Rvr90 Clear
Zinc Oxide
Ultraceuticals Us, Llc
Human Otc Drug
NDC 73122-071Rvr90 Clear also known as Zinc Oxide is a human otc drug labeled by 'Ultraceuticals Us, Llc'. National Drug Code (NDC) number for Rvr90 Clear is 73122-071. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Rvr90 Clear drug includes . The currest status of Rvr90 Clear drug is Active.
Drug Information:
| Drug NDC: | 73122-071 |
| 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 Clear |
| 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: | 03 Jan, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 11 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: | M020 |
| 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: | |
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| 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 |
|---|
| 73122-071-01 | 1 KIT in 1 KIT (73122-071-01) * 75.1 mL in 1 BOTTLE * 49.9 mL in 1 TUBE (73122-074-01) * 149.9 mL in 1 BOTTLE (73122-073-01) * 99.9 mL in 1 TUBE (73122-072-01) | 03 Jan, 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. |
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.
Purpose uses for treatment of acne clears acne blemishes
Product Elements:
Rvr90 clear 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 clear foaming cleanser salicylic acid sodium hydroxide allantoin sodium pyrrolidone carboxylate edetate disodium dehydroacetic acid lactic acid sodium lauroyl lactylate water polysorbate 20 methylpropanediol decyl glucoside hamamelis virginiana top water mandelic acid clove oil santalum spicatum oil sodium benzoate benzoic acid phenoxyethanol peg-120 methyl glucose dioleate cocamidopropyl betaine caprylyl glycol salicylic acid salicylic acid disodium lauriminodipropionate tocopheryl phosphates phenylpropanol niacinamide eucalyptus oil sodium chloride ultra clear treatment salicylic acid hydrated silica dehydroacetic acid water niacinamide dimethicone methylpropanediol cetostearyl alcohol maltodextrin benzoic acid phenylpropanol tribehenin peg-20 esters salicylic acid salicylic acid arginine polypropylene glycol 15 stearyl ether glycerin mandelic acid diethylene glycol monoethyl ether disodium lauriminodipropionate tocopheryl phosphates bentonite caprylyl glycol allantoin levomenol sodium pyrrolidone carboxylate carbomer interpolymer type a (allyl sucrose crosslinked) ammonium acryloyldimethyltaurate, dimethylacrylamide, lauryl methacrylate and laureth-4 methacrylate copolymer, trimethylolpropane triacrylate crosslinked (45000 mpa.s) xanthan gum edetate disodium anhydrous eucalyptus oil santalum spicatum oil phenoxyethanol clove oil aloe vera leaf tert-butyl alcohol uitra hydrating lotion glycerin urea polyoxyl 20 cetostearyl ether tocopherol linoleic acid dicaprylyl carbonate decyl oleate aloe vera leaf cholesterol cetostearyl alcohol olive oil decyl esters lecithin, soybean soybean oil ammonium acryloyldimethyltaurate/vp copolymer lactic acid sodium phosphate, dibasic, anhydrous tert-butyl alcohol cetearyl isononanoate squalene hyaluronate sodium cetyl palmitate ceramide np ceteareth-12 ammonium acryloyldimethyltaurate, dimethylacrylamide, lauryl methacrylate and laureth-4 methacrylate copolymer, trimethylolpropane triacrylate crosslinked (45000 mpa.s) water sodium hydroxide glyceryl monostearate maltodextrin phenylpropanol caprylyl glycol citric acid monohydrate methylpropanediol dimethicone benzoic acid xanthan gum
Indications and Usage:
Stop use and ask a doctor if skin rash occurs.
Indications - ultra clear foaming cleanser stop use and ask a doctor: if skin irritation becomes severe
Warnings:
Warnings- ultra clear foaming cleanser warnings for external use only. when using this product: skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. if irritation occurs, only use one topical acne medication at a time.
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 directions clean the skin thoroughly before applying this product. cover the entire affected area with a thin layer and rinse thoroughly one to three times daily because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. if dryness or peeling occurs, reduce application to once a day or every other day. if going outside, apply sunscreen after using this product. if irritation or sensitivity develops, stop use of both product and ask a doctor.
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 clear visibly decongest and smooth skin while reducing future breakouts acne facial cleanser 5.07 fl. oz. acne treatment lotion 1.69 fl. oz. facial moisturizer 2.54 fl. oz. sunscreen 3.38 fl. oz. cosmetic bag belly band clear