Shiseido Synchro Skin Self-refreshing Tint 125 Fair Asterid
Octinoxate, Octocrylene, And Titanium Dioxide
Shiseido Americas Corporation
Human Otc Drug
NDC 58411-674Shiseido Synchro Skin Self-refreshing Tint 125 Fair Asterid 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 Synchro Skin Self-refreshing Tint 125 Fair Asterid is 58411-674. This drug is available in dosage form of Emulsion. The names of the active, medicinal ingredients in Shiseido Synchro Skin Self-refreshing Tint 125 Fair Asterid drug includes Octinoxate - 2010 mg/30mL Octocrylene - 900 mg/30mL Titanium Dioxide - 600 mg/30mL . The currest status of Shiseido Synchro Skin Self-refreshing Tint 125 Fair Asterid drug is Active.
Drug Information:
| Drug NDC: | 58411-674 |
| 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 Synchro Skin Self-refreshing Tint 125 Fair Asterid |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Shiseido Synchro Skin Self-refreshing Tint |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | 125 Fair Asterid |
| 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: | Emulsion |
| 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 - 2010 mg/30mL
OCTOCRYLENE - 900 mg/30mL
TITANIUM DIOXIDE - 600 mg/30mL
|
| 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: | 16 Dec, 2019 |
| 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 |
|---|
| 58411-674-20 | 1 TUBE in 1 CONTAINER (58411-674-20) / 30 mL in 1 TUBE | 16 Dec, 2019 | 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 4.7% sunscreen octocrylene 3.0% sunscreen titanium dioxide 2.0% sunscreen
Product Elements:
Shiseido synchro skin self-refreshing tint 115 fair shirakaba octinoxate, octocrylene, and titanium dioxide octinoxate octinoxate octocrylene octocrylene titanium dioxide titanium dioxide water dimethicone glycerin caprylyl trisiloxane butylene glycol ferric oxide yellow ferric oxide red ferrosoferric oxide dimethicone/peg-10/15 crosspolymer sodium chloride magnesium potassium aluminosilicate fluoride sorbitan sesquiisostearate phenoxyethanol disteardimonium hectorite peg-10 dimethicone (600 cst) aluminum hydroxide stearic acid edetate trisodium laponite squalane sodium citrate, unspecified form dipropylene glycol polysorbate 60 isododecane peg/ppg-19/19 dimethicone hydrogenated polybutene (1300 mw) butylated hydroxytoluene mica tocopherol sorbitan isostearate thymus serpyllum whole polymethylsilsesquioxane (4.5 microns) dimethicone/vinyl dimethicone crosspolymer (soft particle) polyquaternium-51 (2-methacryloyloxyethyl phosphorylcholine/n-butyl methacrylate; 3:7) hyaluronate sodium shiseido synchro skin self-refreshing tint 125 fair asterid octinoxate, octocrylene, and titanium dioxide octinoxate octinoxate octocrylene octocrylene titanium dioxide titanium dioxide water dimethicone glycerin caprylyl trisiloxane butylene glycol ferric oxide yellow ferric oxide red ferrosoferric oxide dimethicone/peg-10/15 crosspolymer sodium chloride magnesium potassium aluminosilicate fluoride sorbitan sesquiisostearate phenoxyethanol disteardimonium hectorite peg-10 dimethicone (600 cst) aluminum hydroxide stearic acid edetate trisodium laponite squalane sodium citrate, unspecified form dipropylene glycol polysorbate 60 isododecane peg/ppg-19/19 dimethicone hydrogenated polybutene (1300 mw) butylated hydroxytoluene mica tocopherol sorbitan isostearate thymus serpyllum whole polymethylsilsesquioxane (4.5 microns) dimethicone/vinyl dimethicone crosspolymer (soft particle) polyquaternium-51 (2-methacryloyloxyethyl phosphorylcholine/n-butyl methacrylate; 3:7) hyaluronate sodium shiseido synchro skin self-refreshing tint 215 light buna octinoxate, octocrylene, and titanium dioxide octinoxate octinoxate octocrylene octocrylene titanium dioxide titanium dioxide water dimethicone glycerin caprylyl trisiloxane butylene glycol ferric oxide yellow ferric oxide red ferrosoferric oxide dimethicone/peg-10/15 crosspolymer sodium chloride magnesium potassium aluminosilicate fluoride sorbitan sesquiisostearate phenoxyethanol disteardimonium hectorite peg-10 dimethicone (600 cst) aluminum hydroxide stearic acid edetate trisodium laponite squalane sodium citrate, unspecified form dipropylene glycol polysorbate 60 isododecane peg/ppg-19/19 dimethicone hydrogenated polybutene (1300 mw) butylated hydroxytoluene mica tocopherol sorbitan isostearate thymus serpyllum whole polymethylsilsesquioxane (4.5 microns) dimethicone/vinyl dimethicone crosspolymer (soft particle) polyquaternium-51 (2-methacryloyloxyethyl phosphorylcholine/n-butyl methacrylate; 3:7) hyaluronate sodium shiseido synchro skin self-refreshing tint 225 light magnolia octinoxate, octocrylene, and titanium dioxide octinoxate octinoxate octocrylene octocrylene titanium dioxide titanium dioxide water dimethicone glycerin caprylyl trisiloxane butylene glycol ferric oxide yellow ferric oxide red ferrosoferric oxide dimethicone/peg-10/15 crosspolymer sodium chloride magnesium potassium aluminosilicate fluoride sorbitan sesquiisostearate phenoxyethanol disteardimonium hectorite peg-10 dimethicone (600 cst) aluminum hydroxide stearic acid edetate trisodium laponite squalane sodium citrate, unspecified form dipropylene glycol polysorbate 60 isododecane peg/ppg-19/19 dimethicone hydrogenated polybutene (1300 mw) butylated hydroxytoluene mica tocopherol sorbitan isostearate thymus serpyllum whole polymethylsilsesquioxane (4.5 microns) dimethicone/vinyl dimethicone crosspolymer (soft particle) polyquaternium-51 (2-methacryloyloxyethyl phosphorylcholine/n-butyl methacrylate; 3:7) hyaluronate sodium shiseido synchro skin self-refreshing tint 235 light hiba octinoxate, octocrylene, and titanium dioxide octinoxate octinoxate octocrylene octocrylene titanium dioxide titanium dioxide water dimethicone glycerin caprylyl trisiloxane butylene glycol ferric oxide yellow ferric oxide red ferrosoferric oxide dimethicone/peg-10/15 crosspolymer sodium chloride magnesium potassium aluminosilicate fluoride sorbitan sesquiisostearate phenoxyethanol disteardimonium hectorite peg-10 dimethicone (600 cst) aluminum hydroxide stearic acid edetate trisodium laponite squalane sodium citrate, unspecified form dipropylene glycol polysorbate 60 isododecane peg/ppg-19/19 dimethicone hydrogenated polybutene (1300 mw) butylated hydroxytoluene mica tocopherol sorbitan isostearate thymus serpyllum whole polymethylsilsesquioxane (4.5 microns) dimethicone/vinyl dimethicone crosspolymer (soft particle) polyquaternium-51 (2-methacryloyloxyethyl phosphorylcholine/n-butyl methacrylate; 3:7) hyaluronate sodium shiseido synchro skin self-refreshing tint 315 medium matsu octinoxate, octocrylene, and titanium dioxide octinoxate octinoxate octocrylene octocrylene titanium dioxide titanium dioxide water dimethicone glycerin caprylyl trisiloxane butylene glycol ferric oxide yellow ferric oxide red ferrosoferric oxide dimethicone/peg-10/15 crosspolymer sodium chloride magnesium potassium aluminosilicate fluoride sorbitan sesquiisostearate phenoxyethanol disteardimonium hectorite peg-10 dimethicone (600 cst) aluminum hydroxide stearic acid edetate trisodium laponite squalane sodium citrate, unspecified form dipropylene glycol polysorbate 60 isododecane peg/ppg-19/19 dimethicone hydrogenated polybutene (1300 mw) butylated hydroxytoluene mica tocopherol sorbitan isostearate thymus serpyllum whole polymethylsilsesquioxane (4.5 microns) dimethicone/vinyl dimethicone crosspolymer (soft particle) polyquaternium-51 (2-methacryloyloxyethyl phosphorylcholine/n-butyl methacrylate; 3:7) hyaluronate sodium shiseido synchro skin self-refreshing tint 325 medium keyaki octinoxate, octocrylene, and titanium dioxide octinoxate octinoxate octocrylene octocrylene titanium dioxide titanium dioxide water dimethicone glycerin caprylyl trisiloxane butylene glycol ferric oxide yellow ferric oxide red ferrosoferric oxide dimethicone/peg-10/15 crosspolymer sodium chloride magnesium potassium aluminosilicate fluoride sorbitan sesquiisostearate phenoxyethanol disteardimonium hectorite peg-10 dimethicone (600 cst) aluminum hydroxide stearic acid edetate trisodium laponite squalane sodium citrate, unspecified form dipropylene glycol polysorbate 60 isododecane peg/ppg-19/19 dimethicone hydrogenated polybutene (1300 mw) butylated hydroxytoluene mica tocopherol sorbitan isostearate thymus serpyllum whole polymethylsilsesquioxane (4.5 microns) dimethicone/vinyl dimethicone crosspolymer (soft particle) polyquaternium-51 (2-methacryloyloxyethyl phosphorylcholine/n-butyl methacrylate; 3:7) hyaluronate sodium shiseido synchro skin self-refreshing tint 335 medium katsura octinoxate, octocrylene, and titanium dioxide octinoxate octinoxate octocrylene octocrylene titanium dioxide titanium dioxide water dimethicone glycerin caprylyl trisiloxane butylene glycol ferric oxide yellow ferric oxide red ferrosoferric oxide dimethicone/peg-10/15 crosspolymer sodium chloride magnesium potassium aluminosilicate fluoride sorbitan sesquiisostearate phenoxyethanol disteardimonium hectorite peg-10 dimethicone (600 cst) aluminum hydroxide stearic acid edetate trisodium laponite squalane sodium citrate, unspecified form dipropylene glycol polysorbate 60 isododecane peg/ppg-19/19 dimethicone hydrogenated polybutene (1300 mw) butylated hydroxytoluene mica tocopherol sorbitan isostearate thymus serpyllum whole polymethylsilsesquioxane (4.5 microns) dimethicone/vinyl dimethicone crosspolymer (soft particle) polyquaternium-51 (2-methacryloyloxyethyl phosphorylcholine/n-butyl methacrylate; 3:7) hyaluronate sodium shiseido synchro skin self-refreshing tint 415 tan kwanzan octinoxate, octocrylene, and titanium dioxide octinoxate octinoxate octocrylene octocrylene titanium dioxide titanium dioxide water dimethicone glycerin caprylyl trisiloxane butylene glycol ferric oxide yellow ferric oxide red ferrosoferric oxide dimethicone/peg-10/15 crosspolymer sodium chloride magnesium potassium aluminosilicate fluoride sorbitan sesquiisostearate phenoxyethanol disteardimonium hectorite peg-10 dimethicone (600 cst) aluminum hydroxide stearic acid edetate trisodium laponite squalane sodium citrate, unspecified form dipropylene glycol polysorbate 60 isododecane peg/ppg-19/19 dimethicone hydrogenated polybutene (1300 mw) butylated hydroxytoluene mica tocopherol sorbitan isostearate thymus serpyllum whole polymethylsilsesquioxane (4.5 microns) dimethicone/vinyl dimethicone crosspolymer (soft particle) polyquaternium-51 (2-methacryloyloxyethyl phosphorylcholine/n-butyl methacrylate; 3:7) hyaluronate sodium shiseido synchro skin self-refreshing tint 425 tan ume octinoxate, octocrylene, and titanium dioxide octinoxate octinoxate octocrylene octocrylene titanium dioxide titanium dioxide water dimethicone glycerin caprylyl trisiloxane butylene glycol ferric oxide yellow ferric oxide red ferrosoferric oxide dimethicone/peg-10/15 crosspolymer sodium chloride magnesium potassium aluminosilicate fluoride sorbitan sesquiisostearate phenoxyethanol disteardimonium hectorite peg-10 dimethicone (600 cst) aluminum hydroxide stearic acid edetate trisodium laponite squalane sodium citrate, unspecified form dipropylene glycol polysorbate 60 isododecane peg/ppg-19/19 dimethicone hydrogenated polybutene (1300 mw) butylated hydroxytoluene mica tocopherol sorbitan isostearate thymus serpyllum whole polymethylsilsesquioxane (4.5 microns) dimethicone/vinyl dimethicone crosspolymer (soft particle) polyquaternium-51 (2-methacryloyloxyethyl phosphorylcholine/n-butyl methacrylate; 3:7) hyaluronate sodium shiseido synchro skin self-refreshing tint 515 deep tsubaki octinoxate, octocrylene, and titanium dioxide octinoxate octinoxate octocrylene octocrylene titanium dioxide titanium dioxide water dimethicone glycerin caprylyl trisiloxane butylene glycol ferric oxide yellow ferric oxide red ferrosoferric oxide dimethicone/peg-10/15 crosspolymer sodium chloride magnesium potassium aluminosilicate fluoride sorbitan sesquiisostearate phenoxyethanol disteardimonium hectorite peg-10 dimethicone (600 cst) aluminum hydroxide stearic acid edetate trisodium laponite squalane sodium citrate, unspecified form dipropylene glycol polysorbate 60 isododecane peg/ppg-19/19 dimethicone hydrogenated polybutene (1300 mw) butylated hydroxytoluene mica tocopherol sorbitan isostearate thymus serpyllum whole polymethylsilsesquioxane (4.5 microns) dimethicone/vinyl dimethicone crosspolymer (soft particle) polyquaternium-51 (2-methacryloyloxyethyl phosphorylcholine/n-butyl methacrylate; 3:7) hyaluronate sodium shiseido synchro skin self-refreshing tint 525 deep kuromoji octinoxate, octocrylene, and titanium dioxide octinoxate octinoxate octocrylene octocrylene titanium dioxide titanium dioxide water dimethicone glycerin caprylyl trisiloxane butylene glycol ferric oxide yellow ferric oxide red ferrosoferric oxide dimethicone/peg-10/15 crosspolymer sodium chloride magnesium potassium aluminosilicate fluoride sorbitan sesquiisostearate phenoxyethanol disteardimonium hectorite peg-10 dimethicone (600 cst) aluminum hydroxide stearic acid edetate trisodium laponite squalane sodium citrate, unspecified form dipropylene glycol polysorbate 60 isododecane peg/ppg-19/19 dimethicone hydrogenated polybutene (1300 mw) butylated hydroxytoluene mica tocopherol sorbitan isostearate thymus serpyllum whole polymethylsilsesquioxane (4.5 microns) dimethicone/vinyl dimethicone crosspolymer (soft particle) polyquaternium-51 (2-methacryloyloxyethyl phosphorylcholine/n-butyl methacrylate; 3:7) hyaluronate sodium
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. flammable do not use near heat, flame, or while smoking.
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. flammable do not use near heat, flame, or while smoking.
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 children under 6 months: ask a doctor 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 value 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
Stop Use:
Stop use and ask a doctor if rash occurs.
Package Label Principal Display Panel:
Principal display panel - 30 ml bottle carton - 115 fair shirakaba shiseido ginza tokyo synchro skin self-refreshing tint broad spectrum spf 20 sunscreen for face 30ml net wt. .95 oz. principal display panel - 30 ml bottle carton - 115 fair shirakaba
Principal display panel - 30 ml bottle carton - 125 fair asterid shiseido ginza tokyo synchro skin self-refreshing tint broad spectrum spf 20 sunscreen for face 30ml net wt. .95 oz. principal display panel - 30 ml bottle carton - 125 fair asterid
Principal display panel - 30 ml bottle carton - 215 light buna shiseido ginza tokyo synchro skin self-refreshing tint broad spectrum spf 20 sunscreen for face 30ml net wt. .95 oz. principal display panel - 30 ml bottle carton - 215 light buna
Principal display panel - 30 ml bottle carton - 225 light magnolia shiseido ginza tokyo synchro skin self-refreshing tint broad spectrum spf 20 sunscreen for face 30ml net wt. .95 oz. principal display panel - 30 ml bottle carton - 225 light magnolia
Principal display panel - 30 ml bottle carton - 235 light hiba shiseido ginza tokyo synchro skin self-refreshing tint broad spectrum spf 20 sunscreen for face 30ml net wt. .95 oz. principal display panel - 30 ml bottle carton - 235 light hiba
Principal display panel - 30 ml bottle carton - 315 medium matsu shiseido ginza tokyo synchro skin self-refreshing tint broad spectrum spf 20 sunscreen for face 30ml net wt. .95 oz. principal display panel - 30 ml bottle carton - 315 medium matsu
Principal display panel - 30 ml bottle carton - 325 medium keyaki shiseido ginza tokyo synchro skin self-refreshing tint broad spectrum spf 20 sunscreen for face 30ml net wt. .95 oz. principal display panel - 30 ml bottle carton - 325 medium keyaki
Principal display panel - 30 ml bottle carton - 335 medium katsura shiseido ginza tokyo synchro skin self-refreshing tint broad spectrum spf 20 sunscreen for face 30ml net wt. .95 oz. principal display panel - 30 ml bottle carton - 335 medium katsura
Principal display panel - 30 ml bottle carton - 415 tan kwanzan shiseido ginza tokyo synchro skin self-refreshing tint broad spectrum spf 20 sunscreen for face 30ml net wt. .95 oz. principal display panel - 30 ml bottle carton - 415 tan kwanzan
Principal display panel - 30 ml bottle carton - 425 tan ume shiseido ginza tokyo synchro skin self-refreshing tint broad spectrum spf 20 sunscreen for face 30ml net wt. .95 oz. principal display panel - 30 ml bottle carton - 425 tan ume
Principal display panel - 30 ml bottle carton - 515 deep tsubaki shiseido ginza tokyo synchro skin self-refreshing tint broad spectrum spf 20 sunscreen for face 30ml net wt. .95 oz. principal display panel - 30 ml bottle carton - 515 deep tsubaki
Principal display panel - 30 ml bottle carton - 525 deep kuromoji shiseido ginza tokyo synchro skin self-refreshing tint broad spectrum spf 20 sunscreen for face 30ml net wt. .95 oz. principal display panel - 30 ml bottle carton - 525 deep kuromoji
Further Questions:
Questions or comments? call toll free 1-800-906-7503