Label: AUSTRALIAN GOLD BROAD SPECTRUM SPF 30- avobenzone, octisalate, octocrylene, and oxybenzone gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 58443-0150-4 - Packager: Prime Enterprises, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 17, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
-
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), 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 Ferdinandiaria (Kakadum Plum) Fruit Extract, Tocopheryl Acetate, Triethanolamine, Trimethylsiloxysilicate, Water (Aqua)
- Other information
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
-
INGREDIENTS AND APPEARANCE
AUSTRALIAN GOLD BROAD SPECTRUM SPF 30
avobenzone, octisalate, octocrylene, and oxybenzone gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0150 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 29.4 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 73.5 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 49 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 26.95 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 19.6 mg in 1 mL Inactive Ingredients Ingredient Name Strength C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y) BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P) ALOE VERA LEAF (UNII: ZY81Z83H0X) N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E) ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329) DIMETHICONE (UNII: 92RU3N3Y1O) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) EDETATE DISODIUM (UNII: 7FLD91C86K) SUNFLOWER OIL (UNII: 3W1JG795YI) HYPROMELLOSES (UNII: 3NXW29V3WO) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) OLIVE OIL (UNII: 6UYK2W1W1E) OLETH-10 (UNII: JD797EF70J) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSILICONE-15 (UNII: F8DRP5BB29) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) KAKADU PLUM (UNII: 0ZQ1D2FDLI) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0150-4 237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 04/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2015 Labeler - Prime Enterprises, Inc. (101946028) Registrant - Prime Enterprises, Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 label(58443-0150) , pack(58443-0150) , manufacture(58443-0150) , analysis(58443-0150)