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| Product NDC Code | 62839-3954 | ||||
|---|---|---|---|---|---|
| Drug Name | Nu colour bioadaptive bb plus foundation - java |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | part352 | ||||
| Labeler Name | NSE Products, Inc. | ||||
| 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 Ingredient Titanium Dioxide 5%
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. Children under 6 months of age: Ask a doctor Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating 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 SPF 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water (Aqua), Phenyl Trimethicone, Dimethicone, Butylene Glycol Dicaprylate/Dicaprate, Butylene Glycol, Acrylates Copolymer, Butyloctyl Salicylate, Squalane, Cetyl PEG/PPG- 10/1 Dimethicone, Pentylene Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, Hexyl Laurate, Glycerin, Polyglyceryl-4 Isostearate, Magnesium Stearate, Disteardimonium Hectorite, Magnesium Sulfate, Phenoxyethanol, Tribehenin, Sorbitan Sesquioleate, Ethylhexyl Palmitate, Triethoxycaprylylsilane, Stearic Acid, Hydrogenated Olive Oil Unsaponifiables, Alumina, Methyl Methacrylate Crosspolymer, Synthetic Fluorphlogopite, Aluminum Hydroxide, Ethylhexylglycerin, Sodium Hyaluronate, Theobroma Cacao (Cocoa) Seed Extract, Rosa Damascena Flower Extract, Saccharomyces Ferment Filtrate, Trihydroxystearin, Glucomannan, Propanediol, 1,2-Hexanediol, Tin Oxide, Disodium EDTA, Mica (CI 77019), Iron Oxides (CI 77491, CI 77492, CI 77499).
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.Use Helps prevent sunburn. Higher SPF gives more sun protection. 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. Smooth over face and neck, blending well. Seal with powder if desired.
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.Nu Colour Bioadaptive BB Plus Foundation - Java Titanium Dioxide Titanium Dioxide Titanium Dioxide WATER Phenyl Trimethicone Dimethicone FERRIC OXIDE YELLOW FERRIC OXIDE RED Butylene Glycol Dicaprylate/Dicaprate Butylene Glycol FERROSOFERRIC OXIDE Butyloctyl Salicylate Squalane Pentylene Glycol MICA Hexyl Laurate Glycerin Polyglyceryl-4 Isostearate Magnesium Stearate Disteardimonium Hectorite MAGNESIUM SULFATE, UNSPECIFIED FORM Phenoxyethanol Triethoxycaprylylsilane Sorbitan Sesquioleate Tribehenin Ethylhexyl Palmitate Hydrogenated Olive Oil Unsaponifiables METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE Stearic Acid ALUMINUM OXIDE Ethylhexylglycerin ROSA X DAMASCENA FLOWER EDETATE DISODIUM ANHYDROUS COCOA Trihydroxystearin Propanediol 1,2-Hexanediol STANNIC OXIDE HYALURONATE SODIUM KONJAC MANNAN Nu Colour Bioadaptive BB Plus Foundation - Espresso Titanium Dioxide Titanium Dioxide Titanium Dioxide WATER Phenyl Trimethicone Dimethicone FERRIC OXIDE YELLOW FERRIC OXIDE RED Butylene Glycol Dicaprylate/Dicaprate FERROSOFERRIC OXIDE Butylene Glycol Butyloctyl Salicylate Squalane Pentylene Glycol MICA Hexyl Laurate Glycerin Polyglyceryl-4 Isostearate Magnesium Stearate Disteardimonium Hectorite MAGNESIUM SULFATE, UNSPECIFIED FORM Phenoxyethanol Triethoxycaprylylsilane Sorbitan Sesquioleate Tribehenin Ethylhexyl Palmitate Hydrogenated Olive Oil Unsaponifiables METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE Stearic Acid ALUMINUM OXIDE Ethylhexylglycerin ROSA X DAMASCENA FLOWER EDETATE DISODIUM ANHYDROUS COCOA Trihydroxystearin Propanediol 1,2-Hexanediol STANNIC OXIDE HYALURONATE SODIUM KONJAC MANNAN
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.PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Java NU COLOUR ® NU BIOADAPTIVE BB+ SKIN LOVING FOUNDATION Broad Spectrum SPF 35 30 mL e 1 Fl Oz PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Java
PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Espresso NU COLOUR ® NU BIOADAPTIVE BB+ SKIN LOVING FOUNDATION Broad Spectrum SPF 35 30 mL e 1 Fl Oz PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Espresso
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.Drug Facts
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 the 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? 1-888-742-7626
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 a 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.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Protect this product from excessive heat and direct sun.
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. Stop use and ask a doctor if a rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of the 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