Australian Gold
FDA Label NDC 58443-0081

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 58443-0081). 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 principal display panel - 150 ml  bottle label, active ingredients, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Principal Display Panel - 150 Ml  Bottle Label

Principal Display Panel (150 mL Bottle Label)

Principal Display Panel (150 mL Bottle Label)

Australian Gold

HELLO

KITTY

Mineral

Sunscreen Lotion

Summer Berry

30

BROAD SPECTRUM SPF 30

Water Resistant (80 minutes)

5 FL OZ (150 mL)

Active Ingredients

Titanium Dioxide 3 % and Zinc Oxide 4 %

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measure (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 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

Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aluminum Hydroxide, Artemisia Princeps (Yomogi) Extract, Buddleja Davidii (Butterfly Bush) Extract, C12-15 Alkyl Benzoate, Ceteareth-20, Cetyl Alcohol, Citric Acid, Dibutyl Adipate, Dimethicone, Fragrance (Parfum), Glycerin, Hexyl Laurate, Magnesium Aluminum Silicate, Methylisothiazolinone, PEG-12 Dimethicone, Phenoxyethanol, Polyglyceryl-3 Distearate, Propylene Glycol, Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, Triethoxycaprylylsilane, Water (Aqua), Xanthan Gum

Other Information

  • protect this product from excesive heat and direct sun

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