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| Product NDC Code | 84616-002 | ||||
|---|---|---|---|---|---|
| Drug Name | Round lab birch juice mild-up uvlock sunscreen spf50 broad spectrum |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | SEORIN COMPANY Co., Ltd. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Zinc Oxide 17%
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.Directions apply liberally and evenly 15 minutes before sun exposure. Sun protection measures. Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m., wear long-sleeved shirts, pants, hats, and sunglasses children under 6 months of age: Ask a doctor reapply at least every 2 hours. use a water-resistant sunscreen if swimming or sweating
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Cyclohexasiloxane, Butyloctyl Salicylate, Propanediol, Propylheptyl Caprylate, Isododecane, Caprylyl Methicone, Polyglycery-3 Polydimethylsiloxyethyl Dimethicone, Methyl Methacrylate Crosspolymer, Methyl Trimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Triethoxycaprylysilane, 1,2-Hexanediol, Polyglyceryl-2 Dipolyhydroxystearate, Polymethylsilsesquioxane, Lauryl Polyglyceryl-3 Polydimethyisiloxyethyl Dimethicone, Butylene Glycol, Betula Platyphylla Japonica Juice, Glyceryl Caprylate, Caprylyl Glycol, Ethylhexy glycerin, Artemisia Ánnua Extract, Anthemis Nobilis Flower Oil, Sodium Hyaluronate, Pinus Sylvestris Leaf Oil, Glycerin, Nelumbo Nucifera Leaf Extract, Cryptomeria Japonica Leaf Extract, Saccharomyces Ferment Filtrate, Tocopherol, Glyceryl Glucoside, Hyaluronic Acid, Ascorbic Acid
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.Uses helps prevent sunburn if used as directed with other sun protection measures (see Directions ) decreases the risk of skin cancer and early skin aging caused by the sun.
Purpose
Information about the drug product’s indications for use.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Round Lab Birch Juice Mild-Up UVLOCK Sunscreen SPF50 Broad Spectrum Zinc Oxide POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) ARTEMISIA ANNUA LEAF HYALURONATE SODIUM TRIETHOXYCAPRYLYLSILANE CRYPTOMERIA JAPONICA LEAF ASCORBIC ACID WATER PROPYLHEPTYL CAPRYLATE DISTEARDIMONIUM HECTORITE BUTYLENE GLYCOL BUTYLOCTYL SALICYLATE CYCLOMETHICONE 6 METHYL TRIMETHICONE CAPRYLYL TRISILOXANE 1,2-HEXANEDIOL POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE CAPRYLYL GLYCOL ETHYLHEXYLGLYCERIN PINE NEEDLE OIL (PINUS SYLVESTRIS) ISODODECANE CHAMAEMELUM NOBILE FLOWER OIL POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) BETULA PLATYPHYLLA VAR. JAPONICA RESIN GLYCERYL CAPRYLATE NELUMBO NUCIFERA LEAF SACCHAROMYCES CEREVISIAE TOCOPHEROL ZINC OXIDE ZINC OXIDE PROPANEDIOL METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER MAGNESIUM SULFATE, UNSPECIFIED GLYCERIN GLYCERYL GLUCOSIDE HYALURONIC ACID
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.BIRCH JUICE MILD-UP UVLOCK SUNSCREEN SPF50+ Broad spectrum ROUND LAB 50nL 1.69fl. oz. SP
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other Information protect the product from excessive heat and direct sun
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on damaged or broken skin.
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.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? www.roundlab.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if rash occurs
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product keep out of eyes. Rinse with water to remove
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.Warnings 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 a doctor if rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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