AUSTRALIAN GOLD INSTANT BRONZER 15 SUNSCREEN- avobenzone, 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 Instant Bronzer 15 Lotion Sunscreen

Active Ingredients

Avobenzone 2%

Octisalate 5%

Octocrylene 2%

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 with broad 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, & sunglasses.
  • Children under 6 months: Ask a doctor

Inactive Ingredients

Water/Aqua/Eau, Aloe Barbadensis Leaf Juice, Glycerin, Butylphthalimide, Caramel, Polyethylene, Isopropylphthalimide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Sodium Hydroxide, Carbomer, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Olea Europaea (Olive) Fruit Oil, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Tetrasodium Glutamate Diacetate, Allantoin, Camellia Oleifera (Green Tea) Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Fragrance(Parfum), Phenoxyethanol, Ethylhexylglycerin

Other information

  • Protect this product from excessive heat and direct sun
  • May stain some fabrics or surfaces

Questions or comments?

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

Australian Gold Instant Bronzer 15 Lotion Sunscreen

Principal Display Label

AUSTRALIAN GOLD  INSTANT BRONZER 15 SUNSCREEN
avobenzone, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0280
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20.36 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50.9 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20.36 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
ALLANTOIN (UNII: 344S277G0Z)  
TEA TREE OIL (UNII: VIF565UC2G)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
CARAMEL (UNII: T9D99G2B1R)  
CARBOMER 980 (UNII: 4Q93RCW27E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
WATER (UNII: 059QF0KO0R)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCOA BUTTER (UNII: 512OYT1CRR)  
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
Product Characteristics
Colorbrown (Caramel) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0280-4237 mL in 1 TUBE; 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 Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0280) , manufacture(58443-0280) , label(58443-0280) , analysis(58443-0280)

Revised: 10/2019
Document Id: 91ad1822-de1e-fbb4-e053-2995a90a4eae
Set id: 91ad1822-de1d-fbb4-e053-2995a90a4eae
Version: 1
Effective Time: 20191031
 
Prime Enterprises Inc.