AUSTRALIAN GOLD BROAD SPECTRUM SPF 50- 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 Broad Spectrum SPF 50 Sunscreen Lotion

Active ingredients

Avobenzone 3 %

Homosalate 10 %

Octisalate 5 %

Octocrylene 5 %

Purpose

Sunscreen

Uses

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

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, Glycerin, Polyethylene, Phenoxyethanol, Fragrance, Polysorbate 20, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, 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)

Australian Gold Broad Spectrum SPF 50 Sunscreen Lotion - 237 mL

Principle Display LabelPrinciple Display Label

AUSTRALIAN GOLD  BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0605
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE29.55 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE98.5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE49.25 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE49.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
COCOA BUTTER (UNII: 512OYT1CRR)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
TEA TREE OIL (UNII: VIF565UC2G)  
ALLANTOIN (UNII: 344S277G0Z)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0605-4237 mL in 1 TUBE; Type 0: Not a Combination Product12/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02012/19/2020
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028label(58443-0605) , pack(58443-0605) , manufacture(58443-0605) , analysis(58443-0605)

Revised: 1/2023
Document Id: f1ef6314-42a9-f863-e053-2995a90afe45
Set id: f1ef965f-1fd3-facd-e053-2995a90aa167
Version: 1
Effective Time: 20230110
 
Prime Enterprises, Inc.