Cc Cream Broad Spectrum Spf 30 Merle Norman

Homosalate, Octinoxate, Oxybenzone, Titanium Dioxide


Merle Norman Cosmetics
Human Otc Drug
NDC 57627-170
Cc Cream Broad Spectrum Spf 30 Merle Norman also known as Homosalate, Octinoxate, Oxybenzone, Titanium Dioxide is a human otc drug labeled by 'Merle Norman Cosmetics'. National Drug Code (NDC) number for Cc Cream Broad Spectrum Spf 30 Merle Norman is 57627-170. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Cc Cream Broad Spectrum Spf 30 Merle Norman drug includes Homosalate - 7 g/100g Octinoxate - 2.5 g/100g Oxybenzone - 2 g/100g Titanium Dioxide - 4.1 g/100g . The currest status of Cc Cream Broad Spectrum Spf 30 Merle Norman drug is Active.

Drug Information:

Drug NDC: 57627-170
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: Cc Cream Broad Spectrum Spf 30 Merle Norman
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base: Cc Cream Broad Spectrum Spf 30
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: Homosalate, Octinoxate, Oxybenzone, Titanium Dioxide
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Merle Norman Cosmetics
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:HOMOSALATE - 7 g/100g
OCTINOXATE - 2.5 g/100g
OXYBENZONE - 2 g/100g
TITANIUM DIOXIDE - 4.1 g/100g
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: 19 Jun, 2014
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 08 May, 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:Merle Norman Cosmetics
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:V06SV4M95S
4Y5P7MUD51
95OOS7VE0Y
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
57627-170-021 TUBE in 1 CARTON (57627-170-02) / 35 g in 1 TUBE (57627-170-01)19 Jun, 2014N/ANo
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 withother sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun utilisations • aide à prévenir les coups de soleil • amoindrit le risque de cancer et de vieillissement prématuré de la peau causés par le soleil lorsque utilisé comme indiqué en conjonction avec d’autres mesures de protection solaire (voir mode d’emploi). keep out of reach of children stop use and ask a doctor if rash occurs. en cas de rougeurs cessez l'utilisationet consultez un medecin. 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. if swallowed, get medical help or contact a poison control center right away. avertissements À usage externe seulement ne pas utilisersur une peau abîmée ou des plaies ouvertes faites attention à vos yeux lorsque vous utilisez ce produit. nettoyez avec de l’eau. ne pas laisser à la portée des enfants. si vous avalez ce produit, consultez un médecin ou contactez immédiatement un centre antipoison. drug facts 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, 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: ask a doctor mode d’emploi • pour vous protéger de soleil: • appliquez généreusement et uniformément 15 minutes avant de vous mettre au soleil • utilisez un écran solaire résistant a l’eau si vous nagez ou transpirez • réappliquez au moins toutes les 2 heures • mesures de protection contre le soleil. l’exposition au soleil accroît le risque de cancer et de vieillissement prématuré de la peau. pour amoindrir ce risque, utilisez régulièrement un écran solaire à ample protection fps 15 ou plus et observez d’autres mesures de protection contre le soleil telles que: • limiter le temps d’exposition au soleil, surtout entre 10 heures et 14 heures • porter des chemises à manches longues, des pantalons, des chapeaux et des lunettes de soleil • pour les enfants de moins de 6 mois: consulter un médecin inactive (non-medicinal)ingredients water (aqua), methy l trimethicone, propylene glycol dicaprylate/dicaprate, isododecane, c12-15 alkyl benzoate, cetyl peg/ppg-10/1 dimethicone, glycerin, hdi/trimethylol hexyllactone crosspolymer, silica, vinyl dimethicone/methicone silsesquioxane crosspolymer, dimethicone, magnesium sulfate, lauroyl lysine, tocopheryl acetate, citrulluslanatus (watermelon) fruit extract, lens esculenta (lentil) fruit extract, pyrus malus(apple) fruit extract, hippophae rhamnoides fruit extract,portulaca oleracea extract,palmitoyl tripeptide-38, sodium pca, sodium lactate,sodium ascorbyl glucoside, sodium myristoyl glutamate,maltodextrin, sorbitan sesquioleate, aluminum hydroxide (ci 77002), stearic acid, cyclopentasiloxane, caprylyl glycol, zinc oxide (ci 77947), butylene glycol, ethylhexylglycerin, acrylates/ dimethicone copolymer, dimethicone/peg-10/15 crosspolymer, triethoxycaprylylsilane, sorbic acid, trisodium edta, hydroxypropyl cyclodextrin, potassium sorbate, sodium benzoate, disteardimonium hectorite, propylene carbonate, phenoxyethanol, methylparaben, propylparaben, ethylparaben, may contain/ peut contenir (+/-), iron oxides (ci 77489, ci 77491, ci 77492, ci 77499), titanium dioxide (ci 77891).

Product Elements:

Cc cream broad spectrum spf 30 merle norman homosalate, octinoxate, oxybenzone, titanium dioxide homosalate homosalate octinoxate octinoxate oxybenzone oxybenzone titanium dioxide titanium dioxide water methyl trimethicone propylene glycol dicaprylate/dicaprate isododecane alkyl (c12-15) benzoate cetyl peg/ppg-10/1 dimethicone (hlb 2) glycerin silicon dioxide dimethicone magnesium sulfate, unspecified form lauroyl lysine .alpha.-tocopherol acetate watermelon lens culinaris fruit apple hippophae rhamnoides fruit purslane sodium pyrrolidone carboxylate sodium lactate sodium myristoyl glutamate maltodextrin sorbitan sesquioleate aluminum hydride stearic acid cyclomethicone 5 caprylyl glycol zinc oxide butylene glycol ethylhexylglycerin triethoxycaprylylsilane sorbic acid edetate trisodium potassium sorbate sodium benzoate disteardimonium hectorite propylene carbonate phenoxyethanol methylparaben ethylparaben ferrous oxide ferric oxide red ferrosoferric oxide

Indications and Usage:

Stop use and ask a doctor if rash occurs. en cas de rougeurs cessez l'utilisationet consultez un medecin. 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. if swallowed, get medical help or contact a poison control center right away. avertissements À usage externe seulement ne pas utilisersur une peau abîmée ou des plaies ouvertes faites attention à vos yeux lorsque vous utilisez ce produit. nettoyez avec de l’eau. ne pas laisser à la portée des enfants. si vous avalez ce produit, consultez un médecin ou contactez immédiatement un centre antipoison. drug facts 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, 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: ask a doctor mode d’emploi • pour vous protéger de soleil: • appliquez généreusement et uniformément 15 minutes avant de vous mettre au soleil • utilisez un écran solaire résistant a l’eau si vous nagez ou transpirez • réappliquez au moins toutes les 2 heures • mesures de protection contre le soleil. l’exposition au soleil accroît le risque de cancer et de vieillissement prématuré de la peau. pour amoindrir ce risque, utilisez régulièrement un écran solaire à ample protection fps 15 ou plus et observez d’autres mesures de protection contre le soleil telles que: • limiter le temps d’exposition au soleil, surtout entre 10 heures et 14 heures • porter des chemises à manches longues, des pantalons, des chapeaux et des lunettes de soleil • pour les enfants de moins de 6 mois: consulter un médecin inactive (non-medicinal)ingredients water (aqua), methy l trimethicone, propylene glycol dicaprylate/dicaprate, isododecane, c12-15 alkyl benzoate, cetyl peg/ppg-10/1 dimethicone, glycerin, hdi/trimethylol hexyllactone crosspolymer, silica, vinyl dimethicone/methicone silsesquioxane crosspolymer, dimethicone, magnesium sulfate, lauroyl lysine, tocopheryl acetate, citrulluslanatus (watermelon) fruit extract, lens esculenta (lentil) fruit extract, pyrus malus(apple) fruit extract, hippophae rhamnoides fruit extract,portulaca oleracea extract,palmitoyl tripeptide-38, sodium pca, sodium lactate,sodium ascorbyl glucoside, sodium myristoyl glutamate,maltodextrin, sorbitan sesquioleate, aluminum hydroxide (ci 77002), stearic acid, cyclopentasiloxane, caprylyl glycol, zinc oxide (ci 77947), butylene glycol, ethylhexylglycerin, acrylates/ dimethicone copolymer, dimethicone/peg-10/15 crosspolymer, triethoxycaprylylsilane, sorbic acid, trisodium edta, hydroxypropyl cyclodextrin, potassium sorbate, sodium benzoate, disteardimonium hectorite, propylene carbonate, phenoxyethanol, methylparaben, propylparaben, ethylparaben, may contain/ peut contenir (+/-), iron oxides (ci 77489, ci 77491, ci 77492, ci 77499), titanium dioxide (ci 77891).

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. if swallowed, get medical help or contact a poison control center right away. avertissements À usage externe seulement ne pas utilisersur une peau abîmée ou des plaies ouvertes faites attention à vos yeux lorsque vous utilisez ce produit. nettoyez avec de l’eau. ne pas laisser à la portée des enfants. si vous avalez ce produit, consultez un médecin ou contactez immédiatement un centre antipoison. drug facts 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, 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: ask a doctor mode d’emploi • pour vous protéger de soleil: • appliquez généreusement et uniformément 15 minutes avant de vous mettre au soleil • utilisez un écran solaire résistant a l’eau si vous nagez ou transpirez • réappliquez au moins toutes les 2 heures • mesures de protection contre le soleil. l’exposition au soleil accroît le risque de cancer et de vieillissement prématuré de la peau. pour amoindrir ce risque, utilisez régulièrement un écran solaire à ample protection fps 15 ou plus et observez d’autres mesures de protection contre le soleil telles que: • limiter le temps d’exposition au soleil, surtout entre 10 heures et 14 heures • porter des chemises à manches longues, des pantalons, des chapeaux et des lunettes de soleil • pour les enfants de moins de 6 mois: consulter un médecin inactive (non-medicinal)ingredients water (aqua), methy l trimethicone, propylene glycol dicaprylate/dicaprate, isododecane, c12-15 alkyl benzoate, cetyl peg/ppg-10/1 dimethicone, glycerin, hdi/trimethylol hexyllactone crosspolymer, silica, vinyl dimethicone/methicone silsesquioxane crosspolymer, dimethicone, magnesium sulfate, lauroyl lysine, tocopheryl acetate, citrulluslanatus (watermelon) fruit extract, lens esculenta (lentil) fruit extract, pyrus malus(apple) fruit extract, hippophae rhamnoides fruit extract,portulaca oleracea extract,palmitoyl tripeptide-38, sodium pca, sodium lactate,sodium ascorbyl glucoside, sodium myristoyl glutamate,maltodextrin, sorbitan sesquioleate, aluminum hydroxide (ci 77002), stearic acid, cyclopentasiloxane, caprylyl glycol, zinc oxide (ci 77947), butylene glycol, ethylhexylglycerin, acrylates/ dimethicone copolymer, dimethicone/peg-10/15 crosspolymer, triethoxycaprylylsilane, sorbic acid, trisodium edta, hydroxypropyl cyclodextrin, potassium sorbate, sodium benzoate, disteardimonium hectorite, propylene carbonate, phenoxyethanol, methylparaben, propylparaben, ethylparaben, may contain/ peut contenir (+/-), iron oxides (ci 77489, ci 77491, ci 77492, ci 77499), titanium dioxide (ci 77891).

Dosage and Administration:

Drug facts 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, 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: ask a doctor mode d’emploi • pour vous protéger de soleil: • appliquez généreusement et uniformément 15 minutes avant de vous mettre au soleil • utilisez un écran solaire résistant a l’eau si vous nagez ou transpirez • réappliquez au moins toutes les 2 heures • mesures de protection contre le soleil. l’exposition a
u soleil accroît le risque de cancer et de vieillissement prématuré de la peau. pour amoindrir ce risque, utilisez régulièrement un écran solaire à ample protection fps 15 ou plus et observez d’autres mesures de protection contre le soleil telles que: • limiter le temps d’exposition au soleil, surtout entre 10 heures et 14 heures • porter des chemises à manches longues, des pantalons, des chapeaux et des lunettes de soleil • pour les enfants de moins de 6 mois: consulter un médecin inactive (non-medicinal)ingredients water (aqua), methy l trimethicone, propylene glycol dicaprylate/dicaprate, isododecane, c12-15 alkyl benzoate, cetyl peg/ppg-10/1 dimethicone, glycerin, hdi/trimethylol hexyllactone crosspolymer, silica, vinyl dimethicone/methicone silsesquioxane crosspolymer, dimethicone, magnesium sulfate, lauroyl lysine, tocopheryl acetate, citrulluslanatus (watermelon) fruit extract, lens esculenta (lentil) fruit extract, pyrus malus(apple) fruit extract, hippophae rhamnoides fruit extract,portulaca oleracea extract,palmitoyl tripeptide-38, sodium pca, sodium lactate,sodium ascorbyl glucoside, sodium myristoyl glutamate,maltodextrin, sorbitan sesquioleate, aluminum hydroxide (ci 77002), stearic acid, cyclopentasiloxane, caprylyl glycol, zinc oxide (ci 77947), butylene glycol, ethylhexylglycerin, acrylates/ dimethicone copolymer, dimethicone/peg-10/15 crosspolymer, triethoxycaprylylsilane, sorbic acid, trisodium edta, hydroxypropyl cyclodextrin, potassium sorbate, sodium benzoate, disteardimonium hectorite, propylene carbonate, phenoxyethanol, methylparaben, propylparaben, ethylparaben, may contain/ peut contenir (+/-), iron oxides (ci 77489, ci 77491, ci 77492, ci 77499), titanium dioxide (ci 77891).

Package Label Principal Display Panel:

Cc cream broad spectrum spf 30 complexion corrector creme correctrice de teint large spectre fps 30 merle norman 35 g net wt. 1.25 oz carton tube


Comments/ Reviews:

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