AUSTRALIAN GOLD SPF 15- 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 Spray Gel Sunscreen SPF 15

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 form 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, Aloe Barbadensis leaf Juice, Glycerin, Butylphthallmide, Caramel, Phenoxyethanol, Isopropylphthalimide, Fragrance, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, polysorbate 20, Trimethylsiloxysilicate, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Tocopheryl Acetate, Tetrasodium Glutamte Diacetate, Hydroxypropyl Methylcellulose, Ethylhexylglycerin, Sodium Hydroxide, propylene Glycol, Sorbitan Oleate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Chloride

Other information

Questions or comments?

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

Australian Gold Instant Bronzer Spray Gel Sunscreen SPF15

Principle Display LabelPrinciple Display Label

AUSTRALIAN GOLD  SPF 15
avobenzone, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0588
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE19.4 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE48.5 g  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE19.4 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
TEA TREE OIL (UNII: VIF565UC2G)  
CARAMEL (UNII: T9D99G2B1R)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Product Characteristics
Colorbrown (Caramel) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0588-3100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02001/22/2021
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028manufacture(58443-0588) , label(58443-0588) , analysis(58443-0588) , pack(58443-0588)

Revised: 11/2022
Document Id: ed9d3eb0-320a-212f-e053-2a95a90a4df4
Set id: ed9d526b-aeeb-6385-e053-2a95a90a9731
Version: 1
Effective Time: 20221116
 
Prime Enterprises, Inc.