NDC 79903-007 Tanning Sunscreen Uvb Protection Dry Oil Equate

Avobenzone, Homosalate, Octisalate

NDC Product Code 79903-007

NDC CODE: 79903-007

Proprietary Name: Tanning Sunscreen Uvb Protection Dry Oil Equate 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 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

  • 79903 - Wal-mart Stores Inc.
    • 79903-007 - Tanning Sunscreen Uvb Protection Dry Oil

NDC 79903-007-37

Package Description: 156 g in 1 CAN

NDC Product Information

Tanning Sunscreen Uvb Protection Dry Oil Equate with NDC 79903-007 is a a human over the counter drug product labeled by Wal-mart Stores Inc.. The generic name of Tanning Sunscreen Uvb Protection Dry Oil Equate is avobenzone, homosalate, octisalate. The product's dosage form is aerosol, spray and is administered via topical form.

Labeler Name: Wal-mart Stores 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.

Tanning Sunscreen Uvb Protection Dry Oil Equate 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.

  • HOMOSALATE 100 mg/g
  • OCTISALATE 50 mg/g
  • AVOBENZONE 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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)

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.
  • 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: Wal-mart Stores Inc.
Labeler Code: 79903
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: 08-31-2020 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.

Tanning Sunscreen Uvb Protection Dry Oil Equate Product Label Images

Tanning Sunscreen Uvb Protection Dry Oil Equate 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 10.0%, Octisalate 5.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn • Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early signs of aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

Warnings

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.

Directions

• 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 area

• 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

Other Information

• protect this product from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

Inactive Ingredients

Alcohol denat., tridecyl salicylate, acrylates/octylacrylamide copolymer, glycerin, mineral oil, fragrance.

Label

Equate Tanning Sunscreen UVB Protection SPF 15 Spray Dry Oil5.5 oz (156 g)NDC 79903-007-37

* Please review the disclaimer below.