NDC 70000-0413 Cardinal Health Leader Spf30 General Protection Sunscreen

Avobenzone, Oxybenzone. Homosalate, Octisalate, Octocrylene

NDC Product Code 70000-0413

NDC Code: 70000-0413

Proprietary Name: Cardinal Health Leader Spf30 General Protection Sunscreen 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, Oxybenzone. 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.
    • 70000-0413 - Cardinal Health Leader Spf30 General Protection Sunscreen

NDC 70000-0413-1

Package Description: 237 mL in 1 BOTTLE

NDC Product Information

Cardinal Health Leader Spf30 General Protection Sunscreen with NDC 70000-0413 is a a human over the counter drug product labeled by Cardinal Health, Inc.. The generic name of Cardinal Health Leader Spf30 General Protection Sunscreen is avobenzone, oxybenzone. homosalate, octisalate, octocrylene. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Cardinal Health, Inc.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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 Spf30 General Protection Sunscreen 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 20 mg/mL
  • OXYBENZONE 20 mg/mL
  • HOMOSALATE 105 mg/mL
  • OCTISALATE 50 mg/mL
  • OCTOCRYLENE 20 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.

  • WATER (UNII: 059QF0KO0R)
  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • SORBITOL (UNII: 506T60A25R)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • OCTADECENE (UNII: H5ZUQ6V4AK)
  • BARIUM SULFATE (UNII: 25BB7EKE2E)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • CARBOMER 934 (UNII: Z135WT9208)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • COCOS NUCIFERA WHOLE (UNII: 245J88W96L)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
  • DISODIUM EDTA-COPPER (UNII: 6V475AX06U)

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: 04-03-2019 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.

Cardinal Health Leader Spf30 General Protection Sunscreen Product Label Images

Cardinal Health Leader Spf30 General Protection Sunscreen 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 2.0%Homosalate 10.5%Octisalate 5.0%Octocrylene 2.0%Oxybenzone 2.0%

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 onlyDo not use • on damaged or broken skin.When using this product • keep out of eyes. Rinse with water to remove

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.

Directions

• apply liberally 15 minutes before sun exposure• reapply:• after 80 minutes of swimming or sweating• immediately after towel drying• at least every 2 hours• children under 6 months of age: ask a doctor• 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 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 sunglasses

Other Information

• protect this product from excessive heat and direct sun• may stain or damage some fabrics/materials or surfaces

Inactive Ingredients

Water,Sorbitan isostearate, Sorbitol, Triethanolamine,Polyglyceryl-3 distearate,Stearic acid,Octadecene/MA Copolymer,barium sulfate,benzyl alcohol,VP/eiocosene copolymer,dimethicone, carbomer,methylparaben,aloebarbedensis leaf extract,SIMMONDSIA CHINENSIS (jojoba) SEED oil,tocopherol (vitamin E),cocos nucifera (coconut oil), mineral oil, propylparaben,fragrance, disodium EDTA.

* Please review the disclaimer below.

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