AUSTALIAN GOLD BROAD SPECTRUM SPF 15 SUNSCREEN- octisalate, avobenzone, 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 Instant Bronzer Broad Spectrum SPF 15 Sun Screen

Active Ingredients

Avobenzone 2.0%

Octisalate 5.0%

Octocrylene 2%

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

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

Other Information

Questions or Comments?

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

Australian Gold INSTANT BRONZER Broad Spectrum SPF 15

Principle Display LabelPrinciple Display Label

AUSTALIAN GOLD  BROAD SPECTRUM SPF 15 SUNSCREEN
octisalate, avobenzone, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0603
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SUNFLOWER OIL (UNII: 3W1JG795YI)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ALLANTOIN (UNII: 344S277G0Z)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
CARAMEL (UNII: T9D99G2B1R)  
TEA TREE OIL (UNII: VIF565UC2G)  
COCOA BUTTER (UNII: 512OYT1CRR)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
Product Characteristics
Colorbrown (Caramel) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0603-4237 mL in 1 BOTTLE; Type 0: Not a Combination Product10/17/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02010/17/2019
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0603) , manufacture(58443-0603) , label(58443-0603) , analysis(58443-0603)

Revised: 1/2023
Document Id: f1da0b28-3ff8-49c9-e053-2995a90aa4fa
Set id: f1da65b8-ea46-62ca-e053-2a95a90a78b3
Version: 1
Effective Time: 20230109
 
Prime Enterprises Inc.