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

Other information

Questions or Comments?

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

Australian Gold Broad Spectrum SPF 50 Sunscreen Lotion - 3.7 L

Principle Display Label

AUSTRALIAN GOLD  BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0566
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE29.43 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE98.1 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE49.1 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE49.1 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)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
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:58443-0566-93700 mL in 1 TUBE; Type 0: Not a Combination Product04/20/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02004/20/2022
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028label(58443-0566) , pack(58443-0566) , manufacture(58443-0566) , analysis(58443-0566)

Revised: 9/2022
Document Id: e805e7be-5a96-0d5a-e053-2a95a90aa694
Set id: e805e88b-32a2-fb28-e053-2995a90ace99
Version: 1
Effective Time: 20220906
 
Prime Enterprises, Inc.