NDC 69039-224 Sun Bum Spf 15 Premium Moisturizing Sunscreen

Avobenzone,Homosalate,Octisalate,Octocrylene Spray Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
69039-224
Proprietary Name:
Sun Bum Spf 15 Premium Moisturizing Sunscreen
Non-Proprietary Name: [1]
Avobenzone, Homosalate, Octisalate, Octocrylene
Substance Name: [2]
Avobenzone; Homosalate; Octisalate; Octocrylene
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Spray - A liquid minutely divided as by a jet of air or steam.
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]
    Sun Bum, Llc
    Labeler Code:
    69039
    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]
    08-26-2017
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 69039-224-01

    Package Description: 177 mL in 1 CAN

    Product Details

    What is NDC 69039-224?

    The NDC code 69039-224 is assigned by the FDA to the product Sun Bum Spf 15 Premium Moisturizing Sunscreen which is a human over the counter drug product labeled by Sun Bum, Llc. The generic name of Sun Bum Spf 15 Premium Moisturizing Sunscreen is avobenzone, homosalate, octisalate, octocrylene. The product's dosage form is spray and is administered via topical form. The product is distributed in a single package with assigned NDC code 69039-224-01 177 ml in 1 can . 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 Sun Bum Spf 15 Premium Moisturizing Sunscreen?

    Hold container 4 to 6 inches from the skin to apply.Spray liberally and spread evenly by hand 15 minutes before sun exposure.Do not spray directly into face. Spray on hands then apply to face.Do not apply in windy conditions. Use in well-ventilated area.Reapply: After 80 minutes of swimming or sweating.Immediately after towel drying. At least every 2 hours.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 of 15 or higher and other sun protection measures, including: Limit time in the sun, especially from 10 am - 2 pm.Wear long-sleeve shirts, pants, hats, and sunglasses.Children under 6 months: Ask a doctor.

    What are Sun Bum Spf 15 Premium Moisturizing Sunscreen 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 Sun Bum Spf 15 Premium Moisturizing Sunscreen UNII Codes?

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

    Which are Sun Bum Spf 15 Premium Moisturizing Sunscreen 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:

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    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".