AUSTRALIAN GOLD INSTANT BRONZER BROAD SPECTRUM SPF 4 SUNSCREEN- avobenzone, and octocrylene spray 
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 Broad Spectrum SPF 4 Sunscreen

INACTIVE INGREDIENTS

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Caramel, Dimethicone, Ethylhexylglycerin, Fragrance, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Sorbitan Oleate, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tetrasodium Glutamate Diacetate, Tocopheryl Acetate, Trimethylsiloxysilicate, Water​

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cnacer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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. Keep away from face to avoid breathing it.

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.

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.

Purpose

Sunscreen

Uses

Active Ingredients

Avobenzone 1%

Octocrylene 1%

Directions

Other Information

Questions or Comments?

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

Australian Gold INSTANT BRONZER SPF 4 BROAD SPECTRUM Sunscreen

Australian Gold INSTANT BRONZER BROAD SPECTRUM SPF 4 SUNSCREEN

AUSTRALIAN GOLD  INSTANT BRONZER BROAD SPECTRUM SPF 4 SUNSCREEN
avobenzone, and octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0278
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SUNFLOWER SEED (UNII: R9N3379M4Z)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
MELALEUCA ALTERNIFOLIA FLOWERING TOP (UNII: 5AZ4S6N66F)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
CARAMEL (UNII: T9D99G2B1R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
Product Characteristics
Colorbrown (Caramel color) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0278-4237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/16/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/16/2019
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0278) , manufacture(58443-0278) , label(58443-0278) , analysis(58443-0278)

Revised: 4/2020
Document Id: a446bdf8-0cbc-5c9b-e053-2995a90a7fe7
Set id: a446bbb6-2c88-5ca7-e053-2995a90a4532
Version: 1
Effective Time: 20200424
 
Prime Enterprises Inc.