NDC 69968-0548 Neutrogena Norwegian Formula Lip Moisturizer Sunscreen Spf15

Octinoxate And Oxybenzone

NDC Product Code 69968-0548

NDC CODE: 69968-0548

Proprietary Name: Neutrogena Norwegian Formula Lip Moisturizer Sunscreen Spf15 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: Octinoxate And Oxybenzone 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.
    • 69968-0548 - Neutrogena Norwegian Formula Lip Moisturizer Sunscreen Spf15

NDC 69968-0548-1

Package Description: 1 CYLINDER in 1 BLISTER PACK > 4 g in 1 CYLINDER

NDC Product Information

Neutrogena Norwegian Formula Lip Moisturizer Sunscreen Spf15 with NDC 69968-0548 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Neutrogena Norwegian Formula Lip Moisturizer Sunscreen Spf15 is octinoxate and oxybenzone. The product's dosage form is lipstick and is administered via topical form.

Labeler Name: Johnson & Johnson Consumer Inc.

Dosage Form: Lipstick - A waxy solid, usually colored cosmetic, in stick form for the lips.

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 Norwegian Formula Lip Moisturizer Sunscreen Spf15 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.

  • OCTINOXATE 75 mg/g
  • OXYBENZONE 40 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • CASTOR OIL (UNII: D5340Y2I9G)
  • CORN OIL (UNII: 8470G57WFM)
  • CERESIN (UNII: Q1LS2UJO3A)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

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.
  • 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: 10-30-2019 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’.

* Please review the disclaimer below.

Neutrogena Norwegian Formula Lip Moisturizer Sunscreen Spf15 Product Label Images

Neutrogena Norwegian Formula Lip Moisturizer Sunscreen Spf15 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Distributed by:JOHNSON & JOHNSON CONSUMER INC.Skillman, NJ 08558

Otc - Purpose

Active ingredientPurposeOctinoxate 7.5%SunscreenOxybenzone 4%Sunscreen

Use

  • Helps prevent sunburn

Skin Cancer/Skin Aging Alert

  • Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.For external use only

Otc - Do Not Use

  • Do not use on damaged or broken skin

Otc - When Using

  • When using this product keep out of eyes. Rinse with water to remove

Otc - Stop Use

  • Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • For Sunscreen useapply liberally 15 minutes before sun exposure. Ensure complete coverage to the lipuse a water resistant sunscreen if swimming or sweatingreapply at least every 2 hours Children under 6 months of age: Ask a doctor

Other Information

  • Protect this product from excessive heat and direct sun

Inactive Ingredients

Ricinus Communis (Castor) Seed Oil, Zea Mays (Corn) Oil, Ozokerite, Petrolatum, Beeswax, Ethylhexyl Palmitate, Paraffin, Stearyl Alcohol, Copernicia Cerifera (Carnauba) Wax, BHT

Questions?

800-299-4786; Outside US dial collect US, 215-273-8755 or www.neutrogena.com

* Please review the disclaimer below.