Sunday Riley Sulfur Acne Treatment Mask
Sulfur
Sunday Riley Modern Skincare, Llc
Human Otc Drug
NDC 73001-340Sunday Riley Sulfur Acne Treatment Mask also known as Sulfur is a human otc drug labeled by 'Sunday Riley Modern Skincare, Llc'. National Drug Code (NDC) number for Sunday Riley Sulfur Acne Treatment Mask is 73001-340. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Sunday Riley Sulfur Acne Treatment Mask drug includes Sulfur - .1 g/mL . The currest status of Sunday Riley Sulfur Acne Treatment Mask drug is Active.
Drug Information:
| Drug NDC: | 73001-340 |
| 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: | Sunday Riley Sulfur Acne Treatment Mask |
| 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: | Sulfur |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Sunday Riley Modern Skincare, Llc |
| 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: | SULFUR - .1 g/mL
|
| 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: | 08 Jan, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 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: | part333D |
| 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: | Sunday Riley Modern Skincare, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1053330
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0817494011944
|
| UPC stands for Universal Product Code. |
| UNII: | 70FD1KFU70
|
| 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 |
|---|
| 73001-340-60 | 1 TUBE in 1 BOX (73001-340-60) / 60 mL in 1 TUBE | 08 Jan, 2017 | 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:
Purpose acne treatment
Product Elements:
Sunday riley sulfur acne treatment mask sulfur sulfur sulfur water bentonite niacinamide isoamyl laurate cetyl ethylhexanoate hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 mpa.s at 1.5%) olive oil glycereth-8 esters polyglyceryl-2 caprate acacia sorbitan isostearate polysorbate 60 zinc pidolate manuka oil 4-terpineol, (+/-)- glycyrrhizinate dipotassium allantoin silicon dioxide polysorbate 20 polyoxyl 40 hydrogenated castor oil edetate disodium anhydrous tocopherol alcohol azadirachta indica leaf amber azadirachta indica flower coccinia grandis fruit ocimum basilicum flowering top eggplant turmeric corallina officinalis phenoxyethanol caprylyl glycol chlorphenesin
Indications and Usage:
Uses for the management of acne penetrates pores to control blackheads helps prevent new acne blemishes and blackheads from forming
Warnings:
Warnings for external use only. when using this product using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin if this occurs, only one medication should be used apply only to areas with acne do not use on broken skin large areas of the skin keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions cleanse the skin thoroughly before applying medication. for rinse off treatment, apply to dry skin. leave on for 20 minutes and rinse off thoroughly with water. for leave-on, overnight treatment, apply to affected area, and rinse off thoroughly in the morning with water. use 2-3 times a week. if going outside, use a sunscreen. if bothersome dryness or peeling occurs, reduce application use.
Package Label Principal Display Panel:
Packaging image description