NDC 43979-446 Outback Series 2-in-1 Sunscreen

NDC Product Code 43979-446

NDC 43979-446-01

Package Description: 3 mL in 1 POUCH

NDC 43979-446-03

Package Description: 75 mL in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Outback Series 2-in-1 Sunscreen with NDC 43979-446 is a product labeled by Elmore Oil Company Pty Ltd. The generic name of Outback Series 2-in-1 Sunscreen is . The product's dosage form is and is administered via form.

Labeler Name: Elmore Oil Company Pty Ltd

Dosage Form: -

Product Type: 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.

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.

  • EUCALYPTUS POLYBRACTEA LEAF OIL (UNII: J1XGA6WROO)
  • LEPTOSPERMUM PETERSONII LEAF OIL (UNII: N37UWG52T3)
  • CITRONELLA OIL (UNII: QYO8Q067D0)
  • TEA TREE OIL (UNII: VIF565UC2G)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Elmore Oil Company Pty Ltd
Labeler Code: 43979
Start Marketing Date: 07-01-2013 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: 12-31-2017 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: I 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.

Outback Series 2-in-1 Sunscreen Product Label Images

Outback Series 2-in-1 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 Ingrdient

Octyl Methoxycinnamate - 7.5% Avobenzone - 1.3% Zinc Oxide - 9.5%

Purpose

Sunscreen 30+

Indication And Usage

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.

Dosage And Administration

Apply liberally 15 minutes before sun exposure reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours.

Warnings

For external use only. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if a rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact the Poison Control Center right away.Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF or 15 or higher and other sun protection measures including: limit time in the sun, especially between 10 a.m – 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses. children under 6 months: Ask a doctor.

Inactive Ingredients

Actilastin 1000, Melaleuca Alternifolia, Eucalyptus Polybractea, Citronella, Leptospermum Petersonii, Vanilla

Keep Out Of Reach Of Children

Keep Out of Reach of Children

* Please review the disclaimer below.