NDC 70000-0074 Cardinal Health Leader Sport Sunscreen Spf 30

Avobenzone, Homosalate, Octisalate, Octocrylene

NDC Product Code 70000-0074

NDC CODE: 70000-0074

Proprietary Name: Cardinal Health Leader Sport Sunscreen Spf 30 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 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

  • 70000 - Cardinal Health, Inc.
    • 70000-0074 - Cardinal Health Leader Sport Sunscreen Spf 30

NDC 70000-0074-1

Package Description: 156 g in 1 CAN

NDC Product Information

Cardinal Health Leader Sport Sunscreen Spf 30 with NDC 70000-0074 is a a human over the counter drug product labeled by Cardinal Health, Inc.. The generic name of Cardinal Health Leader Sport Sunscreen Spf 30 is avobenzone, homosalate, octisalate, octocrylene. The product's dosage form is spray and is administered via topical form.

Labeler Name: Cardinal Health, 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.

Cardinal Health Leader Sport Sunscreen Spf 30 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 20 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)

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: Cardinal Health, Inc.
Labeler Code: 70000
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: 12-10-2020 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: 12-31-2021 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.

Cardinal Health Leader Sport Sunscreen Spf 30 Product Label Images

Cardinal Health Leader Sport Sunscreen Spf 30 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

Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 2.0%




• helps prevent sunburn • if used as directed with other sun protectionmeasures (see Directions), decreases the risk of skin cancer and early skin agingcaused by the sun


For external use onlyFlammable:• do not use near heat, flame or while smoking• avoid long term storage above 104°F (40°C)

Do Not Use

• on damaged or broken skin.

When Using This Product

• keep out of eyes. Rinse with water to remove.• Keep away from face to avoid breathing it. • do not puncture or incinerate.Contents under pressure. • do not store at temperatures above 120° F.

Stop Use And Ask A Doctor If

• rash occurs.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


• Spray liberally and spread evenly by hand 15 minutes before sun exposure• Hold can 4-6 inches away from the skin to apply• Do not spray directly into face. Spray into hands then apply to face• Do not apply in windy conditions• Use in a well-ventilated areareapply:• after 80 minutes of swimming or sweating• immediately after towel drying• at least every 2 hours• children under 6 months of age: Ask a doctorSun Protection Measures. Spending time in the sun increases yourrisk of skin cancer and early skin aging. To decrease this risk, regularly usea sunscreen with a Broad Spectrum SPF value of 15 or higher and othersun protection measures including:• limit time in the sun, especially from 10 a.m. - 2 p.m.• wear long-sleeved shirts, pants, hats, and sunglasses

Other Information

• protect the product in this container from excessive heat and direct sun• may stain or damage some fabrics, materials or surfaces

Inactive Ingredients

Alcohol denat., butyloctyl salicylate, acrylates/octylacrylamide copolymer, panthenol, tocopherol (vitamin E), fragrance, stearoxytrimethylsilane, caprylic/capric triglyceride, glycerin


Cardinal Health Leader Sport Sunscreen SPF 30 Clear Continuous Spray5.5 oz (156 g)NDC 70000-0074-1

* Please review the disclaimer below.