FDA.reportPublic FDA data

Australian Gold

Manufacturer
Prime Enterprises, Inc.
Effective date
2020-01-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:46:00

Label at a glance#

ProductAustralian Gold BROAD SPECTRUM SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure9 sections

Indications and 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

Dosage and administration

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 decease 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, e...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3 %, Homosalate 10 %, Octisalae 5 %, Octocrylene 2.75 %,and Oxybenzone 4 %

OTC - PURPOSE SECTION

Purpose

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

OTHER SAFETY INFORMATION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTHER SAFETY INFORMATION

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 decease 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

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Disodium EDTA, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylisothiazolinone, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polyethylene, Polysilicone-15, Polysorbate 20, Propylene Glycol, Sorbitan Oleate, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

Other information

SPL UNCLASSIFIED SECTION

  • protect this product from excesive heat and direct sun

OTC - QUESTIONS SECTION

Questions or Comments?

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

PRINCIPAL DISPLAY PANEL - 237 mL  Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 237 mL Bottle LabelPRINCIPAL DISPLAY PANEL - 237 mL Bottle Label


EXOTIC BLEND

Baby

50

Lotion

Sunscreen

Moisture Max

BROAD SPECTRUM SPF 50

WATER RESISTANT

(80 MINUTES)

Australian Gold

237 mL / 8 Fl. Oz

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
HOMOSALATEACTIVE INGREDIENTV06SV4M95S1
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
HOMOSALATEACTIVE MOIETYV06SV4M95S1
OCTISALATEACTIVE MOIETY4X49Y0596W1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
3-BUTYLPHTHALIDEINACTIVE INGREDIENT822Q956KGM1
ALLANTOININACTIVE INGREDIENT344S277G0Z1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ1
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27E1
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT809Y72KV361
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRR1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B01
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR71
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
ISOPROPYLPHTHALIMIDEINACTIVE INGREDIENT1J1MM833291
KAKADU PLUMINACTIVE INGREDIENT0ZQ1D2FDLI1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFA1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYSILICONE-15INACTIVE INGREDIENTF8DRP5BB291
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD561
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI1
TEA TREE OILINACTIVE INGREDIENTVIF565UC2G1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-007958443-0079-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
3-BUTYLPHTHALIDE822Q956KGMIACT
ISOPROPYLPHTHALIMIDE1J1MM83329IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
EDETATE DISODIUM7FLD91C86KIACT
SUNFLOWER OIL3W1JG795YIIACT
HYPROMELLOSES3NXW29V3WOIACT
TEA TREE OILVIF565UC2GIACT
OLIVE OIL6UYK2W1W1EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
POLYSILICONE-15F8DRP5BB29IACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITAN MONOOLEATE06XEA2VD56IACT
COCOA BUTTER512OYT1CRRIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
KAKADU PLUM0ZQ1D2FDLIIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 375 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCREAM / TOPICAL0.1 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / NASAL0.1 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSPONGE / TOPICAL11 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7CAPSULE / ORAL10 mgExact identifier — unii candidate
18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7SUPPOSITORY / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, DELAYED RELEASE / ORAL79 mgExact identifier — unii candidate
27 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSOLUTION / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL, METERED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHTABLET, EXTENDED RELEASE / ORAL4.2 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHLOTION / TOPICAL2000 mgExact identifier — unii candidate
28 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOJELLY / TOPICALNAExact identifier — unii candidate
27 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR60 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSOLUTION / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSOLUTION / TOPICAL15 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / AURICULAR (OTIC)10 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOGRANULE, FOR SUSPENSION / ORAL1.7 mgExact identifier — unii candidate
27 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION, EXTENDED RELEASE / ORAL1000 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, METERED / RECTALADJ PHExact identifier — unii candidate
22 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, FILM COATED / ORAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii candidate
81 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKPOWDER / TOPICAL0.02 mg/mgExact identifier — unii candidate
22 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKEMULSION / TOPICAL0.5 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, COATED / ORAL0.21 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSHAMPOO, SUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAMUSCULAR4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii candidate
77 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7TABLET, COATED / ORAL25 mgExact identifier — unii candidate
18 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / NASAL2 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / OPHTHALMIC0.06 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAVENOUS7 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / RECTAL27 mgExact identifier — unii candidate
81 equally ranked IID candidates
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36GEL / TRANSDERMAL30 mgExact identifier — unii candidate
6 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSUSPENSION/ DROPS / OPHTHALMIC3 mgExact identifier — unii candidate
27 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY, METERED / NASAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
CARBOMER 940CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EEMULSION / TOPICAL6 mgExact identifier — unii candidate
9 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ded262d4-50f8-8689-e053-2a95a90af755b4aa9d4c-c170-4645-85f7-db99624188772022-05-12WarningsExact identifier
spl set id: b4aa9d4c-c170-4645-85f7-db9962418877

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.