Thefaceshop Cushion Cc Total Cover Spf 50 Natural Beige
Ensulizole, Titanium Dioxide
Lg Household & Health Care Ltd
Human Otc Drug
NDC 53208-063Thefaceshop Cushion Cc Total Cover Spf 50 Natural Beige also known as Ensulizole, Titanium Dioxide is a human otc drug labeled by 'Lg Household & Health Care Ltd'. National Drug Code (NDC) number for Thefaceshop Cushion Cc Total Cover Spf 50 Natural Beige is 53208-063. This drug is available in dosage form of Powder. The names of the active, medicinal ingredients in Thefaceshop Cushion Cc Total Cover Spf 50 Natural Beige drug includes Ensulizole - .405 g/15g Titanium Dioxide - .819 g/15g . The currest status of Thefaceshop Cushion Cc Total Cover Spf 50 Natural Beige drug is Active.
Drug Information:
| Drug NDC: | 53208-063 |
| 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: | Thefaceshop Cushion Cc Total Cover Spf 50 Natural Beige |
| 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: | Ensulizole, Titanium Dioxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Lg Household & Health Care Ltd |
| 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: | ENSULIZOLE - .405 g/15g
TITANIUM DIOXIDE - .819 g/15g
|
| 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: | 04 Feb, 2021 |
| 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: | LG HOUSEHOLD & HEALTH CARE LTD
|
| 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: | 9YQ9DI1W42
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 |
|---|
| 53208-063-03 | 2 CONTAINER in 1 BOX (53208-063-03) / 15 g in 1 CONTAINER | 04 Feb, 2021 | 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:
Purpose sunscreen
Product Elements:
Thefaceshop cushion cc total cover spf 50 natural beige ensulizole, titanium dioxide biosaccharide gum-1 silicon dioxide mica triethoxycaprylylsilane sodium palmitoyl sarcosinate palmitic acid calcium carbonate albizia julibrissin bark butylene glycol dimethicone crosspolymer (450000 mpa.s at 12% in cyclopentasiloxane) methyl methacrylate dimethicone/vinyl dimethicone crosspolymer (hard particle) zinc stearate disteardimonium hectorite sodium chloride sorbitan sesquioleate aluminum hydroxide distearyldimonium chloride distearyldimonium triethylhexanoin peg-10 dimethicone (600 cst) dipropylene glycol niacinamide tromethamine 1,2-hexanediol stearic acid sorbitan sesquiisostearate .alpha.-tocopherol acetate palmitoyl proline tangerine peel adenosine magnesium palmitoyl glutamate phenoxyethanol water titanium dioxide titanium dioxide ensulizole ensulizole
Warnings:
Warnings for external use only do not use âon damaged or broken skin when using this product keep out of eyes. rinse with water to remove. stop use and ask doctor rash or irritation develops and lasts. 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 âon damaged or broken skin when using this product keep out of eyes. rinse with water to remove. stop use and ask doctor rash or irritation develops and lasts. 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 apply liberally 15 minutes before sun exposure and as needed. reapply as needed or after towel drying, swimming, or sweating. 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. to 2 p.m. - wear long-sleeved shirts, pants, hats, and sunglasses children under 6 months: ask a doctor
Stop Use:
Stop use and ask doctor rash or irritation develops and lasts.
Package Label Principal Display Panel:
Principal display panel cc total cover cushion broad spectrum spf 50 thefaceshop net wt. 0.52 oz | 15g v203 natural beige thefaceshop cc total cover cushion high coverage | brightening [broad spectrum spf 50] imported by lg h&h usa, inc. 165 broadway, one liberty plaza, 25th floor new york, ny 10006, usa questions: 1-888-498-9004 / made in korea tfs cc total cover cushion spf 50 natural beige
Further Questions:
Questions? call 1-888-498-9004