| Drug NDC: | 83021-551 |
| 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: | Anubismed |
| 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: | Spf 50 Broad Spectrum Protection Fluid Emulsion |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Anubis Cosmetics Sl |
| 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: | .ALPHA.-TOCOPHEROL - .006 g/50mL ANHYDROUS CITRIC ACID - .00025 g/50mL ASCORBIC ACID - .00025 g/50mL ASCORBYL PALMITATE - .00125 g/50mL AVOBENZONE - 1.8 g/50mL BEMOTRIZINOL - 1.45 g/50mL BUTYLATED HYDROXYTOLUENE - .0018 g/50mL BUTYLENE GLYCOL - 2.5 g/50mL C20-22 ALCOHOLS - .3375 g/50mL CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) - .075 g/50mL Load more... CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE - .025 g/50mL CHLORPHENESIN - .1 g/50mL DIMETHICONE - 1.25 g/50mL FRAGRANCE 13576 - .3 g/50mL GLYCERIN - .005 g/50mL LINOLEIC ACID - .49725 g/50mL LINOLENIC ACID - .00275 g/50mL OCTINOXATE - 3.5982 g/50mL OCTISALATE - 1.8 g/50mL OCTOCRYLENE - 1.8 g/50mL PHENOXYETHANOL - .35 g/50mL POLY(METHYL METHACRYLATE - 2.1 g/50mL 450000 MW) - .14225 g/50mL POLYETHYLENE GLYCOL 400 - 2.5 g/50mL PROPYLENE GLYCOL - .575 g/50mL SILICON DIOXIDE - .425 g/50mL TITANIUM DIOXIDE - .22 g/50mL TROMETHAMINE - 27.55 mL/50mL WATER - |
| 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 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: | 15 Oct, 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: | 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, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. | |
| Manufacturer Name: | ANUBIS COSMETICS SL |
| 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. | |
| NUI: | N0000175833 N0000175835 N0000175980 N0000008556 N0000175089 N0000193618 M0001797 N0000010282 N0000185370 N0000175629 N0000184306 N0000185001 M0000728 M0009417 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | H4N855PNZ1 XF417D3PSL PQ6CK8PD0R QN83US2B0N G63QQF2NOX PWZ1720CBH 1P9D0Z171K 3XUS85K0RA O4M0347C6A 71DD5V995L Load more... 0A5MM307FC I670DAL4SZ 92RU3N3Y1O 5EM498GW35 PDC6A3C0OX 9KJL21T0QJ 0RBV727H71 4Y5P7MUD51 4X49Y0596W 5A68WGF6WM HIE492ZZ3T B697894SGQ 6DC9Q167V3 ETJ7Z6XBU4 15FIX9V2JP 023C2WHX2V 059QF0KO0R |
| 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. | |
| Pharmacologic Class MOA: | Acidifying Activity [MoA] Calcium Chelating Activity [MoA] |
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. | |
| Pharmacologic Class EPC: | Calculi Dissolution Agent [EPC] Anti-coagulant [EPC] Vitamin C [EPC] Non-Standardized Chemical Allergen [EPC] |
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. | |
| Pharmacologic Class PE: | Decreased Coagulation Factor Activity [PE] Skin Barrier Activity [PE] Increased Histamine Release [PE] Cell-mediated Immunity [PE] Increased IgG Production [PE] |
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. | |
| Pharmacologic Class CS: | Ascorbic Acid [CS] Allergens [CS] Glycerol [CS] |
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. | |
| Pharmacologic Class: | Acidifying Activity [MoA] Allergens [CS] Anti-coagulant [EPC] Ascorbic Acid [CS] Calcium Chelating Activity [MoA] Calculi Dissolution Agent [EPC] Cell-mediated Immunity [PE] Decreased Coagulation Factor Activity [PE] Glycerol [CS] Increased Histamine Release [PE] Increased IgG Production [PE] Non-Standardized Chemical Allergen [EPC] Skin Barrier Activity [PE] Vitamin C [EPC] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 83021-551-50 | 50 mL in 1 BOTTLE (83021-551-50) | 15 Oct, 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. | ||||
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