Cle De Peau Beaute Radiant Foundation O40
Octinoxate And Titanium Dioxide
Shiseido Americas Corporation
Human Otc Drug
NDC 58411-245Cle De Peau Beaute Radiant Foundation O40 also known as Octinoxate And Titanium Dioxide is a human otc drug labeled by 'Shiseido Americas Corporation'. National Drug Code (NDC) number for Cle De Peau Beaute Radiant Foundation O40 is 58411-245. This drug is available in dosage form of Powder. The names of the active, medicinal ingredients in Cle De Peau Beaute Radiant Foundation O40 drug includes Octinoxate - 319 mg/11g Titanium Dioxide - 363 mg/11g . The currest status of Cle De Peau Beaute Radiant Foundation O40 drug is Active.
Drug Information:
| Drug NDC: | 58411-245 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Cle De Peau Beaute Radiant Foundation O40 |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Cle De Peau Beaute Radiant Foundation |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | O40 |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Octinoxate And Titanium Dioxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Shiseido Americas Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Powder |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | OCTINOXATE - 319 mg/11g
TITANIUM DIOXIDE - 363 mg/11g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 01 Mar, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part352 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | SHISEIDO AMERICAS CORPORATION
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 4Y5P7MUD51
15FIX9V2JP
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 58411-245-30 | 1 TRAY in 1 CARTON (58411-245-30) / 11 g in 1 TRAY | 01 Mar, 2015 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Active ingredients purpose octinoxate 2.9% sunscreen titanium dioxide 3.3% sunscreen
Product Elements:
Cle de peau beaute radiant foundation i10 octinoxate and titanium dioxide octinoxate octinoxate titanium dioxide titanium dioxide talc barium sulfate zinc oxide triethylhexanoin dimethicone silicon dioxide nylon-12 calcium aluminum borosilicate diphenylsiloxy phenyl trimethicone hydrogenated polybutene (1300 mw) rosa roxburghii fruit sodium acetylated hyaluronate aluminum hydroxide aluminum distearate methicone (20 cst) magnesium myristate butylene glycol water glycerin .alpha.-tocopherol butylated hydroxytoluene polymethylsilsesquioxane (4.5 microns) aluminum oxide chlorphenesin mica bismuth oxychloride ferric oxide red ferric oxide yellow ferrosoferric oxide cle de peau beaute radiant foundation o10 octinoxate and titanium dioxide octinoxate octinoxate titanium dioxide titanium dioxide talc barium sulfate zinc oxide triethylhexanoin dimethicone silicon dioxide nylon-12 calcium aluminum borosilicate diphenylsiloxy phenyl trimethicone hydrogenated polybutene (1300 mw) rosa roxburghii fruit sodium acetylated hyaluronate aluminum hydroxide aluminum distearate methicone (20 cst) magnesium myristate butylene glycol water glycerin .alpha.-tocopherol butylated hydroxytoluene polymethylsilsesquioxane (4.5 microns) aluminum oxide chlorphenesin mica bismuth oxychloride ferric oxide red ferric oxide yellow ferrosoferric oxide cle de peau beaute radiant foundation o20 octinoxate and titanium dioxide octinoxate octinoxate titanium dioxide titanium dioxide talc barium sulfate zinc oxide triethylhexanoin dimethicone silicon dioxide nylon-12 calcium aluminum borosilicate diphenylsiloxy phenyl trimethicone hydrogenated polybutene (1300 mw) rosa roxburghii fruit sodium acetylated hyaluronate aluminum hydroxide aluminum distearate methicone (20 cst) magnesium myristate butylene glycol water glycerin .alpha.-tocopherol butylated hydroxytoluene polymethylsilsesquioxane (4.5 microns) aluminum oxide chlorphenesin mica bismuth oxychloride ferric oxide red ferric oxide yellow ferrosoferric oxide cle de peau beaute radiant foundation o30 octinoxate and titanium dioxide octinoxate octinoxate titanium dioxide titanium dioxide talc barium sulfate zinc oxide triethylhexanoin dimethicone silicon dioxide nylon-12 calcium aluminum borosilicate diphenylsiloxy phenyl trimethicone hydrogenated polybutene (1300 mw) rosa roxburghii fruit sodium acetylated hyaluronate aluminum hydroxide aluminum distearate methicone (20 cst) magnesium myristate butylene glycol water glycerin .alpha.-tocopherol butylated hydroxytoluene polymethylsilsesquioxane (4.5 microns) aluminum oxide chlorphenesin mica bismuth oxychloride ferric oxide red ferric oxide yellow ferrosoferric oxide cle de peau beaute radiant foundation o40 octinoxate and titanium dioxide octinoxate octinoxate titanium dioxide titanium dioxide talc barium sulfate zinc oxide triethylhexanoin dimethicone silicon dioxide nylon-12 calcium aluminum borosilicate diphenylsiloxy phenyl trimethicone hydrogenated polybutene (1300 mw) rosa roxburghii fruit sodium acetylated hyaluronate aluminum hydroxide aluminum distearate methicone (20 cst) magnesium myristate butylene glycol water glycerin .alpha.-tocopherol butylated hydroxytoluene polymethylsilsesquioxane (4.5 microns) aluminum oxide chlorphenesin mica bismuth oxychloride ferric oxide red ferric oxide yellow ferrosoferric oxide cle de peau beaute radiant foundation o50 octinoxate and titanium dioxide octinoxate octinoxate titanium dioxide titanium dioxide talc barium sulfate zinc oxide triethylhexanoin dimethicone silicon dioxide nylon-12 calcium aluminum borosilicate diphenylsiloxy phenyl trimethicone hydrogenated polybutene (1300 mw) rosa roxburghii fruit sodium acetylated hyaluronate aluminum hydroxide aluminum distearate methicone (20 cst) magnesium myristate butylene glycol water glycerin .alpha.-tocopherol butylated hydroxytoluene polymethylsilsesquioxane (4.5 microns) aluminum oxide chlorphenesin mica bismuth oxychloride ferric oxide red ferric oxide yellow ferrosoferric oxide cle de peau beaute radiant foundation o60 octinoxate and titanium dioxide octinoxate octinoxate titanium dioxide titanium dioxide talc barium sulfate zinc oxide triethylhexanoin dimethicone silicon dioxide nylon-12 calcium aluminum borosilicate diphenylsiloxy phenyl trimethicone hydrogenated polybutene (1300 mw) rosa roxburghii fruit sodium acetylated hyaluronate aluminum hydroxide aluminum distearate methicone (20 cst) magnesium myristate butylene glycol water glycerin .alpha.-tocopherol butylated hydroxytoluene polymethylsilsesquioxane (4.5 microns) aluminum oxide chlorphenesin mica bismuth oxychloride ferric oxide red ferric oxide yellow ferrosoferric oxide cle de peau beaute radiant foundation b10 octinoxate and titanium dioxide octinoxate octinoxate titanium dioxide titanium dioxide talc barium sulfate zinc oxide triethylhexanoin dimethicone silicon dioxide nylon-12 calcium aluminum borosilicate diphenylsiloxy phenyl trimethicone hydrogenated polybutene (1300 mw) rosa roxburghii fruit sodium acetylated hyaluronate aluminum hydroxide aluminum distearate methicone (20 cst) magnesium myristate butylene glycol water glycerin .alpha.-tocopherol butylated hydroxytoluene polymethylsilsesquioxane (4.5 microns) aluminum oxide chlorphenesin mica bismuth oxychloride ferric oxide red ferric oxide yellow ferrosoferric oxide cle de peau beaute radiant foundation b20 octinoxate and titanium dioxide octinoxate octinoxate titanium dioxide titanium dioxide talc barium sulfate zinc oxide triethylhexanoin dimethicone silicon dioxide nylon-12 calcium aluminum borosilicate diphenylsiloxy phenyl trimethicone hydrogenated polybutene (1300 mw) rosa roxburghii fruit sodium acetylated hyaluronate aluminum hydroxide aluminum distearate methicone (20 cst) magnesium myristate butylene glycol water glycerin .alpha.-tocopherol butylated hydroxytoluene polymethylsilsesquioxane (4.5 microns) aluminum oxide chlorphenesin mica bismuth oxychloride ferric oxide red ferric oxide yellow ferrosoferric oxide cle de peau beaute radiant foundation b30 octinoxate and titanium dioxide octinoxate octinoxate titanium dioxide titanium dioxide talc barium sulfate zinc oxide triethylhexanoin dimethicone silicon dioxide nylon-12 calcium aluminum borosilicate diphenylsiloxy phenyl trimethicone hydrogenated polybutene (1300 mw) rosa roxburghii fruit sodium acetylated hyaluronate aluminum hydroxide aluminum distearate methicone (20 cst) magnesium myristate butylene glycol water glycerin .alpha.-tocopherol butylated hydroxytoluene polymethylsilsesquioxane (4.5 microns) aluminum oxide chlorphenesin mica bismuth oxychloride ferric oxide red ferric oxide yellow ferrosoferric oxide cle de peau beaute radiant foundation bf20 octinoxate and titanium dioxide octinoxate octinoxate titanium dioxide titanium dioxide talc barium sulfate zinc oxide triethylhexanoin dimethicone silicon dioxide nylon-12 calcium aluminum borosilicate diphenylsiloxy phenyl trimethicone hydrogenated polybutene (1300 mw) rosa roxburghii fruit sodium acetylated hyaluronate aluminum hydroxide aluminum distearate methicone (20 cst) magnesium myristate butylene glycol water glycerin .alpha.-tocopherol butylated hydroxytoluene polymethylsilsesquioxane (4.5 microns) aluminum oxide chlorphenesin mica bismuth oxychloride ferric oxide red ferric oxide yellow ferrosoferric oxide cle de peau beaute radiant foundation wb20 octinoxate and titanium dioxide octinoxate octinoxate titanium dioxide titanium dioxide talc barium sulfate zinc oxide triethylhexanoin dimethicone silicon dioxide nylon-12 calcium aluminum borosilicate diphenylsiloxy phenyl trimethicone hydrogenated polybutene (1300 mw) rosa roxburghii fruit sodium acetylated hyaluronate aluminum hydroxide aluminum distearate methicone (20 cst) magnesium myristate butylene glycol water glycerin .alpha.-tocopherol butylated hydroxytoluene polymethylsilsesquioxane (4.5 microns) aluminum oxide chlorphenesin mica bismuth oxychloride ferric oxide red ferric oxide yellow ferrosoferric oxide
Indications and Usage:
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
Warnings:
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.
Do Not Use:
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.
When Using:
When using this product keep out of eyes. rinse with water to remove.
Dosage and Administration:
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. â 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses children under 6 months: ask a doctor
Stop Use:
Stop use and ask a doctor if rash occurs
Package Label Principal Display Panel:
Principal display panel - 11 g tray carton - i10 clé de peau beautà radiant powder foundation broad spectrum spf 23 sunscreen 11g net wt. .38 oz. principal display panel - 11 g tray carton - i10
Principal display panel - 11 g tray carton - o10 clé de peau beautà radiant powder foundation broad spectrum spf 23 sunscreen 11g net wt. .38 oz. principal display panel - 11 g tray carton - o10
Principal display panel - 11 g tray carton - o20 clé de peau beautà radiant powder foundation broad spectrum spf 23 sunscreen 11g net wt. .38 oz. principal display panel - 11 g tray carton - o20
Principal display panel - 11 g tray carton - o30 clé de peau beautà radiant powder foundation broad spectrum spf 23 sunscreen 11g net wt. .38 oz. principal display panel - 11 g tray carton - o30
Principal display panel - 11 g tray carton - o40 clé de peau beautà radiant powder foundation broad spectrum spf 23 sunscreen 11g net wt. .38 oz. principal display panel - 11 g tray carton - o40
Principal display panel - 11 g tray carton - o50 clé de peau beautà radiant powder foundation broad spectrum spf 23 sunscreen 11g net wt. .38 oz. principal display panel - 11 g tray carton - o50
Principal display panel - 11 g tray carton - o60 clé de peau beautà radiant powder foundation broad spectrum spf 23 sunscreen 11g net wt. .38 oz. principal display panel - 11 g tray carton - o60
Principal display panel - 11 g tray carton - b10 clé de peau beautà radiant powder foundation broad spectrum spf 23 sunscreen 11g net wt. .38 oz. principal display panel - 11 g tray carton - b10
Principal display panel - 11 g tray carton - b20 clé de peau beautà radiant powder foundation broad spectrum spf 23 sunscreen 11g net wt. .38 oz. principal display panel - 11 g tray carton - b20
Principal display panel - 11 g tray carton - b30 clé de peau beautà radiant powder foundation broad spectrum spf 23 sunscreen 11g net wt. .38 oz. principal display panel - 11 g tray carton - b30
Principal display panel - 11 g tray carton - bf20 clé de peau beautà radiant powder foundation broad spectrum spf 23 sunscreen 11g net wt. .38 oz. principal display panel - 11 g tray carton - bf20
Principal display panel - 11 g tray carton - wb20 clé de peau beautà radiant powder foundation broad spectrum spf 23 sunscreen 11g net wt. .38 oz. principal display panel - 11 g tray carton - wb20
Further Questions:
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