Fitish Spf 50 Face Stick
NDC 84417-002

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 84417-002?
  4. Fitish Spf 50 Face Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

Fitish Spf 50 Face is a UNAPPROVED DRUG OTHER-approved product labeled by Fitish Holdings, Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a stick for cutaneous administration. This product entry covers the primary NDC 84417-002 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
84417-002
Proprietary Name:
Fitish Spf 50 Face
Non-Proprietary Name: [1]
Fitish Spf 50 Face
Substance Name: [2]
Octinoxate; Octocrylene; Octisalate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Stick - A dosage form prepared in a relatively long and slender often cylindrical form.
Administration Route(s): [4]
Cutaneous - Administration to the skin.

Labeler & Regulatory Data

Labeler Name: [5]
Fitish Holdings, Llc
Labeler Code:
84417
Product Label ID:
1c44a572-59e6-c3c5-e063-6394a90a0e24
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
06-26-2024
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 84417-002?

The NDC code 84417-002 is assigned by the FDA to the product Fitish Spf 50 Face. This pharmaceutical product is labeled by Fitish Holdings, Llc and is currently categorized as listed product. The medication is a stick administered via cutaneous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 84417-002-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Apply directly to clean skin 15 minutes before sun exposure and anywhere you want extra glow. Reapply after40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. Can be usedon body as well.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 othersun protection measures including limiting time in the sun, especially from 10 a.m.-2 p.m. and wear long-sleevedshirts, pants, hats and sunglasses

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".