NDC 13630-0066 Australian Gold Broad Spectrum Spf 15

Avobenzone, Octisalate And Octocrylene

NDC Product Code 13630-0066

NDC Code: 13630-0066

Proprietary Name: Australian Gold Broad Spectrum Spf 15 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, Octisalate And 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

  • 13630 - Prime Packaging, Inc.
    • 13630-0066 - Australian Gold

NDC 13630-0066-4

Package Description: 177 mL in 1 CAN

NDC Product Information

Australian Gold Broad Spectrum Spf 15 with NDC 13630-0066 is a a human over the counter drug product labeled by Prime Packaging, Inc.. The generic name of Australian Gold Broad Spectrum Spf 15 is avobenzone, octisalate and octocrylene. The product's dosage form is spray and is administered via topical form.

Labeler Name: Prime Packaging, 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.

Australian Gold Broad Spectrum Spf 15 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 16.3 mg/mL
  • OCTOCRYLENE 22.4 mg/mL
  • OCTISALATE 40.8 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.

  • DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
  • POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
  • ALCOHOL (UNII: 3K9958V90M)
  • MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
  • DIBUTYL MALEATE (UNII: 4X371TMK9K)

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: Prime Packaging, Inc.
Labeler Code: 13630
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: 01-11-2012 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.

Australian Gold Broad Spectrum Spf 15 Product Label Images

Australian Gold Broad Spectrum Spf 15 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 %, Octisalate 5 %, Octocrylene 2.75 %

Uses

  • Helps prevent sunburnIf used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove. Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinirate. Do not store at temperatures above 1200F

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

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 exposurehold container 4 to 6 inches from the skin to applydo not spray directly on face. Spray on hands and apply to facedo not apply in windy conditionsuse in well-ventilated areasreapply:after 80 minutes of swimming or sweatingimmediately after towel dryingat 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 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 sunglassesChildren under 6 months: Ask a doctor

Inactive Ingredients

Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Menthyl Lactate, Polyester-8, SD Alcohol 40-B, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other Information

  • Protect this product from excesive heat and direct sunavoid spraying on fabrics - could cause discoloration

* Please review the disclaimer below.

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