Australian Gold
FDA Label NDC 58443-0017

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 58443-0017). 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, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Avobenzone 2 %, Homosalate 7.5 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 2 %

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

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 decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
      • limit time in 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

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Fragrance(Parfum), Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Melaleuca Alternifolia (Tea Tree) leaf Oil, Methylisothiazolinone, Methylparaben, Olea Europaea (Olive ) Fruit Oil, Polyethylene, Polysilicone-15, Polysorbate 20, Propylene Glycol, Camellia Sinensis ( Green Tea) Leaf Extract, Propylparaben, Sorbitan Oleate, Sorbitol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

Other Information

  • protect this product from excesive heat and direct sun

Principal Display Panel - 237 Ml  Bottle Label


EXOTIC BLEND

#1 Fragrance

KIDS

30

Lotion

Sunscreen

Moisture Max

BROAD SPECTRUM SPF 30

WATER RESISTANT

(80 MINUTES)

Australian

Gold

237 mL / 8 Fl. Oz

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