AUSTRALIAN GOLD SPF 50- avobenzone, homosalate, octisalate, octocrylene spray 
Prime Packaging 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 SPF 50 Continuous Sunscreen Spray

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.

Flammable: Avoid fire, flame, heat, and smoking. Contents under pressure. Do not puncture or incinerate. Do no store at temperatures above 120°F (50°C).

Directions

Inactive Ingredients

SD Alcohol 40-B, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Fragrance, Polyester-8, Helianthus Annuus (Sunflower) Seed Oil, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil

Other Information

Question or comments?

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

Australian Gold SPF 50 Continuous Sunscreen Spray

Principle Display Label

AUSTRALIAN GOLD  SPF 50
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0269
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25.08 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE83.6 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE41.8 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE41.8 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TEA TREE OIL (UNII: VIF565UC2G)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALCOHOL (UNII: 3K9958V90M)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Product Characteristics
Coloryellow (Light Yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0269-4203 mL in 1 CAN; Type 0: Not a Combination Product11/18/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02011/18/2019
Labeler - Prime Packaging Inc. (805987059)
Registrant - Prime Packaging Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc101946028manufacture(13630-0269) , analysis(13630-0269)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging Inc.805987059pack(13630-0269) , label(13630-0269)

Revised: 2/2023
Document Id: f5653201-87cd-3ec6-e053-2995a90ace5a
Set id: f5652c81-d8e0-4f31-e053-2a95a90a5d37
Version: 1
Effective Time: 20230223
 
Prime Packaging Inc.