AUSTRALIAN GOLD LITTLE JOEY 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 little joey SPF 50 kids

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

Directions

Inactive ingredients

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

Other information

Questions or comments?

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

Australian Gold Little Joey SPF 50

Principal display Label

AUSTRALIAN GOLD  LITTLE JOEY SPF 50
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0170
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TEA TREE OIL (UNII: VIF565UC2G)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALCOHOL (UNII: 3K9958V90M)  
VINYL ACETATE (UNII: L9MK238N77)  
DIBUTYL MALEATE (UNII: 4X371TMK9K)  
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)  
WATER (UNII: 059QF0KO0R)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
Product Characteristics
Coloryellow (light yellow to yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0170-4170 g 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 finalpart35211/18/2019
Labeler - Prime Packaging, Inc. (805987059)
Registrant - Prime Packaging, Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028manufacture(13630-0170) , analysis(13630-0170)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging, Inc.805987059label(13630-0170) , pack(13630-0170)

Revised: 9/2020
Document Id: b079f185-31ca-2991-e053-2a95a90a18eb
Set id: b079f5ea-b052-d648-e053-2a95a90a7c7f
Version: 1
Effective Time: 20200929
 
Prime Packaging, Inc.