Starter Set Oily/normal Skin
Zinc Oxide
Ultraceuticals Pty Limited
Human Otc Drug
NDC 10028-020Starter Set Oily/normal Skin also known as Zinc Oxide is a human otc drug labeled by 'Ultraceuticals Pty Limited'. National Drug Code (NDC) number for Starter Set Oily/normal Skin is 10028-020. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Starter Set Oily/normal Skin drug includes . The currest status of Starter Set Oily/normal Skin drug is Active.
Drug Information:
| Drug NDC: | 10028-020 |
| 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: | Starter Set Oily/normal Skin |
| 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 Pty Limited |
| 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: | 01 Mar, 2020 |
| 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 PTY LIMITED
|
| 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: | 9352207002549
|
| 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 |
|---|
| 10028-020-01 | 1 KIT in 1 PACKAGE, COMBINATION (10028-020-01) * 200 mL in 1 BOTTLE * 30 mL in 1 BOTTLE * 75 mL in 1 BOTTLE * 100 mL in 1 BOTTLE (10028-021-01) | 01 Mar, 2020 | 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:
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:
Starter set oily/normal skin zinc oxide ultra protective protective mineral defence spf 50 zinc oxide allantoin dimethicone isododecane caprylyl trisiloxane carnosine methylpropanediol octyldodecyl neopentanoate caffeine polymethylsilsesquioxane (11 microns) niacinamide phenylpropanol alkyl (c12-15) benzoate propanediol silicon dioxide sodium chloride sodium hydroxide triceteareth-4 phosphate tridecyl salicylate water polyethylene glycol 500 tetrasodium glutamate diacetate caprylyl glycol zinc oxide zinc oxide ultra balancing gel cleanser xanthan gum citrus maxima fruit rind oil citric acid monohydrate edetate disodium edetic acid glycerin formic acid maltodextrin laureth-4 benzyl alcohol aloe vera leaf sodium hydroxide glycol distearate edetate sodium edetic acid potassium sorbate oatmeal propanediol limonene, (+)- cocamidopropyl betaine sodium lauroyl sarcosinate decyl glucoside magnesium aluminum silicate sodium lauroyl lactylate water sorbic acid panthenol salicylic acid sodium benzoate sodium chloride .alpha.-tocopherol acetate cucumber ultra b2 hydrating serum niacinamide hyaluronate sodium propanediol water panthenol benzyl alcohol urea sodium pyrrolidone carboxylate pyrrolidone carboxylic acid glycerin cucumber trehalose salicylic acid potassium sorbate sorbic acid ultra hydrating lotion cholesterol dimethicone ammonium acryloyldimethyltaurate, dimethylacrylamide, lauryl methacrylate and laureth-4 methacrylate copolymer, trimethylolpropane triacrylate crosslinked (45000 mpa.s) cetearyl isononanoate tocopherol ammonium acryloyldimethyltaurate/vp copolymer cetyl palmitate glyceryl monostearate methylpropanediol dicaprylyl carbonate decyl oleate tert-butyl alcohol lactic acid olive oil decyl esters squalene hyaluronate sodium urea linoleic acid sodium pyrrolidone carboxylate pyrrolidone carboxylic acid linolenic acid aloe vera leaf cetostearyl alcohol water glycerin benzoic acid citric acid monohydrate xanthan gum polyoxyl 20 cetostearyl ether soybean oil ceteareth-12 caprylyl glycol sodium phosphate, dibasic, anhydrous phenylpropanol sodium hydroxide maltodextrin sodium lactate lecithin, soybean ceramide np
Indications and Usage:
Stop use and ask a doctor if rash occurs or irritation develops and lasts.
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 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 sunglassesof age: ask a doctor. reapply after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours
Package Label Principal Display Panel:
Starter set oil/ normal skin begin your journey with ultraceuticals starter packs ultra uv protective mineral defence spf 50+ 100ml ultra balancing cleanser 200ml ultra b2 hydrating serum 30ml ultra hydrating lotion 75ml oily normal setr