Premium Age Protector Ultra
Inspira Cosmetics Gmbh
Human Otc Drug
NDC 70493-428Premium Age Protector Ultra is a human otc drug labeled by 'Inspira Cosmetics Gmbh'. National Drug Code (NDC) number for Premium Age Protector Ultra is 70493-428. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Premium Age Protector Ultra drug includes Octinoxate - 7.5 g/30mL Octocrylene - 6 g/30mL . The currest status of Premium Age Protector Ultra drug is Active.
Drug Information:
| Drug NDC: | 70493-428 |
| 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: | Premium Age Protector Ultra |
| 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: | Premium Age Protector Ultra |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Inspira Cosmetics Gmbh |
| 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: | OCTINOXATE - 7.5 g/30mL
OCTOCRYLENE - 6 g/30mL
|
| 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 NOT 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 Feb, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 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, 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: | Inspira Cosmetics GmbH
|
| 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: | 4251059310268
|
| UPC stands for Universal Product Code. |
| UNII: | 4Y5P7MUD51
5A68WGF6WM
|
| 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 |
|---|
| 70493-428-02 | 1 JAR in 1 BOX (70493-428-02) / 50 mL in 1 JAR | 15 Feb, 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. |
Product Elements:
Premium age protector ultra premium age protector ultra tocopherol lecithin, soybean ascorbyl palmitate propylene glycol sodium hydroxide phenoxyethanol water butylene glycol methyl glucose sesquistearate potassium aluminum disilicate diethylamino hydroxybenzoyl hexyl benzoate hydrogenated polybutene (1300 mw) glycerin pentylene glycol allantoin aluminum hydroxide oleanolic acid glyceryl caprylate sunflower oil octinoxate octinoxate silicon dioxide bisoctrizole steareth-21 bemotrizinol cetostearyl alcohol glyceryl monostearate phenyl trimethicone vitamin a palmitate annickia chlorantha bark decyl glucoside xanthan gum hydrogen dimethicone (13 cst) titanium dioxide butylated hydroxytoluene tetrasodium glutamate diacetate citric acid monohydrate octocrylene octocrylene propylheptyl caprylate
Package Label Principal Display Panel:
Package label principal display panel 4128 premium age protector ultra spf30 ethylhexyl methoxycinnamate and octocrylene day cream by inspira:cosmetics gbmh disclaimer: most otc drugs are not review and approved by fda; however, they are marketed if they comply with applicable and policies active ingredients: ethylhexyl methoxycinnamate, octocrylene other ingredients: aqua [water], propylheptyl caprylate, , butylene glycol, methyl glucose sesquistearate, diethylamino hydroxybenzoyl hexyl benzoate, hydrogenated polyisobutene, sodium potassium aluminum silicate, glycerin, silica, steareth-21, methylene 8is-benzotriazolyl tetramethylbutylphenol (nano), 8is-ethylhexyloxyphenol methoxyphenyl triazine, cetearyl alcohol, pentylene glycol, glyceryl stearate, phenyl trimethicone, allantoin, retinyl palmitate, enantia chlorantha bark extract, aluminum hydroxide, oleanolic acid, glyceryl caprylate, helianthus annuus (sunflower) co seed oil, xanthan gum, decyl glucoside, lecithin, hydrogen dimethicone, titanium dioxide (nano), ascorbyl palmitate, tocopherol,bht, sodium tetrasodium hydroxide, glutamate parfum diacetate, [fragrance], propylene phenoxyethanol, glycol, citric acid cl t-ct) 77 891 [titanium dioxide] premium age protector ultra