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

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

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:13630-0180
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25.89 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE86.3 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE43.15 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE43.15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TEA TREE OIL (UNII: VIF565UC2G)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALCOHOL (UNII: 3K9958V90M)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
WATER (UNII: 059QF0KO0R)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0180-4197 mL in 1 CAN; Type 0: Not a Combination Product10/12/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/12/2020
Labeler - Prime Packaging Inc. (805987059)
Registrant - Prime Packaging Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc101946028manufacture(13630-0180) , analysis(13630-0180)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging Inc.805987059pack(13630-0180) , label(13630-0180)

Revised: 8/2021
Document Id: ca52411a-4d62-1311-e053-2995a90a4542
Set id: ca5259ae-9ffe-4711-e053-2995a90a9cca
Version: 1
Effective Time: 20210824
 
Prime Packaging Inc.