NDC 52685-367 Cle De Peau Beaute Pw Foundation S O20

Product Information

What is NDC 52685-367?

The NDC code 52685-367 is assigned by the FDA to the UNFINISHED product Cle De Peau Beaute Pw Foundation S O20 which is product labeled by Shiseido Co., Ltd.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 52685-367-30 1 tray in 1 carton / 11 g in 1 tray. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code	52685-367
Proprietary Name 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.	Cle De Peau Beaute Pw Foundation S O20
Product Labeler Information What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.	Shiseido Co., Ltd.
Labeler Code	52685
Start Marketing Date What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.	09-01-2009
Listing Expiration Date 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.	12-31-2018
Exclude Flag 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".	I
Unfinished Product What is an Unfinished Product? Not Available	Yes
NDC Code Structure	52685 - Shiseido Co., Ltd. 52685-367 - Cle De Peau Beaute Pw Foundation S 52685-367-30

What are the uses for Cle De Peau Beaute Pw Foundation S O20?

This product is used as Active ingredientsPurposeOCTINOXATE1.9%SunscreenTITANIUM DIOXIDE3.3%Sunscreen

Product Packages

NDC Code 52685-367-30

Package Description: 1 TRAY in 1 CARTON / 11 g in 1 TRAY

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Product Details

Cle De Peau Beaute Pw Foundation S O20 Active Ingredients UNII Codes

OCTINOXATE (UNII: 4Y5P7MUD51)
OCTINOXATE (UNII: 4Y5P7MUD51) (Active Moiety)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (Active Moiety)

Cle De Peau Beaute Pw Foundation S O20 Inactive Ingredients UNII Codes

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.

TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE (UNII: 92RU3N3Y1O)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHICONE (20 CST) (UNII: 6777U11MKT)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

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Cle De Peau Beaute Pw Foundation S O20 Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents

Other

Drug Facts

Manufactured by SHISEIDO CO., LTD. 7-5-5 GINZA TOKYO

Otc - Purpose

Active ingredients		Purpose
OCTINOXATE	1.9%	Sunscreen
TITANIUM DIOXIDE	3.3%	Sunscreen

Use

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

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 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 Ingredients

TALC, SYNTHETIC FLUORPHLOGOPITE, BARIUM SULFATE∙ DIMETHICONE, TRIETHYLHEXANOIN, BIS-BEHENYL/PHYTOSTERYL DIMER DILINOLEATE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, SILICA, NYLON-12, SILICA DIMETHYL SILYLATE, TOCOPHERYL ACETATE, PRUNUS SPECIOSA LEAF EXTRACT∙ SODIUM ACETYLATED HYALURONATE, ROSA ROXBURGHII FRUIT EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, SORBITAN SESQUIISOSTEARATE, TRIETHOXYSILYLETHYL, POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, METHICONE, ALUMINUM HYDROXIDE, ALUMINUM DISTEARATE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE, SODIUM MAGNESIUM SILICATE, POLYSILICONE-2, GLYCERIN, TOCOPHEROL, WATER, BUTYLENE GLYCOL, ALCOHOL, BHT, CHLORPHENESIN, FRAGRANCE, TITANIUM DIOXIDE, MICA, ZINC OXIDE, IRON OXIDES

Other Information

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

PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - B30 - cle de peau 08

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