NDC 11523-8002 Coppertone Sport Spf 50

Coppertone Sport Aerosol Spray

NDC Product Code 11523-8002

NDC Product Information

Coppertone Sport Spf 50 with NDC 11523-8002 is a a human over the counter drug product labeled by Bayer Healthcare Llc.. The generic name of Coppertone Sport Spf 50 is coppertone sport aerosol spray. The product's dosage form is aerosol, spray and is administered via topical form.

Labeler Name: Bayer Healthcare Llc.

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.

Coppertone Sport 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.

  • OCTISALATE 34.92 mg/mL
  • AVOBENZONE 23.28 mg/mL
  • OCTOCRYLENE 69.83 mg/mL
  • OXYBENZONE 46.55 mg/mL

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.

  • ISOBUTANE (UNII: BXR49TP611)
  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • DIMETHICONE (UNII: 92RU3N3Y1O)

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: Bayer Healthcare Llc.
Labeler Code: 11523
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 11-01-2015 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: 12-31-2019 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.

Coppertone Sport Spf 50 Product Label Images

Coppertone Sport 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

Drug Facts

Drug Facts

Active Ingredients

Active ingredients(To Deliver): Avobenzone 3%, Octisalate 4.5%, Octocrylene 9%, Oxybenzone 6%

Purpose

Sunscreen

Use

  • Helps prevent sunburn

Warnings

For external use onlyFlammable: Do not use near heat, flame, or while smoking.

Do Not Use

Do not use on damaged or broken skin

When Using This Product

  • Keep out of eyes. Rinse with water to remove.use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

Stop Use And Ask A Doctor If

Stop use and ask a doctor if rash occurs

Keep Out Of Reach Of Children

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

Directions

  • Shake well before useapply liberally 15 minutes before sun exposure and rub into skindo not spray directly on face. Spray into hands and apply to faceuse in well-ventilated areasreapply: after 80 minutes of swimming or sweating immediately after towel drying at 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-sleeve shirts, pants, hats, and sunglasseschildren under 6 months: Ask a doctor

Other Information

  • Protect this product from excessive heat and direct sunstore between 20° to 25°C (68° to 77°F)may stain or damage some fabrics or surfaces

Inactive Ingredients

Inactive ingredientsSD Alcohol 40-B (54.5% v/v), Isobutane, Neopentyl Glycol Diheptanoate, Polyester-27, Dimethicone, Tocopherol (Vitamin E), Fragrance.

* Please review the disclaimer below.

Previous Code
11523-7444
Next Code
11523-8003