Shiseido Uv Protective Compact (refill) Light Ivory
Octinoxate, Octocrylene, And Titanium Dioxide
Shiseido Americas Corporation
Human Otc Drug
NDC 58411-123Shiseido Uv Protective Compact (refill) Light Ivory also known as Octinoxate, Octocrylene, And Titanium Dioxide is a human otc drug labeled by 'Shiseido Americas Corporation'. National Drug Code (NDC) number for Shiseido Uv Protective Compact (refill) Light Ivory is 58411-123. This drug is available in dosage form of Powder. The names of the active, medicinal ingredients in Shiseido Uv Protective Compact (refill) Light Ivory drug includes Octinoxate - 888 mg/12g Octocrylene - 600 mg/12g Titanium Dioxide - 1416 mg/12g . The currest status of Shiseido Uv Protective Compact (refill) Light Ivory drug is Active.
Drug Information:
| Drug NDC: | 58411-123 |
| 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: | Shiseido Uv Protective Compact (refill) Light Ivory |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Shiseido Uv Protective Compact (refill) |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | LIGHT IVORY |
| 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, Octocrylene, 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 - 888 mg/12g
OCTOCRYLENE - 600 mg/12g
TITANIUM DIOXIDE - 1416 mg/12g
|
| 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 Feb, 2014 |
| 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
5A68WGF6WM
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 |
|---|
| 58411-123-30 | 1 TRAY in 1 CARTON (58411-123-30) / 12 g in 1 TRAY | 01 Feb, 2014 | 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 7.4% sunscreen octocrylene 5.0% sunscreen titanium dioxide 11.8% sunscreen
Product Elements:
Shiseido uv protective compact (refill) fair ivory octinoxate, octocrylene, and titanium dioxide dimethicone silicon dioxide nylon-12 petrolatum methicone (20 cst) triethylhexanoin peg/ppg-14/7 dimethyl ether .alpha.-tocopherol acetate, dl- saxifraga stolonifera leaf hyaluronate sodium sophora flavescens root aluminum hydroxide water alcohol hydrated silica triethoxycaprylylsilane aluminum distearate butylene glycol glycerin .alpha.-tocopherol butylated hydroxytoluene distearyldimonium chloride syzygium jambos leaf stannic oxide chlorphenesin mica ferric oxide red ferric oxide yellow ferrosoferric oxide zinc oxide octinoxate octinoxate octocrylene octocrylene titanium dioxide titanium dioxide shiseido uv protective compact (refill) light beige octinoxate, octocrylene, and titanium dioxide dimethicone silicon dioxide nylon-12 petrolatum methicone (20 cst) triethylhexanoin peg/ppg-14/7 dimethyl ether .alpha.-tocopherol acetate, dl- saxifraga stolonifera leaf hyaluronate sodium sophora flavescens root aluminum hydroxide water alcohol hydrated silica triethoxycaprylylsilane aluminum distearate butylene glycol glycerin .alpha.-tocopherol butylated hydroxytoluene distearyldimonium chloride syzygium jambos leaf stannic oxide chlorphenesin mica ferric oxide red ferric oxide yellow ferrosoferric oxide zinc oxide octinoxate octinoxate octocrylene octocrylene titanium dioxide titanium dioxide shiseido uv protective compact (refill) light ivory octinoxate, octocrylene, and titanium dioxide dimethicone silicon dioxide nylon-12 petrolatum methicone (20 cst) triethylhexanoin peg/ppg-14/7 dimethyl ether .alpha.-tocopherol acetate, dl- saxifraga stolonifera leaf hyaluronate sodium sophora flavescens root aluminum hydroxide water alcohol hydrated silica triethoxycaprylylsilane aluminum distearate butylene glycol glycerin .alpha.-tocopherol butylated hydroxytoluene distearyldimonium chloride syzygium jambos leaf stannic oxide chlorphenesin mica ferric oxide red ferric oxide yellow ferrosoferric oxide zinc oxide octinoxate octinoxate octocrylene octocrylene titanium dioxide titanium dioxide shiseido uv protective compact (refill) light ochre octinoxate, octocrylene, and titanium dioxide dimethicone silicon dioxide nylon-12 petrolatum methicone (20 cst) triethylhexanoin peg/ppg-14/7 dimethyl ether .alpha.-tocopherol acetate, dl- saxifraga stolonifera leaf hyaluronate sodium sophora flavescens root aluminum hydroxide water alcohol hydrated silica triethoxycaprylylsilane aluminum distearate butylene glycol glycerin .alpha.-tocopherol butylated hydroxytoluene distearyldimonium chloride syzygium jambos leaf stannic oxide chlorphenesin mica ferric oxide red ferric oxide yellow ferrosoferric oxide zinc oxide octinoxate octinoxate octocrylene octocrylene titanium dioxide titanium dioxide shiseido uv protective compact (refill) medium beige octinoxate, octocrylene, and titanium dioxide dimethicone silicon dioxide nylon-12 petrolatum methicone (20 cst) triethylhexanoin peg/ppg-14/7 dimethyl ether .alpha.-tocopherol acetate, dl- saxifraga stolonifera leaf hyaluronate sodium sophora flavescens root aluminum hydroxide water alcohol hydrated silica triethoxycaprylylsilane aluminum distearate butylene glycol glycerin .alpha.-tocopherol butylated hydroxytoluene distearyldimonium chloride syzygium jambos leaf stannic oxide chlorphenesin mica ferric oxide red ferric oxide yellow ferrosoferric oxide zinc oxide octinoxate octinoxate octocrylene octocrylene titanium dioxide titanium dioxide shiseido uv protective compact (refill) medium ivory octinoxate, octocrylene, and titanium dioxide dimethicone silicon dioxide nylon-12 petrolatum methicone (20 cst) triethylhexanoin peg/ppg-14/7 dimethyl ether .alpha.-tocopherol acetate, dl- saxifraga stolonifera leaf hyaluronate sodium sophora flavescens root aluminum hydroxide water alcohol hydrated silica triethoxycaprylylsilane aluminum distearate butylene glycol glycerin .alpha.-tocopherol butylated hydroxytoluene distearyldimonium chloride syzygium jambos leaf stannic oxide chlorphenesin mica ferric oxide red ferric oxide yellow ferrosoferric oxide zinc oxide octinoxate octinoxate octocrylene octocrylene titanium dioxide titanium dioxide shiseido uv protective compact (refill) medium ochre octinoxate, octocrylene, and titanium dioxide dimethicone silicon dioxide nylon-12 petrolatum methicone (20 cst) triethylhexanoin peg/ppg-14/7 dimethyl ether .alpha.-tocopherol acetate, dl- saxifraga stolonifera leaf hyaluronate sodium sophora flavescens root aluminum hydroxide water alcohol hydrated silica triethoxycaprylylsilane aluminum distearate butylene glycol glycerin .alpha.-tocopherol butylated hydroxytoluene distearyldimonium chloride syzygium jambos leaf stannic oxide chlorphenesin mica ferric oxide red ferric oxide yellow ferrosoferric oxide zinc oxide octinoxate octinoxate octocrylene octocrylene titanium dioxide titanium dioxide shiseido uv protective compact (refill) dark beige octinoxate, octocrylene, and titanium dioxide dimethicone silicon dioxide nylon-12 petrolatum methicone (20 cst) triethylhexanoin peg/ppg-14/7 dimethyl ether .alpha.-tocopherol acetate, dl- saxifraga stolonifera leaf hyaluronate sodium sophora flavescens root aluminum hydroxide water alcohol hydrated silica triethoxycaprylylsilane aluminum distearate butylene glycol glycerin .alpha.-tocopherol butylated hydroxytoluene distearyldimonium chloride syzygium jambos leaf stannic oxide chlorphenesin mica ferric oxide red ferric oxide yellow ferrosoferric oxide zinc oxide octinoxate octinoxate octocrylene octocrylene titanium dioxide titanium dioxide shiseido uv protective compact (refill) dark ivory octinoxate, octocrylene, and titanium dioxide dimethicone silicon dioxide nylon-12 petrolatum methicone (20 cst) triethylhexanoin peg/ppg-14/7 dimethyl ether .alpha.-tocopherol acetate, dl- saxifraga stolonifera leaf hyaluronate sodium sophora flavescens root aluminum hydroxide water alcohol hydrated silica triethoxycaprylylsilane aluminum distearate butylene glycol glycerin .alpha.-tocopherol butylated hydroxytoluene distearyldimonium chloride syzygium jambos leaf stannic oxide chlorphenesin mica ferric oxide red ferric oxide yellow ferrosoferric oxide zinc oxide octinoxate octinoxate octocrylene octocrylene titanium dioxide titanium dioxide
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 - 12 g tray carton - fair ivory s hi s eido anti-aging foundation 36 uv protective compact foundation (refill) broad spectrum spf 36 sunscreen 12g net wt. .42 oz. principal display panel - 12 g tray carton - fair ivory
Principal display panel - 12 g tray carton - light beige s hi s eido anti-aging foundation 36 uv protective compact foundation (refill) broad spectrum spf 36 sunscreen 12g net wt. .42 oz. principal display panel - 12 g tray carton - light beige
Principal display panel - 12 g tray carton - light ivory s hi s eido anti-aging foundation 36 uv protective compact foundation (refill) broad spectrum spf 36 sunscreen 12g net wt. .42 oz. principal display panel - 12 g tray carton - light ivory
Principal display panel - 12 g tray carton - light ochre s hi s eido anti-aging foundation 36 uv protective compact foundation (refill) broad spectrum spf 36 sunscreen 12g net wt. .42 oz. principal display panel - 12 g tray carton - light ochre
Principal display panel - 12 g tray carton - medium beige s hi s eido anti-aging foundation 36 uv protective compact foundation (refill) broad spectrum spf 36 sunscreen 12g net wt. .42 oz. principal display panel - 12 g tray carton - medium beige
Principal display panel - 12 g tray carton - medium ivory s hi s eido anti-aging foundation 36 uv protective compact foundation (refill) broad spectrum spf 36 sunscreen 12g net wt. .42 oz. principal display panel - 12 g tray carton - medium ivory
Principal display panel - 12 g tray carton - medium ochre s hi s eido anti-aging foundation 36 uv protective compact foundation (refill) broad spectrum spf 36 sunscreen 12g net wt. .42 oz. principal display panel - 12 g tray carton - medium ochre
Principal display panel - 12 g tray carton - dark beige s hi s eido anti-aging foundation 36 uv protective compact foundation (refill) broad spectrum spf 36 sunscreen 12g net wt. .42 oz. principal display panel - 12 g tray carton - dark beige
Principal display panel - 12 g tray carton - dark ivory s hi s eido anti-aging foundation 36 uv protective compact foundation (refill) broad spectrum spf 36 sunscreen 12g net wt. .42 oz. principal display panel - 12 g tray carton - dark ivory
Further Questions:
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