AUSTRALIAN GOLD BROAD SPECTRUM SPF 50 SUNSCREEN- octisalate, avobenzone, octocrylene, homosalate spray 
Prime Enterprises Inc.

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Australian Gold INSTANT BRONZER Broad Spectrum SPF 50 Sun Screen

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 away from face to avoid breathing it. 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, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, Caramel, Dimethicone, Ethylhexylglycerin, Fragrance, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Sorbitan Oleate, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tetrasodium Glutamate Diacetate, Tocopheryl Acetate, Trimethylsiloxysilicate, Water

Other Information

Questions or Comments?

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

Australian Gold INSTANT BRONZER Broad Spectrum SPF 50

Principle Display LabelPrinciple Display Label

AUSTRALIAN GOLD  BROAD SPECTRUM SPF 50 SUNSCREEN
octisalate, avobenzone, octocrylene, homosalate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0570
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE49.5 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE29.7 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE49.5 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE99 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
GLYCERIN (UNII: PDC6A3C0OX)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARAMEL (UNII: T9D99G2B1R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
TEA TREE OIL (UNII: VIF565UC2G)  
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
Product Characteristics
Colorbrown (Caramel) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0570-4237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/26/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02007/26/2021
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0570) , manufacture(58443-0570) , label(58443-0570) , analysis(58443-0570)

Revised: 5/2024
Document Id: 178eeda2-cdc4-a059-e063-6294a90a5d4f
Set id: e819ab31-412d-5bed-e053-2a95a90a307d
Version: 3
Effective Time: 20240503
 
Prime Enterprises Inc.