AUSTRALIAN GOLD INSTANT BRONZER SPF 15 SUNSCREEN- avobenzone, octisalate, 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 15 Spray Gel 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 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 the 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 • 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 a 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-sleeve shirts, pants, hats, and sunglasses • children under 6 months: Ask a doctor

Inactive ingredients

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

PRINCIPAL DISPLAY LABEL

AUSTRALIAN GOLD  INSTANT BRONZER SPF 15 SUNSCREEN
avobenzone, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0277
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE19.8 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE49.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE19.8 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
WATER (UNII: 059QF0KO0R)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
TEA TREE OIL (UNII: VIF565UC2G)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CARAMEL (UNII: T9D99G2B1R)  
Product Characteristics
Colorbrown (Caramel) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0277-4237 mL in 1 BOTTLE; 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(58443-0277) , manufacture(58443-0277) , label(58443-0277) , analysis(58443-0277)

Revised: 1/2021
Document Id: b8b8f229-cf45-c769-e053-2a95a90a2e88
Set id: 91a9a86b-79f7-dd8c-e053-2995a90a2c64
Version: 2
Effective Time: 20210112
 
Prime Enterprises Inc.