AUSTRALIAN GOLD INSTANT BRONZER BROAD SPECTRUM SPF 6 SUNSCREEN- avobenzone, octocrylene spray 
Prime Enterprises Inc.

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Australian Gold INSTANT BRONZER Broad Spectrum SPF 4 Sunscreen

Active Ingredients

Avobenzone 1%

Octocrylene 1%

Purpose

Sunscreen

Uses

  • helps prevent sunburn

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 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.

Directions

  • shake well before use
  • apply liberally 15 minutes before sun exposure and rub into skin
  • hold container 4 to 6 inches from skin to apply
  • do not spray directly into face. Spray on hands then apply to face
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • children under 6 months: Ask a doctor

INACTIVE INGREDIENTS

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

Other Information

  • Protect this product from excesive 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 SPF 4 BROAD SPECTRUM Sunscreen

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AUSTRALIAN GOLD  INSTANT BRONZER BROAD SPECTRUM SPF 6 SUNSCREEN
avobenzone, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0642
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
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SUNFLOWER SEED (UNII: R9N3379M4Z)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
TEA TREE OIL (UNII: VIF565UC2G)  
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)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
Product Characteristics
Colorbrown (Caramel) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0642-4237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/18/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/18/2022
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0642) , manufacture(58443-0642) , label(58443-0642) , analysis(58443-0642)

Revised: 10/2023
Document Id: 08f319c4-c745-b995-e063-6294a90a5c3d
Set id: 08f2fbb3-2fd0-508c-e063-6394a90a6091
Version: 1
Effective Time: 20231030
 
Prime Enterprises Inc.