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Product NDC Code | 54111-120 | ||||
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Drug Name | Rodan and fields enhancements medium |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | POWDER | ||||
Application Number | M020 | ||||
Labeler Name | Bentley Laboratories, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active ingredients Titanium Dioxide 9.6% Zinc Oxide 4.9%
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 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum 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 sleeve shirts, pants, hats, and sunglasses Children under 6 months: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Mica, Polymetylsilsesquioxane, Squalane, Water, Silia, Bismuth Oxychloride, Stearic Acid, Aluminum Hydroxide, Ceramide 3, Cholesterol, Phytosphingosine, Phenoxyethanol, Butylene Glycol, Caprylyl Glycol, Barium Sulfate, Angelica Polymorpha Sinensis Root Extract, HDI/Trimethylol Hexyllactone Crosspolymer, Potassium Sorbate, Hexylene Glycol, Dimethylacrlamide/Acrylic Acid/Polystyrene Ethyl Methacrylate Copolymer, Tranexamic Acid, Triethoxycaprylylsilane, Peat Extract, Trimyristin, Hydrogenated Lecithin, Oligopeptide-10, Tetrapeptide-14, Honey Extrac, Boswellia Serrata Extract, Resveratrol Lecithin, Silver. May contain: Iron Oxides, Titanium Dioxide.
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
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.RODAN and FIELDS ENHANCEMENTS LIGHT TITANIUM DIOXIDE, ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE MICA POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) SQUALANE WATER SILICON DIOXIDE BISMUTH OXYCHLORIDE STEARIC ACID ALUMINUM HYDROXIDE CERAMIDE 3 CHOLESTEROL PHYTOSPHINGOSINE PHENOXYETHANOL BUTYLENE GLYCOL CAPRYLYL GLYCOL BARIUM SULFATE ANGELICA SINENSIS ROOT HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER POTASSIUM SORBATE HEXYLENE GLYCOL TRANEXAMIC ACID TRIETHOXYCAPRYLYLSILANE TRIMYRISTIN HYDROGENATED SOYBEAN LECITHIN HONEY INDIAN FRANKINCENSE RESVERATROL LECITHIN, SOYBEAN SILVER FERRIC OXIDE RED FERRIC OXIDE YELLOW RODAN and FIELDS ENHANCEMENTS MEDIUM TITANIUM DIOXIDE, ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE MICA POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) SQUALANE WATER SILICON DIOXIDE BISMUTH OXYCHLORIDE STEARIC ACID ALUMINUM HYDROXIDE CERAMIDE 3 CHOLESTEROL PHYTOSPHINGOSINE PHENOXYETHANOL BUTYLENE GLYCOL CAPRYLYL GLYCOL BARIUM SULFATE ANGELICA SINENSIS ROOT HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER POTASSIUM SORBATE HEXYLENE GLYCOL TRANEXAMIC ACID TRIETHOXYCAPRYLYLSILANE TRIMYRISTIN HYDROGENATED SOYBEAN LECITHIN HONEY INDIAN FRANKINCENSE RESVERATROL LECITHIN, SOYBEAN SILVER FERRIC OXIDE RED FERRIC OXIDE YELLOW RODAN and FIELDS ENHANCEMENTS BRONZE TITANIUM DIOXIDE, ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE MICA POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) SQUALANE WATER SILICON DIOXIDE BISMUTH OXYCHLORIDE STEARIC ACID ALUMINUM HYDROXIDE CERAMIDE 3 CHOLESTEROL PHYTOSPHINGOSINE PHENOXYETHANOL BUTYLENE GLYCOL CAPRYLYL GLYCOL BARIUM SULFATE ANGELICA SINENSIS ROOT HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER POTASSIUM SORBATE HEXYLENE GLYCOL TRANEXAMIC ACID TRIETHOXYCAPRYLYLSILANE TRIMYRISTIN HYDROGENATED SOYBEAN LECITHIN HONEY INDIAN FRANKINCENSE RESVERATROL LECITHIN, SOYBEAN SILVER FERRIC OXIDE RED FERRIC OXIDE YELLOW
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.Rodan + Fields ENHANCEMENTS - Light, Medium, Bronze Product Labels escription for Change™ RODAN+FIELDS® ENHANCEMENTS Mineral Peptides BROAD SPECTRUM SPF 20 RODAN+FIELDS® DERMATOLOGISTS 4g/0.14 Oz. Manufactured for Rodan and Fields, LLC 111 Maiden Lane, Suite 400 San Francisco CA 94108 Made in the USA Please Recycle visit rodanand fields.com QUESTIONS OR COMMENTS 1-888-995-5656 Light ENPL004 08-03-0023 Medium ENPM004 80-03-0024 Bronze ENPB004 80-03-0025 res RF MineralPep Light Label RF MineralPep Light1 Label RF MineralPep Medium Label RF MineralPep Bronze Label
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 each of children. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Protect this product from excessive heat and direct sun.
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
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