NDC 58443-0348 Australian Gold Spf 4 Sunscreen

Avobenzone, Octocrylene

NDC Product Code 58443-0348

NDC 58443-0348-4

Package Description: 237 mL in 1 BOTTLE

NDC Product Information

Australian Gold Spf 4 Sunscreen with NDC 58443-0348 is a a human over the counter drug product labeled by Prime Enterprises Inc.. The generic name of Australian Gold Spf 4 Sunscreen is avobenzone, octocrylene. The product's dosage form is spray and is administered via topical form.

Labeler Name: Prime Enterprises 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 Spf 4 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 9.24 mg/mL
  • OCTOCRYLENE 9.24 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.

  • COCONUT OIL (UNII: Q9L0O73W7L)
  • CARROT SEED OIL (UNII: 595AO13F11)
  • DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
  • ISOPROPYL LINOLEATE (UNII: 4MW1E9AT4H)
  • KUKUI NUT OIL (UNII: TP11QR7B8R)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • HEXADECENE (MIXED ISOMERS) (UNII: 38H8547VP0)
  • ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • CETYL ACETATE (UNII: 4Q43814HXS)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • PYRROLIDONE (UNII: KKL5D39EOL)
  • KAKADU PLUM (UNII: 0ZQ1D2FDLI)

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: Prime Enterprises Inc.
Labeler Code: 58443
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: 09-25-2020 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.

Australian Gold Spf 4 Sunscreen Product Label Images

Australian Gold Spf 4 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 1%Octocrylene 1%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn

Warnings

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

Otc - Do Not Use

  • Do not use on damaged or broken skin

Otc - When Using

  • When using this product keep away from face to avoid breathing it. Keep out of eyes.
  • Rinse with water to remove.

Otc - Ask Doctor

  • Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Shake well before use • apply liberally 15 minutes before sun exposure and rub into skin • hold container 4 to 6 inches from the skin to apply • do not spray directly into face. Spray on hands then apply to face • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months: Ask a doctor

Inactive Ingredients

Acetylated Lanolin Alcohol, Aleurites Moluccana Seed Oil, Aloe Barbadensis Leaf Extract, BHT, Caprylic/Capric Triglyceride, Cetyl Acetate, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Seed Oil, Diethylhexyl Syringylidene-Malonate, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Lanolate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Terminalia Ferdinandiana (Kakadu Plum) Seed Oil, Tocopheryl Acetate, VP/Hexadecene Copolymer

Other Information

  • Protect this product from excessive heat and direct sun • May stain some fabrics or surfaces

* Please review the disclaimer below.