AUSTRALIAN GOLD SPF 30- avobenzone, homosalate, octisalate, octocrylene lotion 
Prime Enterprises, Inc.

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.

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Australian Gold Ultimate Hydration SPF 30 Sunscreen Lotion

Active ingredients

Avobenzone 3 %

Homosalate 7.5 %

Octisalate 5 %

Octocrylene 5 %

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not useon damaged or broken skin.

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

Stop use and ask a doctor ifrash occurs.

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

Directions

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Glycerin, Polyethylene, Phenoxyethanol, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Carbomer, Sodium Hydroxide, Disodium EDTA, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Hydroxypropyl Methylcellulose, Ethylhexylglycerin, Allantoin,Camellia Oleifera (Green Tea) Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Chloride

Other information

Questions or Comments?

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

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

Principal Display Label

AUSTRALIAN GOLD  SPF 30
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0630
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30.09 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE75.23 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50.15 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50.15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
COCOA BUTTER (UNII: 512OYT1CRR)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0630-3100 mL in 1 TUBE; Type 0: Not a Combination Product08/04/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02008/04/2023
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028pack(58443-0630) , manufacture(58443-0630) , label(58443-0630) , analysis(58443-0630)

Revised: 8/2023
Document Id: 0219c8f9-58fd-9fb4-e063-6394a90a2611
Set id: 0219b936-d00c-8f9c-e063-6394a90a6e00
Version: 1
Effective Time: 20230804
 
Prime Enterprises, Inc.