NDC 52685-436 Shiseido The Makeup Perfect Smoothing Compact Foundation (refill) I60

Octinoxate And Titanium Dioxide

NDC Product Code 52685-436

NDC CODE: 52685-436

Proprietary Name: Shiseido The Makeup Perfect Smoothing Compact Foundation (refill) I60 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Octinoxate And Titanium Dioxide What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 52685 - Shiseido Co., Ltd.
    • 52685-436 - Shiseido The Makeup Perfect Smoothing Compact Foundation (refill)

NDC 52685-436-30

Package Description: 1 TRAY in 1 CARTON > 10 g in 1 TRAY

NDC Product Information

Shiseido The Makeup Perfect Smoothing Compact Foundation (refill) I60 with NDC 52685-436 is a a human over the counter drug product labeled by Shiseido Co., Ltd.. The generic name of Shiseido The Makeup Perfect Smoothing Compact Foundation (refill) I60 is octinoxate and titanium dioxide. The product's dosage form is powder and is administered via topical form.

Dosage Form: Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

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.

Shiseido The Makeup Perfect Smoothing Compact Foundation (refill) I60 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.


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.

  • BARIUM SULFATE (UNII: 25BB7EKE2E)
  • TALC (UNII: 7SEV7J4R1U)
  • MICA (UNII: V8A1AW0880)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • ZINC MYRISTATE (UNII: K09A9E2GGO)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • BORON NITRIDE (UNII: 2U4T60A6YD)
  • DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • SQUALANE (UNII: GW89575KF9)
  • ZINC OXIDE (UNII: SOI2LOH54Z)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • ROYAL JELLY (UNII: L497I37F0C)
  • BARIUM SULFATE (UNII: 25BB7EKE2E)
  • TALC (UNII: 7SEV7J4R1U)
  • MICA (UNII: V8A1AW0880)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • ZINC MYRISTATE (UNII: K09A9E2GGO)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • BORON NITRIDE (UNII: 2U4T60A6YD)
  • DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • SQUALANE (UNII: GW89575KF9)
  • ZINC OXIDE (UNII: SOI2LOH54Z)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • ROYAL JELLY (UNII: L497I37F0C)
  • BARIUM SULFATE (UNII: 25BB7EKE2E)
  • TALC (UNII: 7SEV7J4R1U)
  • MICA (UNII: V8A1AW0880)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • ZINC MYRISTATE (UNII: K09A9E2GGO)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • BORON NITRIDE (UNII: 2U4T60A6YD)
  • DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • SQUALANE (UNII: GW89575KF9)
  • ZINC OXIDE (UNII: SOI2LOH54Z)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • ROYAL JELLY (UNII: L497I37F0C)
  • BARIUM SULFATE (UNII: 25BB7EKE2E)
  • TALC (UNII: 7SEV7J4R1U)
  • MICA (UNII: V8A1AW0880)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • ZINC MYRISTATE (UNII: K09A9E2GGO)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • BORON NITRIDE (UNII: 2U4T60A6YD)
  • DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • SQUALANE (UNII: GW89575KF9)
  • ZINC OXIDE (UNII: SOI2LOH54Z)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • ROYAL JELLY (UNII: L497I37F0C)

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 Co., Ltd.
Labeler Code: 52685
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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 09-01-2008 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Shiseido The Makeup Perfect Smoothing Compact Foundation (refill) I60 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

Manufactured bySHISEIDO CO., LTD. 7-5-5 GINZA TOKYO

Otc - Purpose

Active ingredientsPurposeOCTINOXATE 1.4%SunscreenTITANIUM DIOXIDE 2.5%Sunscreen

Use

  • Helps prevent sunburn

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 2 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

BARIUM SULFATE • TALC • TITANIUM DIOXIDE • MICA • VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER • SYNTHETIC FLUORPHLOGOPITE • IRON OXIDES • ZINC MYRISTATE • DIMETHICONE • BORON NITRIDE • DIISOSTEARYL MALATE • PETROLATUM • SQUALANE • ZINC OXIDE • SORBITAN SESQUIISOSTEARATE • POLYSILICONE-2 • ALUMINUM HYDROXIDE • ALUMINUM DISTEARATE • ETHYLHEXYLGLYCERIN • PEG/PPG-36/41 DIMETHYL ETHER • ALCOHOL • WATER • TOCOPHEROL • POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE • FRAGRANCE • PHENOXYETHANOL • ALUMINA • BHT • ROYAL JELLY EXTRACT

Other Information

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

* Please review the disclaimer below.