NDC 69968-0088 Neutrogena Healthy Skin 3 In 1 Concealer For Eyes Sunscreen Broad Spectrum Spf20 - Fair

Titanium Dioxide

NDC Product Code 69968-0088

NDC CODE: 69968-0088

Proprietary Name: Neutrogena Healthy Skin 3 In 1 Concealer For Eyes Sunscreen Broad Spectrum Spf20 - Fair 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: Titanium Dioxide 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.
    • 69968-0088 - Neutrogena Healthy Skin 3 In 1 Concealer For Eyes

NDC 69968-0088-1

Package Description: 1 TUBE in 1 BLISTER PACK > 10.4 g in 1 TUBE

NDC Product Information

Neutrogena Healthy Skin 3 In 1 Concealer For Eyes Sunscreen Broad Spectrum Spf20 - Fair with NDC 69968-0088 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Neutrogena Healthy Skin 3 In 1 Concealer For Eyes Sunscreen Broad Spectrum Spf20 - Fair is titanium dioxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Johnson & Johnson Consumer Inc.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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 Healthy Skin 3 In 1 Concealer For Eyes Sunscreen Broad Spectrum Spf20 - Fair 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.

  • TITANIUM DIOXIDE 95 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.

  • WATER (UNII: 059QF0KO0R)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • TALC (UNII: 7SEV7J4R1U)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • DEANOL (UNII: 2N6K9DRA24)
  • BORON NITRIDE (UNII: 2U4T60A6YD)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
  • SODIUM METHYLESCULETIN ACETATE (UNII: HGU5120054)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • TYROSINE (UNII: 42HK56048U)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • CYCLOMETHICONE 6 (UNII: XHK3U310BA)
  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
  • MAGNESIUM CARBONATE (UNII: 0E53J927NA)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)

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: 05-24-2013 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 08-31-2021 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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 Healthy Skin 3 In 1 Concealer For Eyes Sunscreen Broad Spectrum Spf20 - Fair 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

Active Ingredients

Titanium Dioxide 9.5%

Purpose

Sunscreen

Uses

  • Helps prevent sunburnif used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

  • 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 use:apply liberally 15 minutes before sun exposurereapply at least every 2 hoursuse a water resistant sunscreen if swimming or sweatingSun 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 other sun protection measures including:limit time in the sun, especially from 10 a.m. - 2 p.m.wear long-sleeved shirts, pants, hats, and sunglasseschildren under 6 months of age: Ask a doctor.

Other Information

  • Protect this product from excessive heat and direct sunmay stain some fabrics

Inactive Ingredients

Water, cyclopentasiloxane, talc, butylene glycol, ethylhexyl palmitate, C12-15 alkyl benzoate, polyglyceryl-4 diisostearate/ polyhydroxystearate/ sebacate, dimethyl MEA, cetyl dimethicone, boron nitride, cetyl PEG/PPG-10/1 dimethicone, citric acid, ozokerite, magnesium sulfate, BHT, aloe barbadensis leaf extract, camellia sinensis leaf extract, saccharomyces lysate extract, sodium methylesculetin acetate, caprylyl glycol, tyrosine, hydrogenated polyisobutene, silica, alumina, cyclohexasiloxane, 1,2 hexanediol, polyhydroxystearic acid, aluminum starch octenylsuccinate, acrylates copolymer, magnesium carbonate, dimethicone, polymethylsilsesquioxane, propylene glycol, triethoxycaprylylsilane, methylisothiazolinone, fragrance. May contain: titanium dioxide, iron oxide

* Please review the disclaimer below.