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Product NDC Code | 84199-046 | ||||
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Drug Name | Meadow and bark spf 45 mineral shimmer sunscreen |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
Application Number | M020 | ||||
Labeler Name | Meadow and Bark | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Zinc Oxide 19%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Helps prevent sunburn.
Purpose
Information about the drug product’s indications for use.Sunscreen.
Spl product data elements
Usually a list of ingredients in a drug product.Meadow and Bark SPF 45 Mineral Shimmer Sunscreen Zinc Oxide BOROSILICATE GLASS POLYHYDROXYSTEARIC ACID (2300 MW) PROPANEDIOL DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE OLEA EUROPAEA LEAF TOCOPHEROL GREEN TEA LEAF ISOAMYL LAURATE MEDIUM-CHAIN TRIGLYCERIDES ALARIA ESCULENTA SQUALANE POLYGLYCERYL-3 OLEATE MICA SODIUM CHLORIDE GLYCERIN XANTHAN GUM COCONUT OIL JOJOBA OIL, RANDOMIZED HOLY BASIL LEAF ETHYL LAUROYL ARGINATE HYDROCHLORIDE WATER COCO-CAPRYLATE/CAPRATE TETRASODIUM GLUTAMATE DIACETATE ZINC OXIDE ZINC OXIDE ALOE VERA LEAF TURMERIC SODIUM STEAROYL GLUTAMATE SILICON DIOXIDE TITANIUM DIOXIDE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Label
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.If product is swallowed, get medical help or contact a Poison Control Center right away.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API