AUSTALIAN GOLD BROAD SPECTRUM SPF 30 SUNSCREEN- octisalate, avobenzone, octocrylene, homosalate 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 Broad Spectrum SPF 30

Active Ingredients

Avobenzone 3.0%

Homosalate 7.5%

Octisalate 5.0%

Octocrylene 5.0%

Purpose

Sunscreen

Uses

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

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Glycerin, Phenoxyethanol, Caramel, Phenoxyethanol, 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 Glutamate 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 Broad Spectrum SPF 30

Principle Display LabelPrinciple Display Label

AUSTALIAN GOLD  BROAD SPECTRUM SPF 30 SUNSCREEN
octisalate, avobenzone, octocrylene, homosalate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0612
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE48 g  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE28.8 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE48 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE75.15 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
GLYCERIN (UNII: PDC6A3C0OX)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARAMEL (UNII: T9D99G2B1R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
TEA TREE OIL (UNII: VIF565UC2G)  
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:58443-0612-4237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02010/30/2019
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028manufacture(58443-0612) , pack(58443-0612) , label(58443-0612) , analysis(58443-0612)

Revised: 3/2023
Document Id: f605b408-6cf2-2d55-e053-2a95a90a3364
Set id: f605b389-8f2a-307c-e053-2995a90aa7d4
Version: 1
Effective Time: 20230303
 
Prime Enterprises Inc.