AUSTRALIAN GOLD BROAD SPECTRUM 30- avobenzone, homoslate, octisalate ,octocrylene and oxybenzone 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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Active ingredients

Avobenzone 3 %, Homosalate 7.5 %, Octisalate 5 %, Octocrylene 2.75 % and Oxybenzone 2 %

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use on broken or damaged skin

When using this product keep out of eyes. Rinse with water to remove. Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinirate. Do not store at temperatures above 120 0F

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: Do not use near heat, flame or while smoking

Directions

Inactive Ingredients

Artemisia Princeps (Yomogi) Extract, Buddleja Davidii (Butterfly Bush) Extract, C12-15 Alkyl Benzoate, Diethylhexyl 2,6-Naphthalate, Diisopropyl Adipate, Fragrance (Parfum), Octyldodecyl Citrate Crosspolymer, Phenethyl Benzoate, Polyester-8, Propylene Glycol, SD Alcohol 40-B (Alcohol Denat.), Tocopheryl Acetate, Tridecyl Neopentanoate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other information

Questions or Comments?

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

PRINCIPAL DISPLAY PANEL - 150 mL Can Label

PRINCIPAL DISPLAY PANEL - 150 mL Can Label

Australian Gold

HELLO

KITTY

Wet/Dry Skin Formula

Body Mist Sunscreen

Krazy Kiwi

30

BROAD SPECTRUM SPF 30

Water Resistant (80 minutes)

5 FL OZ (150mL)

AUSTRALIAN GOLD  BROAD SPECTRUM 30
avobenzone, homoslate, octisalate ,octocrylene and oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0071
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE26.6 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE66.5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE44.4 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE24.4 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE17.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
PHENETHYL BENZOATE (UNII: 0C143929GK)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)  
DIBUTYL MALEATE (UNII: 4X371TMK9K)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
BUDDLEJA DAVIDII LEAF (UNII: X380815D32)  
TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0071-3150 mL in 1 CAN; Type 0: Not a Combination Product12/19/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/19/2013
Labeler - Prime Packaging, Inc. (805987059)
Registrant - Prime Packaging, Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028manufacture(13630-0071) , analysis(13630-0071)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging, Inc.805987059label(13630-0071) , pack(13630-0071)

Revised: 1/2020
Document Id: 9c5c3921-6c47-7b53-e053-2995a90aa31e
Set id: e37e2d2f-eb6e-4250-9fa0-2923587212b2
Version: 3
Effective Time: 20200117
 
Prime Packaging, Inc.