Loreal Paris Infallible Up To 24 H Fresh Wear Foundation Broad Spectrum Spf 25 Sunscreen
Octinoxate And Titanium Dioxide
L'oreal Usa Products Inc
Human Otc Drug
NDC 49967-009Loreal Paris Infallible Up To 24 H Fresh Wear Foundation Broad Spectrum Spf 25 Sunscreen also known as Octinoxate And Titanium Dioxide is a human otc drug labeled by 'L'oreal Usa Products Inc'. National Drug Code (NDC) number for Loreal Paris Infallible Up To 24 H Fresh Wear Foundation Broad Spectrum Spf 25 Sunscreen is 49967-009. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Loreal Paris Infallible Up To 24 H Fresh Wear Foundation Broad Spectrum Spf 25 Sunscreen drug includes Octinoxate - 67 mg/mL Titanium Dioxide - 36 mg/mL . The currest status of Loreal Paris Infallible Up To 24 H Fresh Wear Foundation Broad Spectrum Spf 25 Sunscreen drug is Active.
Drug Information:
| Drug NDC: | 49967-009 |
| 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: | Loreal Paris Infallible Up To 24 H Fresh Wear Foundation Broad Spectrum Spf 25 Sunscreen |
| 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: | L'oreal Usa Products Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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 - 67 mg/mL
TITANIUM DIOXIDE - 36 mg/mL
|
| 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, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 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: | L'Oreal USA Products 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. |
| UPC: | 0000000000000
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 49967-009-01 | 30 mL in 1 BOTTLE (49967-009-01) | 01 Oct, 2018 | 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:
Loreal paris infallible up to 24 h fresh wear foundation broad spectrum spf 25 sunscreen octinoxate and titanium dioxide octinoxate octinoxate titanium dioxide titanium dioxide water dimethicone isododecane alcohol trimethylsiloxysilicate (m/q 0.6-0.8) butylene glycol peg-10 dimethicone (600 cst) perlite magnesium potassium aluminosilicate fluoride nylon-12 isopropyl lauroyl sarcosinate diisopropyl sebacate disteardimonium hectorite hexamethylene diisocyanate/trimethylol hexyllactone crosspolymer bis-peg/ppg-14/14 dimethicone magnesium sulfate, unspecified form aluminum hydroxide phenoxyethanol disodium stearoyl glutamate hydrogen dimethicone (13 cst) dipentaerythrityl tetrahydroxystearate/tetraisostearate tocopherol .alpha.-hexylcinnamaldehyde silicon dioxide isobutane benzyl salicylate linalool, (+/-)- isomethyl-.alpha.-ionone benzyl alcohol butylated hydroxytoluene .beta.-citronellol, (r)- ferric oxide red ferric ammonium ferrocyanide
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:
Warnings for external use only
When Using:
When using this product keep out of eyes. rinse with water to remove.
Dosage and Administration:
Directions for sunscreen use: ? shake well ? apply liberally 15 minutes before sun exposure ? reapply at least every 2 hours ? use a water resistant sunscreen if 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. 2 p.m. ? wear long-sleeved shirts, pants, hats, and sunglasses ? children under 6 months of age: ask a doctor
Stop Use:
Stop use and ask a doctor if rash occurs
Package Label Principal Display Panel:
Image of front label
Image of back label
Further Questions:
Questions or comments? 1-800-322-2036 monday - friday (10 a.m. - 5 p.m. est)