NDC 58411-620 Cle De Peau Beaute Concealer Cocoa

Titanium Dioxide

NDC Product Code 58411-620

NDC 58411-620-20

Package Description: 1 CARTRIDGE in 1 CARTON > 5 g in 1 CARTRIDGE

NDC Product Information

Cle De Peau Beaute Concealer Cocoa with NDC 58411-620 is a a human over the counter drug product labeled by Shiseido Americas Corporation. The generic name of Cle De Peau Beaute Concealer Cocoa is titanium dioxide. The product's dosage form is stick and is administered via topical form.

Labeler Name: Shiseido Americas Corporation

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Cle De Peau Beaute Concealer Cocoa Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • TITANIUM DIOXIDE 80 mg/5g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • MICA (UNII: V8A1AW0880)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • KAOLIN (UNII: 24H4NWX5CO)
  • DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • LAPONITE (UNII: D703131383)
  • DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • BARIUM SULFATE (UNII: 25BB7EKE2E)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • WATER (UNII: 059QF0KO0R)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • ALCOHOL (UNII: 3K9958V90M)
  • ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
  • SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • MICA (UNII: V8A1AW0880)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • KAOLIN (UNII: 24H4NWX5CO)
  • DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • LAPONITE (UNII: D703131383)
  • DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • BARIUM SULFATE (UNII: 25BB7EKE2E)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • WATER (UNII: 059QF0KO0R)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • ALCOHOL (UNII: 3K9958V90M)
  • ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
  • SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • MICA (UNII: V8A1AW0880)
  • KAOLIN (UNII: 24H4NWX5CO)
  • DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • LAPONITE (UNII: D703131383)
  • DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • BARIUM SULFATE (UNII: 25BB7EKE2E)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
  • WATER (UNII: 059QF0KO0R)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • ALCOHOL (UNII: 3K9958V90M)
  • ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
  • SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • MICA (UNII: V8A1AW0880)
  • KAOLIN (UNII: 24H4NWX5CO)
  • DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • LAPONITE (UNII: D703131383)
  • DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • BARIUM SULFATE (UNII: 25BB7EKE2E)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
  • WATER (UNII: 059QF0KO0R)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • ALCOHOL (UNII: 3K9958V90M)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
  • SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Shiseido Americas Corporation
Labeler Code: 58411
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-01-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Cle De Peau Beaute Concealer Cocoa Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Active Ingredients

TITANIUM DIOXIDE 1.6 %

Purpose

Sunscreen

Uses

  • Helps prevent sunburnif used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • For sunscreen use:apply liberally 15 minutes before sun exposureuse a water resistant sunscreen if swimming or sweatingreapply at least every two hoursSun 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 sunglasseschildren under 6 months: Ask a doctor

Inactive Ingredients

HYDROGENATED POLYDECENE▪CYCLOPENTASILOXANE▪KAOLIN▪DIPHENYLSILOXY PHENYL TRIMETHICONE▪PARAFFIN▪LITHIUM MAGNESIUM SODIUM SILICATE▪DIISOSTEARYL MALATE▪POLYETHYLENE▪SORBITAN SESQUIISOSTEARATE▪GLYCERIN▪BARIUM SULFATE▪COPERNICIA CERIFERA (CARNAUBA) WAX▪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▪WATER▪ALUMINUM HYDROXIDE▪STEARIC ACID▪ALUMINA▪SYNTHETIC FLUORPHLOGOPITE▪BUTYLENE GLYCOL▪TOCOPHEROL▪ALCOHOL▪SIMETHICONE▪TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE▪DIMETHICONE▪BHT▪FRAGRANCE▪IRON OXIDES▪MICA▪TITANIUM DIOXIDE▪

Other Information

Protect this product in this container from excessive heat and direct sun.

* Please review the disclaimer below.