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

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Australian Gold SPF 30 Sport Ultra Chill Lotion

Purpose

Sunscreen

Active Ingredients

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocrylene 5%

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 doctorif 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, C12-15 Alkyl Benzoate, Glycerin, Aluminum Starch Octenylsuccinate, Polyethylene, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Sodium Hydroxide, Carbomer, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Olea Europaea (Olive) Fruit Oil, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Tetrasodium Glutamate Diacetate, Ethylhexylglycerin, Allantoin, Menthol, Camellia Oleifera (Green Tea) Leaf Extract, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Cetyl Phosphate, Melaleuca Alternifolia (Tea Tree) Leaf Oil

Other Information

Questions or Comments?

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

Australian Gold SPF 30 Lotion Sport Ultra Chill

Principal Display Label

AUSTRALIAN GOLD  SPF 30 SPORT ULTRA CHILL
octisalate, avobenzone, homosalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0602
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE74.48 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE49.65 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE29.79 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE49.65 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
CETYL PHOSPHATE (UNII: VT07D6X67O)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL (UNII: L7T10EIP3A)  
TEA TREE OIL (UNII: VIF565UC2G)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
COCOA BUTTER (UNII: 512OYT1CRR)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
ALLANTOIN (UNII: 344S277G0Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0602-330 mL in 1 PACKET; Type 0: Not a Combination Product10/14/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02010/14/2019
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0602) , manufacture(58443-0602) , label(58443-0602) , analysis(58443-0602)

Revised: 1/2024
Document Id: 0fb305eb-6e62-14c4-e063-6294a90a3146
Set id: 0fb2eebd-8297-ff90-e063-6294a90a6dab
Version: 1
Effective Time: 20240124
 
Prime Enterprises Inc.