AUSTRALIAN GOLD SPF 30 SPORT ULTRA CHILL- octisalate, avobenzone, homosalate, 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 SPF 30 Sport Ultra Chill Spray Gel

Purpose

Sunscreen

Active Ingredients

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocrylene 5%

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 useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif 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 holds 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 value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10am-2pm
  • wear long sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

INACTIVE INGREDIENTS

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

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 SPF 30 Lotion Sport Ultra Chill Spray Gel

Principal Display FrontPrincipal Display Back

AUSTRALIAN GOLD  SPF 30 SPORT ULTRA CHILL
octisalate, avobenzone, homosalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0634
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE72.75 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE48.5 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE29.1 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE48.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL (UNII: L7T10EIP3A)  
TEA TREE OIL (UNII: VIF565UC2G)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0634-4237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/04/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02008/04/2023
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0634) , manufacture(58443-0634) , label(58443-0634) , analysis(58443-0634)

Revised: 8/2023
Document Id: 021b08c8-a0f6-fb35-e063-6394a90acf97
Set id: 021b0c34-68c5-1735-e063-6294a90a3aaa
Version: 1
Effective Time: 20230804
 
Prime Enterprises Inc.