AUSTRALIAN GOLD BOTANICAL 70 BROAD SPECTRUM SPF 70- 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 BOTANICAL 70 NATURAL SPRAY SUNSCREEN

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 5%

Purpose

Sunscreen

Uses

Warnings

For externa l use on ly

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 swa llowed, get medica l help or contact a Poison Contro l Center right away.

F lammab le: Avoid fire, f lame heat and smoking. Contents under pressure. Do not puncture or incinerate. Store at temperatures below 120°F (50°C).

Directions

Inactive ingredients

SD Alcohol 40-B, Trimethoxybenzylidene Pentanedione, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Glycerin, Fragrance, Water, Polyester-8, Tocopheryl Acetate, Eucalyptus Globulus (Eucalyptus) Leaf Extract, Porphyra Umbilicalis Extract, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract

Other information

Questions or comments?

Call toll free 1-885-LIV-GOLD (548-4653)

AUSTRALIAN GOLD BOTANICAL 70 NATURAL SPRAY SUNSCREEN

Principle Display Label

AUSTRALIAN GOLD  BOTANICAL 70 BROAD SPECTRUM SPF 70
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0191
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25.6 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE85.4 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE42.7 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE42.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALCOHOL (UNII: 3K9958V90M)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
TRIMETHOXYBENZYLIDENE PENTANEDIONE (UNII: 322V0ACF25)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0191-4177 mL in 1 CAN; Type 0: Not a Combination Product10/04/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/04/2018
Labeler - Prime Packaging, Inc. (805987059)
Registrant - Prime Packaging, Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028manufacture(13630-0191) , analysis(13630-0191)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging, Inc.805987059label(13630-0191) , pack(13630-0191)

Revised: 11/2021
Document Id: d0d730f8-3403-9f18-e053-2995a90a34c7
Set id: d0d705dd-615d-26fd-e053-2a95a90a4b0b
Version: 1
Effective Time: 20211115
 
Prime Packaging, Inc.