Creamy Beige Perfecting Makeup Broad Spectrum Spf 25 Merle Norman
Octinoxate, Titanium Dioxide
Merle Norman Cosmetics, Inc
Human Otc Drug
NDC 57627-128Creamy Beige Perfecting Makeup Broad Spectrum Spf 25 Merle Norman also known as Octinoxate, Titanium Dioxide is a human otc drug labeled by 'Merle Norman Cosmetics, Inc'. National Drug Code (NDC) number for Creamy Beige Perfecting Makeup Broad Spectrum Spf 25 Merle Norman is 57627-128. This drug is available in dosage form of Emulsion. The names of the active, medicinal ingredients in Creamy Beige Perfecting Makeup Broad Spectrum Spf 25 Merle Norman drug includes Octinoxate - 2.25 g/30mL Titanium Dioxide - 2.13 g/30mL . The currest status of Creamy Beige Perfecting Makeup Broad Spectrum Spf 25 Merle Norman drug is Active.
Drug Information:
| Drug NDC: | 57627-128 |
| 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: | Creamy Beige Perfecting Makeup Broad Spectrum Spf 25 Merle Norman |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Creamy Beige Perfecting Makeup Broad Spectrum Spf 25 |
| 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, Titanium Dioxide |
| 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: | 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 - 2.25 g/30mL
TITANIUM DIOXIDE - 2.13 g/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: | 22 Aug, 2012 |
| 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
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 |
|---|
| 57627-128-02 | 1 BOTTLE in 1 CARTON (57627-128-02) / 30 mL in 1 BOTTLE (57627-128-01) | 22 Aug, 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:
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 · keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. · stop use and ask a doctor if rash occurs and persists 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. directions · 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 broad spectrum spf 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-sleeve shirts, pants, hats, and sunglasses · children under 6 months: ask a doctor inactive ingredients water (aqua), cyclopenta siloxane, clyclohexasiloxane, isododecane, alcohol denat., cetyl peg/ppg-10/1 dimethicone, c12-15 alkyl benzoate, acrylates/dimethicone copolymer, silica, acrylates copolymer, sodium myristoyl glutamate, sorbitan sesquioleate, polyhydroxystearic acid, disteardimonium hectorite, caprylyl glycol, aluminum oxide, stearic acid, propylene glycol, propylene carbonate, tetrasodium edta, methylisothiazolinone, may contain: iron oxides, titanium dioxide, triethoxycaprylylsilane
Product Elements:
Creamy beige perfecting makeup broad spectrum spf 25 merle norman octinoxate, titanium dioxide octinoxate octinoxate titanium dioxide titanium dioxide water cyclomethicone 5 cyclomethicone 6 isododecane cetyl peg/ppg-10/1 dimethicone (hlb 2) alkyl (c12-15) benzoate silicon dioxide disodium myristoyl glutamate sorbitan sesquioleate polyhydroxystearic acid (2300 mw) caprylyl glycol aluminum oxide stearic acid propylene glycol propylene carbonate edetate disodium methylisothiazolinone ferric oxide red ferric oxide yellow ferrosoferric oxide triethoxycaprylylsilane
Indications and Usage:
· stop use and ask a doctor if rash occurs and persists 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. directions · 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 broad spectrum spf 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-sleeve shirts, pants, hats, and sunglasses · children under 6 months: ask a doctor inactive ingredients water (aqua), cyclopenta siloxane, clyclohexasiloxane, isododecane, alcohol denat., cetyl peg/ppg-10/1 dimethicone, c12-15 alkyl benzoate, acrylates/dimethicone copolymer, silica, acrylates copolymer
Read more..., sodium myristoyl glutamate, sorbitan sesquioleate, polyhydroxystearic acid, disteardimonium hectorite, caprylyl glycol, aluminum oxide, stearic acid, propylene glycol, propylene carbonate, tetrasodium edta, methylisothiazolinone, may contain: iron oxides, titanium dioxide, triethoxycaprylylsilane
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. directions · 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 broad spectrum spf 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-sleeve shirts, pants, hats, and sunglasses · children under 6 months: ask a doctor inactive ingredients water (aqua), cyclopenta siloxane, clyclohexasiloxane, isododecane, alcohol denat., cetyl peg/ppg-10/1 dimethicone, c12-15 alkyl benzoate, acrylates/dimethicone copolymer, silica, acrylates copolymer, sodium myristoyl glutamate, sorbitan sesquioleate, polyhy
Read more...droxystearic acid, disteardimonium hectorite, caprylyl glycol, aluminum oxide, stearic acid, propylene glycol, propylene carbonate, tetrasodium edta, methylisothiazolinone, may contain: iron oxides, titanium dioxide, triethoxycaprylylsilane
Dosage and Administration:
Directions · 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 broad spectrum spf 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-sleeve shirts, pants, hats, and sunglasses · children under 6 months: ask a doctor inactive ingredients water (aqua), cyclopenta siloxane, clyclohexasiloxane, isododecane, alcohol denat., cetyl peg/ppg-10/1 dimethicone, c12-15 alkyl benzoate, acrylates/dimethicone copolymer, silica, acrylates copolymer, sodium myristoyl glutamate, sorbitan sesquioleate, polyhydroxystearic acid, disteardimonium hectorite, caprylyl glycol, aluminum oxide, stearic acid, propylene glycol, propylene carbonate, tetrasodium edta, met
Read more...hylisothiazolinone, may contain: iron oxides, titanium dioxide, triethoxycaprylylsilane
Package Label Principal Display Panel:
Perfecting makeup broad spectrum spf 25 merle norman established in los angeles since 1931 30 ml 1 fl. oz. image of carton art image of bottle art