Rvr90 Hydrating
Zinc Oxide
Ultraceuticals Us, Llc
Human Otc Drug
NDC 73122-063Rvr90 Hydrating also known as Zinc Oxide is a human otc drug labeled by 'Ultraceuticals Us, Llc'. National Drug Code (NDC) number for Rvr90 Hydrating is 73122-063. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Rvr90 Hydrating drug includes . The currest status of Rvr90 Hydrating drug is Active.
Drug Information:
| Drug NDC: | 73122-063 |
| 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 Hydrating |
| 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: | 20 Dec, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 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, 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: | 9352207004673
|
| 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 |
|---|
| 73122-063-01 | 1 KIT in 1 KIT (73122-063-01) * 149.9 mL in 1 BOTTLE * 29.9 mL in 1 BOTTLE * 75.1 mL in 1 BOTTLE * 99.9 mL in 1 BOTTLE (73122-064-01) | 20 Dec, 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 hydrating zinc oxide ultra uv protective mineral defence spf 50 zinc oxide alkyl (c12-15) benzoate octyldodecyl neopentanoate caprylyl glycol caprylyl trisiloxane carnosine sodium chloride propanediol tetrasodium glutamate diacetate dimethicone niacinamide zinc oxide zinc oxide polymethylsilsesquioxane (4.5 microns) tridecyl salicylate butyloctyl salicylate methylpropanediol allantoin polyethylene glycol 500 silicon dioxide isododecane triceteareth-4 phosphate phenylpropanol water caffeine levomenol sodium hydroxide ultra brightening foaming cleanser coconut oil caprylhydroxamic acid caprylyl glycol linolenic acid .beta.-citronellol, (r)- cocamidopropyl betaine glycol stearate lauric acid sodium chloride sodium lactate niacinamide lime oil, cold pressed lemon oil, cold pressed lavender oil water tocopherol sodium methyl cocoyl taurate sodium cocoyl glycinate glycerin coconut acid panthenol linoleic acid sodium hydroxide potassium sorbate propanediol edetate disodium anhydrous bergamot oil geranium oil, algerian type sodium benzoate cucumber geraniol limonene, (+)- linalool, (+/-)- ultra b2 hydrating serum hyaluronate sodium sodium pyrrolidone carboxylate urea glycerin potassium sorbate niacinamide panthenol sorbic acid salicylic acid cucumber trehalose propanediol water benzyl alcohol ultra moisturiser cream phenylpropanol glycerin methylpropanediol steareth-20 sorbitan isostearate edetate disodium anhydrous shea butter dimethicone hyaluronate sodium peg-75 stearate coconut oil vanillin sodium hydroxide linoleic acid tocopherol cetyl alcohol glyceryl monobehenate glyceryl monostearate linolenic acid xanthan gum ceteth-20 polysorbate 60 caprylyl glycol urea cholesterol ceramide np lactic acid alkyl (c12-15) benzoate sodium pyrrolidone carboxylate hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (45000 mpa.s at 1%) water cyclomethicone 5 sodium lactate
Indications and Usage:
Stop use and ask a doctor if 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 generously 15 minutes before sun exposure and reapply at least every 2 hours. children under 6 months of age: ask a doctor. 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 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. â 2 p.m. ⢠wear long-sleeved shirts, pants, hats, and sunglasses â¢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 hydrating boost skin's hydration levels for smoother, more youthful looking skin facial cleanser 5.07 fl. oz. facial serum 1.01 fl. oz. facial moisturizer 2.54 fl. oz. sunscreen 3.38 fl. oz. cosmetics bag hydrating rvr kit