Rvr90 Brighten
Zinc Oxide
Ultraceuticals Us, Llc
Human Otc Drug
NDC 73122-061Rvr90 Brighten also known as Zinc Oxide is a human otc drug labeled by 'Ultraceuticals Us, Llc'. National Drug Code (NDC) number for Rvr90 Brighten is 73122-061. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Rvr90 Brighten drug includes . The currest status of Rvr90 Brighten drug is Active.
Drug Information:
| Drug NDC: | 73122-061 |
| 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: | Rvr90 Brighten |
| 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: | Zinc Oxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Ultraceuticals Us, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| 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: | |
| 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: | 15 Nov, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 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, 2024 |
| 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: | Ultraceuticals US, LLC
|
| 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: | 9352207004666
|
| UPC stands for Universal Product Code. |
| UNII: | |
| 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 |
|---|
| 73122-061-01 | 1 KIT in 1 KIT (73122-061-01) * 149.9 mL in 1 BOTTLE * 29.8 mL in 1 BOTTLE * 75.1 mL in 1 BOTTLE * 99.9 mL in 1 TUBE (73122-062-01) | 15 Nov, 2021 | 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.
Product Elements:
Rvr90 brighten zinc oxide ultra uv protective mineral defence spf 50 zinc oxide tetrasodium glutamate diacetate isododecane alkyl (c12-15) benzoate caffeine dimethicone caprylyl glycol triceteareth-4 phosphate tridecyl salicylate water sodium chloride zinc oxide zinc oxide caprylyl trisiloxane carnosine methylpropanediol niacinamide octyldodecyl neopentanoate polymethylsilsesquioxane (4.5 microns) propanediol allantoin phenylpropanol silicon dioxide levomenol sodium hydroxide ultra brightening foaming cleanser linoleic acid geraniol limonene, (+)- caprylhydroxamic acid edetate disodium anhydrous .beta.-citronellol, (r)- water sodium cocoyl glycinate glycol stearate sodium lactate propanediol sodium hydroxide glycerin panthenol niacinamide coconut oil sodium methyl cocoyl taurate cocamidopropyl betaine coconut acid bergamot oil potassium sorbate sodium chloride lauric acid lemon oil, cold pressed geranium oil, algerian type lavender oil cucumber caprylyl glycol sodium benzoate tocopherol ultra brightening serum water lactic acid citric acid monohydrate niacinamide salicylic acid hydroxyethyl cellulose, unspecified sodium sulfite sodium phosphate phenylethyl alcohol alcohol sodium hydroxide sodium metabisulfite caprylhydroxamic acid glycerin melissa officinalis flowering top bellis perennis whole hydroxyresveratrol caprylyl glycol sodium phosphate, dibasic, anhydrous polysorbate 60 ultra brightening moisturiser cream geranium oil, algerian type shea butter steareth-20 tocopherol water niacinamide lavender oil santalum spicatum oil phenoxyethanol alkyl (c12-15) benzoate glycerin rumex occidentalis whole octadecenedioic acid xanthan gum ceteth-20 polysorbate 60 eucalyptus radiata leaf oil caprylyl trisiloxane glyceryl monobehenate cetyl alcohol glyceryl monostearate hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 mpa.s at 1.5%) peg-75 stearate dimethicone/vinyl dimethicone crosspolymer (soft particle) orange oil, cold pressed bergamot oil edetate disodium anhydrous pogostemon cablin leaf oil hyaluronate sodium caprylyl glycol sorbitan isostearate ylang-ylang oil phenylpropanol dimethicone linoleic acid squalane methylpropanediol
Indications and Usage:
Stop use and ask a doctor if skin rash occurs.
Warnings:
Warnings do not use: on damaged or broken skin. when using this product keep out of eyes. rinse with water to remove. for external use only
Dosage and Administration:
Directions apply liberally 15 minutes before sun exposure and at least every 2 hours children under 6 months of age: 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 spectrum spf value of 15 or higher and other sun protection measures including: limit your time in the sun, especially from 10 a.m. - 2p.m. wear long-sleeved shirts, pants, hats, and sunglasses reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours
Package Label Principal Display Panel:
Transform your skin in 90 days brighten enhance skin's luminosity and clarity face cleanser 5.07 fl. oz. facial serum 1.01 fl. oz. facial moisturizer 2.54 fl. oz. sunscreen 3.38 fl. oz. cosmetics bag rvr90 brighten