FDA Label for Australian Gold Broad Spectrum Spf 30

View Indications, Usage & Precautions

Australian Gold Broad Spectrum Spf 30 Product Label

The following document was submitted to the FDA by the labeler of this product Prime Enterprises, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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