AUSTRALIAN GOLD SPF 15 SUNSCREEN- avobenzone, octisalate, octocrylene 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.

----------

Australian Gold Ultimate Hydration 15 Spray Gel Sunscreen

Active Ingredients

Avobenzone 2%

Octisalate 5%

Octocrylene 2%

Purpose

Sunscreen

Uses

Warnings

  • 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

Water/Aqua/Eau, Aloe Barbadensis Leaf Juice, Glycerin, Butylphthalimide,Phenoxyethanol,Isopropylphthalimide, Fragrance (Parfum), Acrylates/C12-22 Alkyl Methacrylate Copolymer, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20,Trimethylsiloxysilicate, Disodium EDTA, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Tocopheryl Acetate, Hydroxypropyl Methylcellulose, Ethylhexylglycerin, Propylene Glycol, Sodium Hydroxide, 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 GLD ULTIMATE HYDRATION 15 SPRAY GEL SUNSCREEN

Principle Display LabelPrinciple Display Label

AUSTRALIAN GOLD  SPF 15 SUNSCREEN
avobenzone, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0613
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE19.4 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE49 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE19.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
WATER (UNII: 059QF0KO0R)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
TEA TREE OIL (UNII: VIF565UC2G)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0613-4237 mL in 1 BOTTLE; Type 0: Not a Combination Product12/11/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02012/11/2019
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0613) , manufacture(58443-0613) , label(58443-0613) , analysis(58443-0613)

Revised: 3/2023
Document Id: f60649ca-19a7-8ca8-e053-2a95a90a4cb2
Set id: f60649bc-18f8-515a-e053-2995a90a5c4f
Version: 1
Effective Time: 20230303
 
Prime Enterprises Inc.