NDC 69968-0543 Neutrogena Ultra Sheer Face Mist Sunscreen Broad Spectrum Spf 55

Avobenzone, Homosalate, Octisalate, And Octocrylene

NDC Product Code 69968-0543

NDC Code: 69968-0543

Proprietary Name: Neutrogena Ultra Sheer Face Mist Sunscreen Broad Spectrum Spf 55 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Avobenzone, Homosalate, Octisalate, And Octocrylene 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.

NDC Code Structure

  • 69968 - Johnson & Johnson Consumer Inc.
    • 69968-0543 - Neutrogena Ultra Sheer Face Mist Sunscreen Broad Spectrum Spf 55

NDC 69968-0543-3

Package Description: 100 mL in 1 BOTTLE

NDC Product Information

Neutrogena Ultra Sheer Face Mist Sunscreen Broad Spectrum Spf 55 with NDC 69968-0543 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Neutrogena Ultra Sheer Face Mist Sunscreen Broad Spectrum Spf 55 is avobenzone, homosalate, octisalate, and octocrylene. The product's dosage form is spray and is administered via topical form.

Labeler Name: Johnson & Johnson Consumer Inc.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

Product Type: Human Otc Drug 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.

Neutrogena Ultra Sheer Face Mist Sunscreen Broad Spectrum Spf 55 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • AVOBENZONE 30 mg/mL
  • HOMOSALATE 100 mg/mL
  • OCTISALATE 50 mg/mL
  • OCTOCRYLENE 100 mg/mL

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Johnson & Johnson Consumer Inc.
Labeler Code: 69968
FDA Application Number: part352 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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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.

Start Marketing Date: 10-07-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

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Neutrogena Ultra Sheer Face Mist Sunscreen Broad Spectrum Spf 55 Product Label Images