Radiance Superbe Day Cream Neutral Light
Ensulizole, Octocrylene, Titanium Dioxide, Zinc Oxide
Haute Custom Beauty
Human Otc Drug
NDC 72414-002Radiance Superbe Day Cream Neutral Light also known as Ensulizole, Octocrylene, Titanium Dioxide, Zinc Oxide is a human otc drug labeled by 'Haute Custom Beauty'. National Drug Code (NDC) number for Radiance Superbe Day Cream Neutral Light is 72414-002. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Radiance Superbe Day Cream Neutral Light drug includes Ensulizole - 4 g/100g Octocrylene - 6 g/100g Titanium Dioxide - 5 g/100g Zinc Oxide - 5 g/100g . The currest status of Radiance Superbe Day Cream Neutral Light drug is Active.
Drug Information:
| Drug NDC: | 72414-002 |
| 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: | Radiance Superbe Day Cream Neutral Light |
| 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, Octocrylene, Titanium Dioxide, Zinc Oxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Haute Custom Beauty |
| 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: | ENSULIZOLE - 4 g/100g
OCTOCRYLENE - 6 g/100g
TITANIUM DIOXIDE - 5 g/100g
ZINC OXIDE - 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: | 28 Dec, 2021 |
| 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: | Haute Custom Beauty
|
| 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: | 8436596301078
|
| UPC stands for Universal Product Code. |
| UNII: | SOI2LOH54Z
5A68WGF6WM
9YQ9DI1W42
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 |
|---|
| 72414-002-15 | 15 g in 1 APPLICATOR (72414-002-15) | 01 Jul, 2022 | N/A | No |
| 72414-002-50 | 50 g in 1 BOTTLE, PUMP (72414-002-50) | 01 Jul, 2022 | 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:
Radiance superbe day cream nude ensulizole, octocrylene, titanium dioxide, zinc oxide ceramide ap phytosphingosine glyceryl linolenate pea protein phenoxyethanol glycerin ceramide np cinnamyl alcohol benzyl salicylate olea europaea fruit volatile oil malus domestica whole royal jelly panthenol caprylic/capric/lauric triglyceride diisopropyl adipate linalool, (+)- propanediol .alpha.-tocopherol acetate polyhydroxystearic acid (2300 mw) aluminum hydroxide ammonium acryloyldimethyltaurate/vp copolymer caprylyl glycol carnauba wax cholesterol centella asiatica leaf silk, enzyme hydrolyzed (1000 mw) lecithin, soybean xanthan gum stearic acid glyceryl linoleate sodium 2-acrylamido-2-methyl-1-propane sulfonate/sodium acrylate/n-isopropylacrylamide/trimethyl(3-methacrylamidopropyl)ammonium chloride copolymer dimethylmethoxy chromanol glyceryl caprylate egg phospholipids limonene, (+/-)- .beta.-citronellol, (+/-)- sodium hydroxide squalane shea butter ceramide eos sodium lauroyl lactylate carbomer 980 eugenol hexyl cinnamate ensulizole ensulizole titanium dioxide titanium dioxide octocrylene octocrylene zinc oxide zinc oxide radiance superbe day cream neutral bronze ensulizole, octocrylene, titanium dioxide, zinc oxide ceramide ap phytosphingosine glyceryl linolenate pea protein phenoxyethanol glycerin ceramide np cinnamyl alcohol benzyl salicylate olea europaea fruit volatile oil malus domestica whole royal jelly panthenol caprylic/capric/lauric triglyceride diisopropyl adipate linalool, (+)- propanediol .alpha.-tocopherol acetate polyhydroxystearic acid (2300 mw) aluminum hydroxide ammonium acryloyldimethyltaurate/vp copolymer caprylyl glycol carnauba wax cholesterol centella asiatica leaf silk, enzyme hydrolyzed (1000 mw) lecithin, soybean xanthan gum stearic acid glyceryl linoleate sodium 2-acrylamido-2-methyl-1-propane sulfonate/sodium acrylate/n-isopropylacrylamide/trimethyl(3-methacrylamidopropyl)ammonium chloride copolymer dimethylmethoxy chromanol glyceryl caprylate egg phospholipids limonene, (+/-)- .beta.-citronellol, (+/-)- sodium hydroxide squalane shea butter ceramide eos sodium lauroyl lactylate carbomer 980 eugenol hexyl cinnamate ensulizole ensulizole titanium dioxide titanium dioxide octocrylene octocrylene zinc oxide zinc oxide radiance superbe day cream neutral light ensulizole, octocrylene, titanium dioxide, zinc oxide polyhydroxystearic acid (2300 mw) aluminum hydroxide ammonium acryloyldimethyltaurate/vp copolymer caprylyl glycol carnauba wax cholesterol ceramide ap phytosphingosine glyceryl linolenate pea protein phenoxyethanol glycerin ceramide np cinnamyl alcohol benzyl salicylate olea europaea fruit volatile oil malus domestica whole royal jelly panthenol caprylic/capric/lauric triglyceride diisopropyl adipate linalool, (+)- propanediol .alpha.-tocopherol acetate centella asiatica leaf silk, enzyme hydrolyzed (1000 mw) lecithin, soybean xanthan gum stearic acid glyceryl linoleate sodium 2-acrylamido-2-methyl-1-propane sulfonate/sodium acrylate/n-isopropylacrylamide/trimethyl(3-methacrylamidopropyl)ammonium chloride copolymer dimethylmethoxy chromanol glyceryl caprylate egg phospholipids limonene, (+/-)- .beta.-citronellol, (+/-)- sodium hydroxide squalane shea butter ceramide eos sodium lauroyl lactylate carbomer 980 eugenol hexyl cinnamate ensulizole ensulizole titanium dioxide titanium dioxide octocrylene octocrylene zinc oxide zinc oxide radiance superbe day cream translucent ensulizole, octocrylene, titanium dioxide, zinc oxide ceramide ap phytosphingosine glyceryl linolenate pea protein phenoxyethanol glycerin ceramide np cinnamyl alcohol benzyl salicylate polyhydroxystearic acid (2300 mw) olea europaea fruit volatile oil malus domestica whole royal jelly panthenol caprylic/capric/lauric triglyceride diisopropyl adipate linalool, (+)- propanediol .alpha.-tocopherol acetate aluminum hydroxide ammonium acryloyldimethyltaurate/vp copolymer caprylyl glycol glyceryl linoleate carnauba wax cholesterol centella asiatica leaf silk, enzyme hydrolyzed (1000 mw) lecithin, soybean xanthan gum stearic acid sodium 2-acrylamido-2-methyl-1-propane sulfonate/sodium acrylate/n-isopropylacrylamide/trimethyl(3-methacrylamidopropyl)ammonium chloride copolymer dimethylmethoxy chromanol glyceryl caprylate egg phospholipids limonene, (+/-)- .beta.-citronellol, (+/-)- ceramide eos sodium hydroxide squalane shea butter sodium lauroyl lactylate carbomer 980 eugenol hexyl cinnamate zinc oxide zinc oxide ensulizole ensulizole titanium dioxide titanium dioxide octocrylene octocrylene radiance superbe day cream neutral medium ensulizole, octocrylene, titanium dioxide, zinc oxide ceramide ap phytosphingosine glyceryl linolenate pea protein phenoxyethanol glycerin ceramide np cinnamyl alcohol benzyl salicylate olea europaea fruit volatile oil malus domestica whole royal jelly panthenol caprylic/capric/lauric triglyceride diisopropyl adipate linalool, (+)- propanediol .alpha.-tocopherol acetate polyhydroxystearic acid (2300 mw) aluminum hydroxide ammonium acryloyldimethyltaurate/vp copolymer caprylyl glycol carnauba wax cholesterol centella asiatica leaf silk, enzyme hydrolyzed (1000 mw) lecithin, soybean xanthan gum stearic acid glyceryl linoleate sodium 2-acrylamido-2-methyl-1-propane sulfonate/sodium acrylate/n-isopropylacrylamide/trimethyl(3-methacrylamidopropyl)ammonium chloride copolymer dimethylmethoxy chromanol glyceryl caprylate egg phospholipids limonene, (+/-)- .beta.-citronellol, (+/-)- sodium hydroxide squalane shea butter ceramide eos sodium lauroyl lactylate carbomer 980 eugenol hexyl cinnamate ensulizole ensulizole titanium dioxide titanium dioxide octocrylene octocrylene zinc oxide zinc oxide radiance superbe day cream neutral caramel ensulizole, octocrylene, titanium dioxide, zinc oxide ceramide ap phytosphingosine glyceryl linolenate pea protein phenoxyethanol glycerin ceramide np cinnamyl alcohol benzyl salicylate olea europaea fruit volatile oil malus domestica whole royal jelly panthenol caprylic/capric/lauric triglyceride diisopropyl adipate linalool, (+)- propanediol .alpha.-tocopherol acetate polyhydroxystearic acid (2300 mw) aluminum hydroxide ammonium acryloyldimethyltaurate/vp copolymer caprylyl glycol carnauba wax cholesterol centella asiatica leaf silk, enzyme hydrolyzed (1000 mw) lecithin, soybean xanthan gum stearic acid glyceryl linoleate sodium 2-acrylamido-2-methyl-1-propane sulfonate/sodium acrylate/n-isopropylacrylamide/trimethyl(3-methacrylamidopropyl)ammonium chloride copolymer dimethylmethoxy chromanol glyceryl caprylate egg phospholipids limonene, (+/-)- .beta.-citronellol, (+/-)- sodium hydroxide squalane shea butter ceramide eos sodium lauroyl lactylate carbomer 980 eugenol hexyl cinnamate ensulizole ensulizole titanium dioxide titanium dioxide octocrylene octocrylene zinc oxide zinc oxide radiance superbe day cream neutral tan ensulizole, octocrylene, titanium dioxide, zinc oxide ceramide ap phytosphingosine glyceryl linolenate pea protein phenoxyethanol glycerin ceramide np cinnamyl alcohol benzyl salicylate olea europaea fruit volatile oil malus domestica whole royal jelly panthenol caprylic/capric/lauric triglyceride diisopropyl adipate linalool, (+)- propanediol .alpha.-tocopherol acetate polyhydroxystearic acid (2300 mw) aluminum hydroxide ammonium acryloyldimethyltaurate/vp copolymer caprylyl glycol carnauba wax cholesterol centella asiatica leaf silk, enzyme hydrolyzed (1000 mw) lecithin, soybean xanthan gum stearic acid glyceryl linoleate sodium 2-acrylamido-2-methyl-1-propane sulfonate/sodium acrylate/n-isopropylacrylamide/trimethyl(3-methacrylamidopropyl)ammonium chloride copolymer dimethylmethoxy chromanol glyceryl caprylate egg phospholipids limonene, (+/-)- .beta.-citronellol, (+/-)- sodium hydroxide squalane shea butter ceramide eos sodium lauroyl lactylate carbomer 980 eugenol hexyl cinnamate ensulizole ensulizole titanium dioxide titanium dioxide octocrylene octocrylene zinc oxide zinc oxide
Indications and Usage:
Uses helps prevent sunburn * higher spf gives more sunburn protection * 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 and Cautions:
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. stop use and ask a doctor if rash or irratation develos and lasts. you may report effects to fda at 1-800-fda-1088. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Description:
Description radiance superbe day cream broad spectrum spf 35 oil-free sunscreen a latest generation triple age management sunscreen with an immediate ultra-sheer complexion perfecting finish availalbe in 6 ultra-sheer shades + translucent, leaving skin with a radiant, healthy glow. oil free, for all skin types, including sensitive skin. haute custom beauty slu passeig de gracia 41 08047 barcelona haute custom beauty inc austin, tx 78703 usa product of spain www.hautecustombeauty.com airplane image ok gluten free no: parabens, sulphates, mineral oil, silicons, phthalates, pegs, methysilothazzolinone, petroleum derivatives
Package Label Principal Display Panel:
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Radiance superbe day cream nude 72414-001 principal display panel box nude b c
Radiance superbe day cream neutral light 72414-002 neutral light box2 box2 drug facts
Radiance superbe day cream neutral medium 72414-003 neutral medium
Radiance superbe day cream neutral caramel 72414-004 radiance superbe box principal display panel principal display panel
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Radiance superbe day cream neutral bronze 72414-006 principal display panel