NDC 69968-0068 Neutrogena Cooldry Sport Sunscreen Broad Spectrum Spf30

Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone

NDC Product Code 69968-0068

NDC CODE: 69968-0068

Proprietary Name: Neutrogena Cooldry Sport Sunscreen Broad Spectrum Spf30 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, Octocrylene, 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.

NDC 69968-0068-5

Package Description: 141 g in 1 CAN

NDC Product Information

Neutrogena Cooldry Sport Sunscreen Broad Spectrum Spf30 with NDC 69968-0068 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Neutrogena Cooldry Sport Sunscreen Broad Spectrum Spf30 is avobenzone, homosalate, octisalate, octocrylene, and oxybenzone. The product's dosage form is aerosol, spray and is administered via topical form.

Labeler Name: Johnson & Johnson Consumer Inc.

Dosage Form: Aerosol, Spray - An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents.

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 Cooldry Sport Sunscreen Broad Spectrum Spf30 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/g
  • HOMOSALATE 80 mg/g
  • OCTISALATE 50 mg/g
  • OCTOCRYLENE 40 mg/g
  • OXYBENZONE 50 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.

  • ALCOHOL (UNII: 3K9958V90M)
  • ISOBUTANE (UNII: BXR49TP611)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • DECYLENE GLYCOL (UNII: S57M60MI88)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

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: 09-01-2014 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: 03-25-2022 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’.

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Neutrogena Cooldry Sport Sunscreen Broad Spectrum Spf30 Product Label Images

Neutrogena Cooldry Sport Sunscreen Broad Spectrum Spf30 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

  • Danger: Flammable. Contents under pressure. Do not use near fire, heat or while smoking. Do not puncture or incinerate. Store at temperature below 120°F (48°C). Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

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

Active Ingredients

Avobenzone 3%, Homosalate 8%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn if 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 productkeep away from face to avoid breathing itkeep 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

  • Spray liberally and spread evenly by hand 15 minutes before sun exposurehold container 4-6 inches from the skin to apply. Rub in.do not spray directly into face. Spray on hands and then apply to face. Rub in. do not apply in windy conditions.use in a well-ventilated areareapply: after 80 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hoursSun 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

Alcohol denat., isobutane, octyldodecyl neopentanoate, acrylates/octylacrylamide copolymer, fragrance, dimethicone, tocopheryl acetate, decylene glycol, acrylates/dimethicone copolymer, ethylhexylglycerin

Questions?

800-299-4786; Outside US, dial collect 215-273-8755

* Please review the disclaimer below.