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

Australian Gold

Prime Enterprises, Inc.
Prime Enterprises, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

PRINCIPAL DISPLAY PANEL - 88 mL  Tube Label

PRINCIPAL DISPLAY PANEL - 88 mL  Tube Label


Plus Gradual

Self-Tanner

EXOTIC BLEND

#1 Fragrance

Sheer Coverage

45

Faces Sunscreen

WITH INSTANT BRONZER

Broad Spectrum SPF 45

WATER RESISTANT

(80 MINUTES)

Australian

Gold

88 mL / 3 Fl. Oz

Active ingredients

Avobenzone 3 %, Homosalate 15 %,  Octisalate 5 %, and Octocrylene 2.75 %

Purpose

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

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

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

  • use daily to build desired color. This may take several applications.
  • 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
  • wash hands thoroughly after use

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Caramel, Dimethicone, Disodium EDTA, Fragrance (Parfum), Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylisothiazolinone, Olea Europaea (Olive) Fruit Oil, Oleth 10, Phenoxyethanol, Polysilicone-15, Propylene Glycol, Sorbitan Oleate, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopheryl Acetate, Triethanolamine, Trimethylsiloxysilicate, Water (Aqua)

Other information

  • protect this product from excesive heat and direct sun
  • Avoid contact with fabrics, could cause discoloration

Questions or Comments?

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

Australian Gold

Avobenzone,Homosalate, Octisalate, and Octocrylene LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:58443-0032
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 28.9 mg
HOMOSALATE Homosalate 144.3 mg
OCTISALATE OCTISALATE 48.1 mg
OCTOCRYLENE Octocrylene 26.5 mg

Inactive Ingredients

Ingredient Name Strength
CARBOMER COPOLYMER TYPE A
CETYL ALCOHOL
EDETATE DISODIUM
Aloe Vera Leaf
CARAMEL
POLYOXYL 20 CETOSTEARYL ETHER
CITRIC ACID MONOHYDRATE
DIHYDROXYACETONE
L-ERYTHRULOSE
GLYCERYL DILAURATE
METHYLISOTHIAZOLINONE
PHENOXYETHANOL
DIMETHICONE
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2)
HIGH DENSITY POLYETHYLENE
propylene glycol
SILICA DIMETHYL SILYLATE
stearyl alcohol
.ALPHA.-TOCOPHEROL ACETATE
water
GLYCERIN
CALENDULA OFFICINALIS FLOWER
GREEN TEA LEAF
CHAMOMILE
ENGLISH WALNUT

Product Characteristics

Color
brown

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58443-0032-3 88 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-01-25


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