-e063-6294a90a1e66.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84199-04684199-046-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
BOROSILICATE GLASSBOJ6T9AR90IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
PROPANEDIOL5965N8W85TIACT
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATEG3232Z5S2OIACT
OLEA EUROPAEA LEAFMJ95C3OH47IACT
TOCOPHEROLR0ZB2556P8IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ISOAMYL LAURATEM1SLX00M3MIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ALARIA ESCULENTAEJ9JK8J58DIACT
SQUALANEGW89575KF9IACT
POLYGLYCERYL-3 OLEATEXRQ165498BIACT
MICAV8A1AW0880IACT
SODIUM CHLORIDE451W47IQ8XIACT
GLYCERINPDC6A3C0OXIACT
XANTHAN GUMTTV12P4NEEIACT
COCONUT OILQ9L0O73W7LIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
HOLY BASIL LEAFSCJ765569PIACT
ETHYL LAUROYL ARGINATE HYDROCHLORIDEXPD6ZY79TBIACT
WATER059QF0KO0RIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
ZINC OXIDESOI2LOH54ZACTIB
ALOE VERA LEAFZY81Z83H0XIACT
TURMERIC856YO1Z64FIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meadow and Bark SPF 45 Mineral Shimmer SunscreenZINC OXIDEMeadow and Bark14bbd191-ef3b-628e-e063-6294a90a1e662024-04-03WarningsExact identifier
ndc (package): 84199-046-02
ndc (product): 84199-046
ndc11 (package): 84199004602
spl id: 15338e0d-429c-3e0b-e063-6294a90a50e9
spl set id: 14bbd191-ef3b-628e-e063-6294a90a1e66

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.