NDC 69968-0569 Neutrogena Cooldry Sport Sunscreen Broad Spectrum Spf 50

Avobenzone, Homosalate, Octisalate, And Octocrylene

NDC Product Code 69968-0569

NDC Code: 69968-0569

Proprietary Name: Neutrogena Cooldry Sport Sunscreen Broad Spectrum Spf 50 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.
    • 69968-0569 - Neutrogena Cooldry Sport Sunscreen Broad Spectrum Spf 50

NDC 69968-0569-5

Package Description: 141 g in 1 CAN

NDC Product Information

Neutrogena Cooldry Sport Sunscreen Broad Spectrum Spf 50 with NDC 69968-0569 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 Spf 50 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 Cooldry Sport Sunscreen Broad Spectrum Spf 50 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 100 mg/g
  • OCTISALATE 50 mg/g
  • OCTOCRYLENE 100 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)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • POLYESTER-7 (UNII: 0841698D2F)
  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)

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: 09-01-2019 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 Cooldry Sport Sunscreen Broad Spectrum Spf 50 Product Label Images

Neutrogena Cooldry Sport Sunscreen Broad Spectrum Spf 50 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

Otc - Purpose

Active ingredients PurposeAvobenzone 3%SunscreenHomosalate 10%SunscreenOctisalate 5%SunscreenOctocrylene 10%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 out of eyes. Rinse with water to remove. keep away from face to avoid breathing it

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 exposure hold 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 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 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 sunglasses children under 6 months of age: Ask a doctor

Other Information

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

Inactive Ingredients

Alcohol Denat., Isobutane, Dicaprylyl Carbonate, Polyester-7, Acrylates/Octylacrylamide Copolymer, Neopentyl Glycol Diheptanoate, Fragrance, Tocopheryl Acetate

* Please review the disclaimer below.