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Shiseido the makeup foundation i60 - Medication Information

Product NDC Code 58411-460
Drug Name

Shiseido the makeup foundation i60

Type Brand
Active Ingredients
Titanium dioxide 400 mg/10g
Route TOPICAL
Dosage Form STICK
Application Number M020
Labeler Name SHISEIDO AMERICAS CORPORATION
Packages
Package NDC Code Description
58411-460-20 1 cartridge in 1 carton (58411-460-20) / 10 g in 1 cartridge
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Titanium Dioxide 4.1%

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 children under 6 months: ask a doctor 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 CYCLOHEXASILOXANE ∙ TRIETHYLHEXANOIN ∙ DIMETHICONE ∙ KAOLIN ∙ CYCLOPENTASILOXANE ∙ PARAFFIN ∙ SORBITAN SESQUIISOSTEARATE ∙ EUPHORBIA CERIFERA (CANDELILLA) WAX ∙ PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE ∙ TOCOPHERYL ACETATE ∙ POLYMETHYL METHACRYLATE ∙ COPERNICIA CERIFERA (CARNAUBA) WAX ∙ ALUMINUM HYDROXIDE ∙ STEARIC ACID ∙ MICROCRYSTALLINE WAX ∙ ALUMINA ∙ GLYCERIN ∙ TOCOPHEROL ∙ ZINC OXIDE ∙ BHT ∙ FRAGRANCE ∙ MICA ∙ TITANIUM DIOXIDE ∙ IRON OXIDES ∙ ULTRAMARINES ∙

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.
SHISEIDO THE MAKEUP FOUNDATION I20 TITANIUM DIOXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE CYCLOMETHICONE 6 TRIETHYLHEXANOIN DIMETHICONE KAOLIN CYCLOMETHICONE 5 PARAFFIN SORBITAN SESQUIISOSTEARATE CANDELILLA WAX PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE .ALPHA.-TOCOPHEROL ACETATE, DL- POLY(METHYL METHACRYLATE; 450000 MW) CARNAUBA WAX ALUMINUM HYDROXIDE STEARIC ACID MICROCRYSTALLINE WAX ALUMINUM OXIDE GLYCERIN .ALPHA.-TOCOPHEROL ZINC OXIDE BUTYLATED HYDROXYTOLUENE MICA FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE SHISEIDO THE MAKEUP FOUNDATION I40 TITANIUM DIOXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE CYCLOMETHICONE 6 TRIETHYLHEXANOIN DIMETHICONE KAOLIN CYCLOMETHICONE 5 PARAFFIN SORBITAN SESQUIISOSTEARATE CANDELILLA WAX PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE .ALPHA.-TOCOPHEROL ACETATE, DL- POLY(METHYL METHACRYLATE; 450000 MW) CARNAUBA WAX ALUMINUM HYDROXIDE STEARIC ACID MICROCRYSTALLINE WAX ALUMINUM OXIDE GLYCERIN .ALPHA.-TOCOPHEROL ZINC OXIDE BUTYLATED HYDROXYTOLUENE MICA FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE SHISEIDO THE MAKEUP FOUNDATION I60 TITANIUM DIOXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE CYCLOMETHICONE 6 TRIETHYLHEXANOIN DIMETHICONE KAOLIN CYCLOMETHICONE 5 PARAFFIN SORBITAN SESQUIISOSTEARATE CANDELILLA WAX PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE .ALPHA.-TOCOPHEROL ACETATE, DL- POLY(METHYL METHACRYLATE; 450000 MW) CARNAUBA WAX ALUMINUM HYDROXIDE STEARIC ACID MICROCRYSTALLINE WAX ALUMINUM OXIDE GLYCERIN .ALPHA.-TOCOPHEROL ZINC OXIDE BUTYLATED HYDROXYTOLUENE MICA FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE SHISEIDO THE MAKEUP FOUNDATION B20 TITANIUM DIOXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE CYCLOMETHICONE 6 TRIETHYLHEXANOIN DIMETHICONE KAOLIN CYCLOMETHICONE 5 PARAFFIN SORBITAN SESQUIISOSTEARATE CANDELILLA WAX PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE .ALPHA.-TOCOPHEROL ACETATE, DL- POLY(METHYL METHACRYLATE; 450000 MW) CARNAUBA WAX ALUMINUM HYDROXIDE STEARIC ACID MICROCRYSTALLINE WAX ALUMINUM OXIDE GLYCERIN .ALPHA.-TOCOPHEROL ZINC OXIDE BUTYLATED HYDROXYTOLUENE MICA FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE SHISEIDO THE MAKEUP FOUNDATION B40 TITANIUM DIOXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE CYCLOMETHICONE 6 TRIETHYLHEXANOIN DIMETHICONE KAOLIN CYCLOMETHICONE 5 PARAFFIN SORBITAN SESQUIISOSTEARATE CANDELILLA WAX PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE .ALPHA.-TOCOPHEROL ACETATE, DL- POLY(METHYL METHACRYLATE; 450000 MW) CARNAUBA WAX ALUMINUM HYDROXIDE STEARIC ACID MICROCRYSTALLINE WAX ALUMINUM OXIDE GLYCERIN .ALPHA.-TOCOPHEROL ZINC OXIDE BUTYLATED HYDROXYTOLUENE MICA FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE SHISEIDO THE MAKEUP FOUNDATION B60 TITANIUM DIOXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE CYCLOMETHICONE 6 TRIETHYLHEXANOIN DIMETHICONE KAOLIN CYCLOMETHICONE 5 PARAFFIN SORBITAN SESQUIISOSTEARATE CANDELILLA WAX PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE .ALPHA.-TOCOPHEROL ACETATE, DL- POLY(METHYL METHACRYLATE; 450000 MW) CARNAUBA WAX ALUMINUM HYDROXIDE STEARIC ACID MICROCRYSTALLINE WAX ALUMINUM OXIDE GLYCERIN .ALPHA.-TOCOPHEROL ZINC OXIDE BUTYLATED HYDROXYTOLUENE MICA FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE

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 - 10 g Cartridge Carton - I 20 I 20 SHISEIDO The Makeup Stick Foundation BROAD SPECTRUM SPF 20 sunscreen 10g NET WT. .35 OZ. PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - I 20 PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - I 40 I 40 SHISEIDO The Makeup Stick Foundation BROAD SPECTRUM SPF 20 sunscreen 10g NET WT. .35 OZ. PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - I 40 PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - I 60 I 60 SHISEIDO The Makeup Stick Foundation BROAD SPECTRUM SPF 20 sunscreen 10g NET WT. .35 OZ. PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - I 60 PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - B 20 B 20 SHISEIDO The Makeup Stick Foundation BROAD SPECTRUM SPF 20 sunscreen 10g NET WT. .35 OZ. PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - B 20 PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - B 40 B 40 SHISEIDO The Makeup Stick Foundation BROAD SPECTRUM SPF 20 sunscreen 10g NET WT. .35 OZ. PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - B 40 PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - B 60 B 60 SHISEIDO The Makeup Stick Foundation BROAD SPECTRUM SPF 20 sunscreen 10g NET WT. .35 OZ. PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - B 60

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