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  3. NDC Product Code: 58274-008 Brush On Block Nude Tint Protective Lip Oil Broad Spectrum Spf 32

NDC 58274-008 Brush On Block Nude Tint Protective Lip Oil Broad Spectrum Spf 32

Titanium Dioxide,Zinc Oxide Liquid Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

    1. Product Information
    2. Product Packages
    3. What is NDC 58274-008?
    4. Brush On Block Nude Tint Protective Lip Oil Broad Spectrum Spf 32 Uses
    5. Active Ingredients
    6. Active Ingredients UNII Codes
    7. Inactive Ingredients UNII Codes
    8. Pharmacologic Classes

Product Information

NDC Product Code:
58274-008
Proprietary Name:
Brush On Block Nude Tint Protective Lip Oil Broad Spectrum Spf 32
Non-Proprietary Name: [1]
Titanium Dioxide, Zinc Oxide
Substance Name: [2]
Titanium Dioxide; Zinc Oxide
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Labeler Name: [5]
    Spf Ventures, Llc
    Labeler Code:
    58274
    Product Label ID:
    0210a2db-ae0f-42df-898d-c60107154f87
    FDA Application Number: [6]
    part352
    Marketing Category: [8]
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date: [9]
    02-01-2019
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 58274-008-01

    Package Description: 1 TUBE in 1 CARTON / 6.8 mL in 1 TUBE

    Product Details

    What is NDC 58274-008?

    The NDC code 58274-008 is assigned by the FDA to the product Brush On Block Nude Tint Protective Lip Oil Broad Spectrum Spf 32 which is a human over the counter drug product labeled by Spf Ventures, Llc. The generic name of Brush On Block Nude Tint Protective Lip Oil Broad Spectrum Spf 32 is titanium dioxide, zinc oxide. The product's dosage form is liquid and is administered via topical form. The product is distributed in a single package with assigned NDC code 58274-008-01 1 tube in 1 carton / 6.8 ml in 1 tube. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Brush On Block Nude Tint Protective Lip Oil Broad Spectrum Spf 32?

    Apply liberally 15 minutes before sun exposureReapply at least every 2 hoursUse a water resistant sunscreen if swimming or sweatingChildren under 6 months: Ask a doctor   Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:   Limit time in the sun, especially from 10 a.m. – 2 p.m.   Wear long-sleeve shirt, pants, hats, and sunglasses

    What are Brush On Block Nude Tint Protective Lip Oil Broad Spectrum Spf 32 Active Ingredients?

    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 Brush On Block Nude Tint Protective Lip Oil Broad Spectrum Spf 32 UNII Codes?

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

    Which are Brush On Block Nude Tint Protective Lip Oil Broad Spectrum Spf 32 Inactive Ingredients 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:

    Which are the Pharmacologic Classes for Brush On Block Nude Tint Protective Lip Oil Broad Spectrum Spf 32?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".