Australian Gold description, usages, side effects, indications, overdosage, supplying and lots more!

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Australian Gold

Prime Enterprises, Inc.
Prime Enterprises, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

PRINCIPAL DISPLAY PANEL - 237 mL  Bottle Label

Australian Gold
EXOTIC BLEND

#1 Fragrance

15

Spray Gel

Sunscreen

CLEAR

BROAD SPECTRUM SPF 15

WATER RESISTANT

(80 MINUTES)

Australian

Gold

237 mL / 8 Fl. Oz

Active ingredients

Avobenzone 2 %, Octocrylene 2.75 %, Octisalate 5 %, and Oxybenzone 0.5 %

Purpose

Purpose

Sunscreen

Australian Gold 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

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

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

Directions

  • spray liberally and spread evenly 15 minutes before sun exposure
  • do not spray directly into face. Use in a well-ventilated area
  • 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 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/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, Dimethicone, 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, Oleth-10, Polysilicone-15, Propylene Glycol, Propylparaben, Sorbitan Oleate, Tocopheryl Acetate, Triethanolamine, Trimethylsiloxysilicate, Water (Aqua), Yellow 6 (CI 15985)

Australian Gold Other information

  • protect this product from excessive heat and direct sun

Questions or Comments?

Call toll free 1-855-LIV-GOLD (548-4653)

Australian Gold

Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:58443-0027
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 19.7 mg
OCTISALATE OCTISALATE 49 mg
OCTOCRYLENE Octocrylene 26.9 mg
OXYBENZONE OXYBENZONE 4.9 mg

Inactive Ingredients

Ingredient Name Strength
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER
Aloe Vera Leaf
3-BUTYLPHTHALIDE
ISOPROPYLPHTHALIMIDE
DIMETHICONE
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)
EDETATE DISODIUM
SUNFLOWER OIL
HYPROMELLOSES
MELALEUCA ALTERNIFOLIA LEAF
METHYLISOTHIAZOLINONE
METHYLPARABEN
olive oil
oleth-10
Polysilicone-15
propylene glycol
PROPYLPARABEN
SORBITAN MONOOLEATE
.ALPHA.-TOCOPHEROL ACETATE
TROLAMINE
water
FD&C YELLOW NO. 6

Product Characteristics

Color
orange

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58443-0027-4 237 in 1 BOTTLE, SPRAY

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-03-28


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