Shiseido Sun Protection Lip Treatment
Octinoxate And Titanium Dioxide
Shiseido America Inc.
Human Otc Drug
NDC 52686-642Shiseido Sun Protection Lip Treatment also known as Octinoxate And Titanium Dioxide is a human otc drug labeled by 'Shiseido America Inc.'. National Drug Code (NDC) number for Shiseido Sun Protection Lip Treatment is 52686-642. This drug is available in dosage form of Lipstick. The names of the active, medicinal ingredients in Shiseido Sun Protection Lip Treatment drug includes Octinoxate - 296 mg/4g Titanium Dioxide - 180 mg/4g . The currest status of Shiseido Sun Protection Lip Treatment drug is Active.
Drug Information:
| Drug NDC: | 52686-642 |
| 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 Sun Protection Lip Treatment |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| 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 America Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lipstick |
| 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 - 296 mg/4g
TITANIUM DIOXIDE - 180 mg/4g
|
| 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 Oct, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Jun, 2026 |
| 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 AMERICA INC.
|
| 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 |
|---|
| 52686-642-20 | 1 CARTRIDGE in 1 CARTON (52686-642-20) / 4 g in 1 CARTRIDGE | 01 Oct, 2012 | 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 titanium dioxide 4.5% sunscreen
Product Elements:
Shiseido sun protection lip treatment octinoxate and titanium dioxide triethylhexanoin triisostearin hydrogenated polybutene (1300 mw) high density polyethylene peg/ppg-36/41 dimethyl ether microcrystalline wax stearyl glycyrrhetinate glutathione zinc myristate thiotaurine aluminum hydroxide .alpha.-tocopherol diisostearyl malate glycerin butylated hydroxytoluene octinoxate octinoxate titanium dioxide titanium dioxide
Indications and Usage:
Use helps prevent sunburn
Warnings:
Warnings skin cancer/skin aging alert spending time in the sun increases your risk of skin cancer and early skin aging. this product has been shown only to prevent sunburn, not skin cancer or early skin aging. 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 skin cancer/skin aging alert spending time in the sun increases your risk of skin cancer and early skin aging. this product has been shown only to prevent sunburn, not skin cancer or early skin aging. 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 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 - 4g cartridge carton s hi s eido spf 35 sun protection lip treatment sunscreen 4g net wt. .14 oz. principal display panel - 4g cartridge carton
Further Questions:
Questions or comments? call toll free 1-800-906-7503