Active Ingredients
Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 5 %
Australian Gold
FDA Label NDC 58443-0566
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prime Enterprises, Inc. for the product Australian Gold (NDC 58443-0566). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 only
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
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 product is 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
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decease 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
- children under 6 months: Ask a doctor
Inactive Ingredients
Water, Glycerin, Polyethylene, Phenoxyethanol, Fragrance, Polysorbate 20, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Sodium Hydroxide, Disodium EDTA, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Olea Europaea (Olive) Fruit Oil, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Ethylhexylglycerin, Allantoin, Aloe Barbadensis Leaf Juice, Camellia Oleifera (Green Tea) Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract
Other Information
- Protect this product from excesive heat and direct sun
- May stain some fabrics or surfaces
Questions Or Comments?
Call toll free 1-855-LIV-GOLD (548-4653)
Australian Gold Broad Spectrum Spf 50 Sunscreen Lotion - 3.7 L
Principle Display Label (Label)
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