AUSTRALIAN GOLD CARROT OIL FORMULA BROAD SPECTRUM SPF 4- avobenzone, octocrylene, oxybenzone 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.

----------

Active ingredients

Avobenzone 1%, Octocrylene 0.85%, and Oxybenzone 0.5%

Purpose

Sunscreen

Uses

  • helps prevent sunburn

Skin Cancer/Skin Aging Alert:

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help 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 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
  • children under 6 months: Ask a doctor.

Inactive Ingrediets:

Acetylated Lanolin Alcohol, Aloe Barbadensis Leaf Extract, BHT, Caprylic/Capric Triglyceride, Cetyl Acetate, Daucus Carota Sativa (Carrot) Seed Oil, Diethylhexyl Syringylidenemalonate, Fragrance (Parfum), Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Lanolate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Terminalia Ferdinandiana (Kakadu Plum) Seed Oil Extract, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, VP/Hexadecene Copolymer



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 Spray Oil Sunscreen Broad Spectrum SPF 4

Principal Display LabelPrincipal Display Label

AUSTRALIAN GOLD  CARROT OIL FORMULA BROAD SPECTRUM SPF 4
avobenzone, octocrylene, oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0167
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE9 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.65 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CETYL ACETATE (UNII: 4Q43814HXS)  
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)  
CARROT SEED OIL (UNII: 595AO13F11)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SOYBEAN OIL (UNII: 241ATL177A)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
LANOLIN (UNII: 7EV65EAW6H)  
TEA TREE OIL (UNII: VIF565UC2G)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
COCOA BUTTER (UNII: 512OYT1CRR)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0167-4237 mL in 1 BOTTLE; Type 0: Not a Combination Product03/05/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/05/2014
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028label(58443-0167) , pack(58443-0167) , manufacture(58443-0167) , analysis(58443-0167)

Revised: 2/2022
Document Id: d91907ae-198e-37ab-e053-2995a90a2ec2
Set id: 7c74209d-cd4d-45fa-8d04-fab21b29af28
Version: 4
Effective Time: 20220228
 
Prime Enterprises, Inc.