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Cle de peau beaute concealer beige - Medication Information

Product NDC Code 58411-355
Drug Name

Cle de peau beaute concealer beige

Type Brand
Active Ingredients
Titanium dioxide 80 mg/5g
Route TOPICAL
Dosage Form STICK
Application Number part352
Labeler Name SHISEIDO AMERICAS CORPORATION
Packages
Package NDC Code Description
58411-355-40 1 tube in 1 carton (58411-355-40) / 5 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients TITANIUM DIOXIDE 1.6%

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 For sunscreen use: 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 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-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 HYDROGENATED POLYDECENE∙CYCLOPENTASILOXANE∙KAOLIN∙DIPHENYLSILOXY PHENYL TRIMETHICONE∙PARAFFIN∙SODIUM MAGNESIUM SILICATE∙DIISOSTEARYL MALATE∙POLYETHYLENE∙SORBITAN SESQUIISOSTEARATE∙GLYCERIN∙COPERNICIA CERIFERA (CARNAUBA) WAX∙BARIUM SULFATE∙PHYTOSTERYL MACADAMIATE∙TOCOPHERYL ACETATE∙SODIUM ACETYLATED HYALURONATE∙ROSA ROXBURGHII FRUIT EXTRACT∙CAMELLIA SINENSIS LEAF EXTRACT∙PRUNUS SPECIOSA LEAF EXTRACT∙MICROCRYSTALLINE WAX∙DIPROPYLENE GLYCOL∙PEG-10 DIMETHICONE∙ALUMINA∙WATER∙ALUMINUM HYDROXIDE∙STEARIC ACID∙SYNTHETIC FLUORPHLOGOPITE∙BUTYLENE GLYCOL∙TOCOPHEROL∙ALCOHOL∙SIMETHICONE∙TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE∙DIMETHICONE∙BHT∙FRAGRANCE∙TITANIUM DIOXIDE∙IRON OXIDES∙MICA∙

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.
CLE DE PEAU BEAUTE CONCEALER IVORY TITANIUM DIOXIDE HYDROGENATED POLYDECENE (550 MW) CYCLOMETHICONE 5 KAOLIN DIPHENYLSILOXY PHENYL TRIMETHICONE PARAFFIN DIISOSTEARYL MALATE HIGH DENSITY POLYETHYLENE SORBITAN SESQUIISOSTEARATE GLYCERIN CARNAUBA WAX BARIUM SULFATE PHYTOSTERYL MACADAMIATE .ALPHA.-TOCOPHEROL ACETATE SODIUM ACETYLATED HYALURONATE ROSA ROXBURGHII FRUIT GREEN TEA LEAF PRUNUS SPECIOSA LEAF MICROCRYSTALLINE WAX DIPROPYLENE GLYCOL PEG-10 DIMETHICONE (600 CST) ALUMINUM OXIDE WATER ALUMINUM HYDROXIDE STEARIC ACID BUTYLENE GLYCOL TOCOPHEROL ALCOHOL DIMETHICONE BUTYLATED HYDROXYTOLUENE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE MICA TITANIUM DIOXIDE TITANIUM DIOXIDE CLE DE PEAU BEAUTE CONCEALER OCHER TITANIUM DIOXIDE HYDROGENATED POLYDECENE (550 MW) CYCLOMETHICONE 5 KAOLIN DIPHENYLSILOXY PHENYL TRIMETHICONE PARAFFIN DIISOSTEARYL MALATE HIGH DENSITY POLYETHYLENE SORBITAN SESQUIISOSTEARATE GLYCERIN CARNAUBA WAX BARIUM SULFATE PHYTOSTERYL MACADAMIATE .ALPHA.-TOCOPHEROL ACETATE SODIUM ACETYLATED HYALURONATE ROSA ROXBURGHII FRUIT GREEN TEA LEAF PRUNUS SPECIOSA LEAF MICROCRYSTALLINE WAX DIPROPYLENE GLYCOL PEG-10 DIMETHICONE (600 CST) ALUMINUM OXIDE WATER ALUMINUM HYDROXIDE STEARIC ACID BUTYLENE GLYCOL TOCOPHEROL ALCOHOL DIMETHICONE BUTYLATED HYDROXYTOLUENE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE MICA TITANIUM DIOXIDE TITANIUM DIOXIDE CLE DE PEAU BEAUTE CONCEALER BEIGE TITANIUM DIOXIDE HYDROGENATED POLYDECENE (550 MW) CYCLOMETHICONE 5 KAOLIN DIPHENYLSILOXY PHENYL TRIMETHICONE PARAFFIN DIISOSTEARYL MALATE HIGH DENSITY POLYETHYLENE SORBITAN SESQUIISOSTEARATE GLYCERIN CARNAUBA WAX BARIUM SULFATE PHYTOSTERYL MACADAMIATE .ALPHA.-TOCOPHEROL ACETATE SODIUM ACETYLATED HYALURONATE ROSA ROXBURGHII FRUIT GREEN TEA LEAF PRUNUS SPECIOSA LEAF MICROCRYSTALLINE WAX DIPROPYLENE GLYCOL PEG-10 DIMETHICONE (600 CST) ALUMINUM OXIDE WATER ALUMINUM HYDROXIDE STEARIC ACID BUTYLENE GLYCOL TOCOPHEROL ALCOHOL DIMETHICONE BUTYLATED HYDROXYTOLUENE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE MICA TITANIUM DIOXIDE TITANIUM DIOXIDE CLE DE PEAU BEAUTE CONCEALER HONEY TITANIUM DIOXIDE HYDROGENATED POLYDECENE (550 MW) CYCLOMETHICONE 5 KAOLIN DIPHENYLSILOXY PHENYL TRIMETHICONE PARAFFIN DIISOSTEARYL MALATE HIGH DENSITY POLYETHYLENE SORBITAN SESQUIISOSTEARATE GLYCERIN CARNAUBA WAX BARIUM SULFATE PHYTOSTERYL MACADAMIATE .ALPHA.-TOCOPHEROL ACETATE SODIUM ACETYLATED HYALURONATE ROSA ROXBURGHII FRUIT GREEN TEA LEAF PRUNUS SPECIOSA LEAF MICROCRYSTALLINE WAX DIPROPYLENE GLYCOL PEG-10 DIMETHICONE (600 CST) ALUMINUM OXIDE WATER ALUMINUM HYDROXIDE STEARIC ACID BUTYLENE GLYCOL TOCOPHEROL ALCOHOL DIMETHICONE BUTYLATED HYDROXYTOLUENE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE MICA TITANIUM DIOXIDE TITANIUM DIOXIDE CLE DE PEAU BEAUTE CONCEALER ALMOND TITANIUM DIOXIDE HYDROGENATED POLYDECENE (550 MW) CYCLOMETHICONE 5 KAOLIN DIPHENYLSILOXY PHENYL TRIMETHICONE PARAFFIN DIISOSTEARYL MALATE HIGH DENSITY POLYETHYLENE SORBITAN SESQUIISOSTEARATE GLYCERIN CARNAUBA WAX BARIUM SULFATE PHYTOSTERYL MACADAMIATE .ALPHA.-TOCOPHEROL ACETATE SODIUM ACETYLATED HYALURONATE ROSA ROXBURGHII FRUIT GREEN TEA LEAF PRUNUS SPECIOSA LEAF MICROCRYSTALLINE WAX DIPROPYLENE GLYCOL PEG-10 DIMETHICONE (600 CST) ALUMINUM OXIDE WATER ALUMINUM HYDROXIDE STEARIC ACID BUTYLENE GLYCOL TOCOPHEROL ALCOHOL DIMETHICONE BUTYLATED HYDROXYTOLUENE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE MICA TITANIUM DIOXIDE TITANIUM DIOXIDE CLE DE PEAU BEAUTE CONCEALER MOCHA TITANIUM DIOXIDE HYDROGENATED POLYDECENE (550 MW) CYCLOMETHICONE 5 KAOLIN DIPHENYLSILOXY PHENYL TRIMETHICONE PARAFFIN DIISOSTEARYL MALATE HIGH DENSITY POLYETHYLENE SORBITAN SESQUIISOSTEARATE GLYCERIN CARNAUBA WAX BARIUM SULFATE PHYTOSTERYL MACADAMIATE .ALPHA.-TOCOPHEROL ACETATE SODIUM ACETYLATED HYALURONATE ROSA ROXBURGHII FRUIT GREEN TEA LEAF PRUNUS SPECIOSA LEAF MICROCRYSTALLINE WAX DIPROPYLENE GLYCOL PEG-10 DIMETHICONE (600 CST) ALUMINUM OXIDE WATER ALUMINUM HYDROXIDE STEARIC ACID BUTYLENE GLYCOL TOCOPHEROL ALCOHOL DIMETHICONE BUTYLATED HYDROXYTOLUENE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE MICA TITANIUM 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.
PRINCIPAL DISPLAY PANEL - 5 g Tube Carton - IVORY clé de peau BEAUTÉ concealer BROAD SPECTRUM SPF 25 SUNSCREEN 5g NET WT. .17 OZ. PRINCIPAL DISPLAY PANEL - 5 g Tube Carton - IVORY PRINCIPAL DISPLAY PANEL - 5 g Tube Carton - OCHER clé de peau BEAUTÉ concealer BROAD SPECTRUM SPF 25 SUNSCREEN 5g NET WT. .17 OZ. PRINCIPAL DISPLAY PANEL - 5 g Tube Carton - OCHER PRINCIPAL DISPLAY PANEL - 5 g Tube Carton - BEIGE clé de peau BEAUTÉ concealer BROAD SPECTRUM SPF 25 SUNSCREEN 5g NET WT. .17 OZ. PRINCIPAL DISPLAY PANEL - 5 g Tube Carton - BEIGE PRINCIPAL DISPLAY PANEL - 5 g Tube Carton - HONEY clé de peau BEAUTÉ concealer BROAD SPECTRUM SPF 25 SUNSCREEN 5g NET WT. .17 OZ. PRINCIPAL DISPLAY PANEL - 5 g Tube Carton - HONEY PRINCIPAL DISPLAY PANEL - 5 g Tube Carton - ALMOND clé de peau BEAUTÉ concealer BROAD SPECTRUM SPF 25 SUNSCREEN 5g NET WT. .17 OZ. PRINCIPAL DISPLAY PANEL - 5 g Tube Carton - ALMOND PRINCIPAL DISPLAY PANEL - 5 g Tube Carton - MOCHA clé de peau BEAUTÉ concealer BROAD SPECTRUM SPF 25 SUNSCREEN 5g NET WT. .17 OZ. PRINCIPAL DISPLAY PANEL - 5 g Tube Carton - MOCHA

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 reach of children. If product is 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? Call toll free 1-800-906-7503

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.

Storage and handling

Information about safe storage and handling of the drug product.
Other information protect this product in this container 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 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 product is 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