Spf 50 Uva/uvb
Ensulizole, Oxybenzone, Avobenzone, Octocrylene
Multaler Et Cie S.a.s.
Human Otc Drug
NDC 51191-3015Spf 50 Uva/uvb also known as Ensulizole, Oxybenzone, Avobenzone, Octocrylene is a human otc drug labeled by 'Multaler Et Cie S.a.s.'. National Drug Code (NDC) number for Spf 50 Uva/uvb is 51191-3015. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Spf 50 Uva/uvb drug includes Avobenzone - 3 g/100g Ensulizole - 3 g/100g Octocrylene - 8 g/100g Oxybenzone - 5 g/100g . The currest status of Spf 50 Uva/uvb drug is Active.
Drug Information:
| Drug NDC: | 51191-3015 |
| 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: | Spf 50 Uva/uvb |
| 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, Oxybenzone, Avobenzone, Octocrylene |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Multaler Et Cie S.a.s. |
| 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: | AVOBENZONE - 3 g/100g
ENSULIZOLE - 3 g/100g
OCTOCRYLENE - 8 g/100g
OXYBENZONE - 5 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 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: | 15 Apr, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 Jun, 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: | MULTALER ET CIE S.A.S.
|
| 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: | 0832630003935
|
| UPC stands for Universal Product Code. |
| UNII: | G63QQF2NOX
9YQ9DI1W42
5A68WGF6WM
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 |
|---|
| 51191-3015-1 | 50 g in 1 TUBE (51191-3015-1) | 15 Apr, 2013 | 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. |
Product Elements:
Spf 50 uva/uvb ensulizole, oxybenzone, avobenzone, octocrylene water alkyl (c12-15) benzoate glycerin ppg-12/smdi copolymer glyceryl monostearate peg-100 stearate .alpha.-bisabolol, (+/-)- chlorphenesin xanthan gum sodium acrylate/sodium acryloyldimethyltaurate copolymer (4000000 mw) edetate sodium magnesium aluminum silicate propylene glycol apricot kernel oil sorbitan monostearate .alpha.-tocopherol acetate panthenol isohexadecane vitamin a palmitate green tea leaf glycyrrhizinate dipotassium maltodextrin polysorbate 80 aspalathus linearis leaf caprylhydroxamic acid caprylyl glycol sunflower oil dimethicone tromethamine octocrylene octocrylene oxybenzone oxybenzone avobenzone avobenzone ensulizole ensulizole pantolactone, (+/-)- tocopherol
Warnings and Cautions:
Drug facts active ingredients purpose ensulizole 3% { oxybenzone 5% { sunscreen avobenzone 3% { octocrylene 8% { solar care spf 50 uva/uvb broad spectrum creme solaire haute protection aux 3 thés sunscreen cream high protection with 3 teas crème solaire aux 3 thés. haute protection spf 50. sunscreen cream with 3 teas. high protection spf 50 crema solar con 3 tés. alta proteccion spf 50. sonnencreme mit dreierlei tee. hoher schutz spf 50. crema solare con 3 tè. alta protezione spf 50. zonnencrème met 3 theesorten. hoge bescherming spf 50. creme solar à base de 3 chas. alta protecçao spf 50. aide à prévenir les coups de soleil. appliquer généreusement avant toute exposition. renouveler fréquemment et généreusement l'application pour maintenir la protection, surtout après avoir transpiré, avoir nagé ou s'être essuyé. pour les enfants de moins de 6 mois, consulter un médecin. avertissement : pour usage externe seulement. eviter
Read more... tout contact avec les yeux. en cas de contact, rincer abon- damment. cesser d'utiliser et consulter un médecin en cas d'irritations ou d'éruptions cutanées. tenir hors de la portée des enfants. en cas d'absorption, consulter un médecin ou le centre anti-poisons. recommandations : eviter de trop vous exposer aux heures les plus chaudes de la journée. ne restez pas trop long- temps au soleil. même si vous utilisez un produit de protection solaire. pro- tégez-vous avec un chapeau, un t-shirt et des lunettes de soleil. n'exposez pas les bébés et les jeunes enfants directe- ment au soleil. la surexposition au soleil est une menace sérieuse pour la santé. contient benzophenone-3 contains benzophenone-3 non comedogene non comedogenic tolerance testee sous controle dermatologique tolerance tested by dermatologists uses ⢠hels prevent sunburn. warnings for external use only. do not use on damaged or broken skin. stop use and ask a doctor if rash occurs. when using this product keep out of eyes. rinse with water to remove. keep out of reach of children . if swallowed, get medical help or contact poison control center right away. directions ⢠apply liberally 15 minutes before sun exposure. ⢠use a water resistant sunscreen if swimming or sweating. reapply at least every 2 hours. children under 6 months : ask a doctor. ⢠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 sprectrum spf value of 15 or higher and other sun protection measures including: ⢠limit time in the sun, especially from 10 a.m-2p.m ⢠wear long-sleeved shirts, pants, and sunglasses. other information ⢠protect this product from excessive heat and direct sun. inactive ingredients aqua/water/eau, c12-15 alkyl benzoate , glyceryl stearate, ppg-12/smdi copolymer, glycerin , peg-100 stearate, tromethamine, magnesium aluminum silicate, propylene glycol, prunus armeniaca (apricot) kernel oil, sorbitan stearate, caprylyl glycol, bisabolol , dimethicone, chlorphenesin, xanthan gum, sodium acrylate/sodium acryloyldimethyl taurate copolymer, tocopheryl acetate , panthenol, caprylhydroxamic acid, camellia sinensis leaf extract, isohexadecane, tetrasodium edta, retinyl palmitate, dipotassium glycyrrhizate, maltodextrin, polysorbate 80, aspalathus linearis leaf extract , helianthus annuus (sunflower) seed oil, pantolactone, tocopherol.
Uses ⢠hels prevent sunburn. warnings for external use only. do not use on damaged or broken skin. stop use and ask a doctor if rash occurs. when using this product keep out of eyes. rinse with water to remove. keep out of reach of children . if swallowed, get medical help or contact poison control center right away. directions ⢠apply liberally 15 minutes before sun exposure. ⢠use a water resistant sunscreen if swimming or sweating. reapply at least every 2 hours. children under 6 months : ask a doctor. ⢠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 sprectrum spf value of 15 or higher and other sun protection measures including: ⢠limit time in the sun, especially from 10 a.m-2p.m ⢠wear long-sleeved shirts, pants, and sunglasses. other information ⢠protect this product from excessive heat and direct sun. inactive ingredients
Read more... aqua/water/eau, c12-15 alkyl benzoate , glyceryl stearate, ppg-12/smdi copolymer, glycerin , peg-100 stearate, tromethamine, magnesium aluminum silicate, propylene glycol, prunus armeniaca (apricot) kernel oil, sorbitan stearate, caprylyl glycol, bisabolol , dimethicone, chlorphenesin, xanthan gum, sodium acrylate/sodium acryloyldimethyl taurate copolymer, tocopheryl acetate , panthenol, caprylhydroxamic acid, camellia sinensis leaf extract, isohexadecane, tetrasodium edta, retinyl palmitate, dipotassium glycyrrhizate, maltodextrin, polysorbate 80, aspalathus linearis leaf extract , helianthus annuus (sunflower) seed oil, pantolactone, tocopherol.
Description:
Solar care spf 50 uva/uvb broad spectrum creme solaire haute protection aux 3 thés sunscreen cream high protection with 3 teas crème solaire aux 3 thés. haute protection spf 50. sunscreen cream with 3 teas. high protection spf 50 crema solar con 3 tés. alta proteccion spf 50. sonnencreme mit dreierlei tee. hoher schutz spf 50. crema solare con 3 tè. alta protezione spf 50. zonnencrème met 3 theesorten. hoge bescherming spf 50. creme solar à base de 3 chas. alta protecçao spf 50. aide à prévenir les coups de soleil. appliquer généreusement avant toute exposition. renouveler fréquemment et généreusement l'application pour maintenir la protection, surtout après avoir transpiré, avoir nagé ou s'être essuyé. pour les enfants de moins de 6 mois, consulter un médecin. avertissement : pour usage externe seulement. eviter tout contact avec les yeux. en cas de contact, rincer abon- damment. cesser d'utiliser et consulter un médecin en cas d'irritations ou d'éruptions cutanées. tenir hors de la portée des enfants. en cas d'absorption, consulter un médecin ou le centre anti-poisons. recommandations : eviter de trop vous exposer aux heures les plus chaudes de la journée. ne restez pas trop long- temps au soleil. même si vous utilisez un produit de protection solaire. pro- tégez-vous avec un chapeau, un t-shirt et des lunettes de soleil. n'exposez pas les bébés et les jeunes enfants directe- ment au soleil. la surexposition au soleil est une menace sérieuse pour la santé. contient benzophenone-3 contains benzophenone-3 non comedogene non comedogenic tolerance testee sous controle dermatologique tolerance tested by dermatologists uses ⢠hels prevent sunburn. warnings for external use only. do not use on damaged or broken skin. stop use and ask a doctor if rash occurs. when using this product keep out of eyes. rinse with water to remove. keep out of reach of children . if swallowed, get medical help or contact poison control center right away. directions ⢠apply liberally 15 minutes before sun exposure. ⢠use a water resistant sunscreen if swimming or sweating. reapply at least every 2 hours. children under 6 months : ask a doctor. ⢠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 sprectrum spf value of 15 or higher and other sun protection measures including: ⢠limit time in the sun, especially from 10 a.m-2p.m ⢠wear long-sleeved shirts, pants, and sunglasses. other information ⢠protect this product from excessive heat and direct sun. inactive ingredients aqua/water/eau, c12-15 alkyl benzoate , glyceryl stearate, ppg-12/smdi copolymer, glycerin , peg-100 stearate, tromethamine, magnesium aluminum silicate, propylene glycol, prunus armeniaca (apricot) kernel oil, sorbitan stearate, caprylyl glycol, bisabolol , dimethicone, chlorphenesin, xanthan gum, sodium acrylate/sodium acryloyldimethyl taurate copolymer, tocopheryl acetate , panthenol, caprylhydroxamic acid, camellia sinensis leaf extract, isohexadecane, tetrasodium edta, retinyl palmitate, dipotassium glycyrrhizate, maltodextrin, polysorbate 80, aspalathus linearis leaf extract , helianthus annuus (sunflower) seed oil, pantolactone, tocopherol.
Package Label Principal Display Panel:
Box spf 50