AUSTRALIAN GOLD SPF 15 SHEER COVERAGE SUNSCREEN- avobenzone, octocrylene, and octisalate 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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Ausralian Gold SPF 15 Sheer Coverage Sunscreen

Active Ingredients

Avobenzone 2%

Octisalate 5%

Octocrylene 1.85%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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

  • apply liberally 15 minutes before sun exposure
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun protection measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Disodium EDTA, Fragrance (Parfum), Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Isopropylphthalimide, Methylisothiazolinone, Phenoxyethanol, Phenyl Trimethicone, Polyethylene, Polysilicone-15, Potassium Cetyl Phosphate, Potassium Hydroxide, Propylene Glycol, Silica, Stearyl Alcohol, Styrene/Acrylates Copolymer, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopheryl Acetate, Water (Aqua)

Other Information

  • protect this product from excessive heat and direct sun

Questions or comments?

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

Australian Gold SPF 15 Sheer Coverage Sunscreen

Principal Display Image

AUSTRALIAN GOLD  SPF 15 SHEER COVERAGE SUNSCREEN
avobenzone, octocrylene, and octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0177
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE18.8 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE47 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE17.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
LICORICE (UNII: 61ZBX54883)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
POLYSILICONE-15 (UNII: F8DRP5BB29)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0177-4177 mL in 1 TUBE; Type 0: Not a Combination Product02/28/201402/13/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/28/201402/13/2019
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028manufacture(58443-0177) , pack(58443-0177) , label(58443-0177) , analysis(58443-0177)

Revised: 5/2022
Document Id: ded2845b-bf6a-275f-e053-2a95a90a5a92
Set id: 2b70d706-35b0-29da-e054-00144ff8d46c
Version: 3
Effective Time: 20220512
 
Prime Enterprises Inc.