AUSTRALIAN GOLD BROAD SPECTRUM SPF 50 SUNSCREEN- octisalate, avobenzone, octocrylene, homosalate spray 
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 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 or irritation develops and lasts.

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, Caramel,Phenoxyethanol, Fragrance, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Dimethicone,Acrylates/C10-30 Alkyl Acrylate Crosspolymer,Polysorbate 20,Trimethylsiloxysilicate,Helianthus Annuus (Sunflower) Seed Oil,Olea Europaea (Olive) Fruit Oil,Tocopheryl Acetate, Tetrasodium Glutamate Diacetate, Hydroxypropyl Methylcellulose, Ethylhexylglycerin, Sodium Hydroxide, Propylene Glycol, Sorbitan Oleate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Chloride

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:58443-0611
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE49.6 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE29.7 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE49.6 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE99.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
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)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARAMEL (UNII: T9D99G2B1R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TEA TREE OIL (UNII: VIF565UC2G)  
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
Colorbrown (Caramel) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0611-4237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/26/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02010/26/2017
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0611) , manufacture(58443-0611) , label(58443-0611) , analysis(58443-0611)

Revised: 3/2023
Document Id: f601d5d1-869e-27cc-e053-2a95a90add2b
Set id: f601d78f-f260-28a9-e053-2a95a90a2cb7
Version: 1
Effective Time: 20230303
 
Prime Enterprises Inc.