AUSTRALIAN GOLD BROAD SPECTRUM SPF 15- avobenzone, 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.

----------

AUSTRALIAN GOLD ULTIMATE HYDRATION 15 CONTINUOUS SPRAY SUNSCREEN

Active Ingredients

Avobenzone 2%

Octisalate 5%

Octocrylene 2%

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 swalowed, 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. Store at temperatures below 120°F (50°C).

Directions

Inactive ingredients

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

Other information

Questions or comments?

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

AUSTRALIAN GOLD ULTIMATE HYDRATION 15 CONTINUOUS SPRAY SUNSCREEN

Principal Display Label

AUSTRALIAN GOLD  BROAD SPECTRUM SPF 15
avobenzone, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0145
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE16.44 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE41.1 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE16.44 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
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)  
VINYL ACETATE (UNII: L9MK238N77)  
DIBUTYL MALEATE (UNII: 4X371TMK9K)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
TEA TREE OIL (UNII: VIF565UC2G)  
Product Characteristics
Coloryellow (Colorless to very light Yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0145-4140 mL in 1 CAN; Type 0: Not a Combination Product10/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/31/2019
Labeler - Prime Packaging, Inc. (805987059)
Registrant - Prime Packaging, Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028manufacture(13630-0145) , analysis(13630-0145)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging, Inc.805987059label(13630-0145) , pack(13630-0145)

Revised: 1/2021
Document Id: b8a3d06d-c9cb-2110-e053-2995a90a0238
Set id: 91e601f8-fb9c-470a-e053-2995a90ac964
Version: 2
Effective Time: 20210111
 
Prime Packaging, Inc.