AUSTRALIAN GOLD BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion 
Prime Enterprises, 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 Plant Based Lotion Sunscreen Broad Spectrum SPF 50

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 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.

Directions

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Water, Cocos Nucifera (Coconut) Oil, Glycerin, Tapioca Starch, VP/Acrylates/Lauryl Methacrylate Copolymer, Phenoxyethanol, Acrylic Acid/VP Crosspolymer, Fragrance, Sodium Hydroxide, Caprylyl Glycol, Polyacrylate-13, Ethylhexylglycerin, Tocopheryl Acetate, Tetrasodium Glutamate Diacetate, Polyisobutene, Polymethylsilsesquioxane, Polysorbate 20

Other information

Questions or Comments?

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

PRINCIPAL DISPLAY PANEL

Principle Display Label

AUSTRALIAN GOLD  BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0459
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE29.07 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE96.9 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE48.45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE48.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
N-VINYLPYRROLIDINONE (UNII: 76H9G81541)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
POLYACRYLAMIDE (1300000 MW) (UNII: SC5Y4X78TG)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
COCONUT OIL (UNII: Q9L0O73W7L)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LAURYL METHACRYLATE (UNII: B6L83074BZ)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0459-4177 mL in 1 TUBE; Type 0: Not a Combination Product11/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/23/2020
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028label(58443-0459) , pack(58443-0459) , manufacture(58443-0459) , analysis(58443-0459)

Revised: 12/2021
Document Id: d21c4558-5bad-8b3a-e053-2995a90aaef7
Set id: d21c63e6-1bc4-397e-e053-2a95a90a13b6
Version: 1
Effective Time: 20211201
 
Prime Enterprises, Inc.