Timeless Illuminating Makeup Spf 30 Simply Beige Merle Norman
Octinoxate, Oxybenzone
Merle Norman Cosmetics, Inc
Human Otc Drug
NDC 57627-179Timeless Illuminating Makeup Spf 30 Simply Beige Merle Norman also known as Octinoxate, Oxybenzone is a human otc drug labeled by 'Merle Norman Cosmetics, Inc'. National Drug Code (NDC) number for Timeless Illuminating Makeup Spf 30 Simply Beige Merle Norman is 57627-179. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Timeless Illuminating Makeup Spf 30 Simply Beige Merle Norman drug includes Octinoxate - 7.5 g/100mL Oxybenzone - 2 g/100mL . The currest status of Timeless Illuminating Makeup Spf 30 Simply Beige Merle Norman drug is Active.
Drug Information:
| Drug NDC: | 57627-179 |
| 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: | Timeless Illuminating Makeup Spf 30 Simply Beige Merle Norman |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Timeless Illuminating Makeup Spf 30 Simply Beige |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Merle Norman |
| 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, Oxybenzone |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Merle Norman Cosmetics, Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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 - 7.5 g/100mL
OXYBENZONE - 2 g/100mL
|
| 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 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: | 24 Jan, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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: | Merle Norman Cosmetics, 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
95OOS7VE0Y
|
| 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 |
|---|
| 57627-179-02 | 1 BOTTLE in 1 CARTON (57627-179-02) / 30 mL in 1 BOTTLE (57627-179-01) | 24 Jan, 2017 | 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:
âuses helps prevent sunburn if used as directed with other sun protection measures (see âdirections â), decreases the risk of skin cancer and early skin aging caused by the sun
Product Elements:
Timeless illuminating makeup spf 30 simply beige merle norman octinoxate, oxybenzone octinoxate octinoxate oxybenzone oxybenzone water cyclomethicone 5 titanium dioxide medium-chain triglycerides phenyl trimethicone methyl trimethicone aluminum oxide trimethylsiloxysilicate (m/q 0.6-0.8) dimethicone butylene glycol glycerin gold hydroxyethyl cellulose (100 mpa.s at 2%) hexamethylene diisocyanate/trimethylol hexyllactone crosspolymer polymethylsilsesquioxane (4.5 microns) triethoxycaprylylsilane peg-9 polydimethylsiloxyethyl dimethicone dextrin palmitate (corn; 20000 mw) caprylyl trisiloxane cetyl peg/ppg-10/1 dimethicone (hlb 2) silicon dioxide mica diethylene glycol monoethyl ether magnesium sulfate, unspecified form caprylyl glycol ethylhexylglycerin hexylene glycol phenoxyethanol edetate sodium potassium sorbate talc barium sulfate bismuth oxychloride ferrous oxide ferric oxide red ferric oxide yellow ferrosoferric oxide ultramarine blue
Indications and Usage:
âstop use and ask a doctor âif rash occurs
Warnings:
âwarnings for external use only do not use on domaged or broken skin âwhen using this product âkeep out of eyes. rinse with water to remove.
Dosage and Administration:
Directions for sunscreen use: apply liberally and evenly 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, regulary use a sunscreeen with a broad spectrum spf value of 15 or higher and other sun protection measures including: limit tim in the sun, especially from 10a.m. - 2p.m. wear long-sleeved shirts, pants, hats, and sunglasses children under 6 months: ask a doctor
Package Label Principal Display Panel:
Timeless illuminating makeup broad spectrum spf 30 merle norman 30 ml e 1 fl. oz. image description image description