AUSTRALIAN GOLD BROAD SPECTRUM SPF 4- avobenzone, octocrylene oil 
Prime Enterprises, Inc.

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Australian Gold Spray Oil Sunscreen Broad Spectrum SPF 4

Active ingredients

Avobenzone 1 %, Octocrylene 1 %

Purpose

Sunscreen

Uses

Warnings

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

Inactive Ingredients

Acetylated Lanolin Alcohol, Aleurites Moluccana Seed Oil, Aloe Barbadensis Leaf Extract, BHT, Caprylic/Capric Triglyceride, Cetyl Acetate, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Seed Oil, Diethylhexyl Syringylidene-Malonate, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Lanolate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Terminalia Ferdinandiana (Kakadu Plum) Seed Oil, Tocopheryl Acetate, VP/Hexadecene Copolymer

Other information

Questions or Comments?

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

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

Principle Display LabelPrinciple Display Label

AUSTRALIAN GOLD  BROAD SPECTRUM SPF 4
avobenzone, octocrylene oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0457
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE9.02 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9.02 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
OLIVE OIL (UNII: 6UYK2W1W1E)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
CARROT SEED OIL (UNII: 595AO13F11)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CETYL ACETATE (UNII: 4Q43814HXS)  
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ISOPROPYL LINOLEATE (UNII: 4MW1E9AT4H)  
TEA TREE OIL (UNII: VIF565UC2G)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU)  
TRICAPRIN (UNII: O1PB8EU98M)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0457-4237 mL in 1 BOTTLE; Type 0: Not a Combination Product12/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/22/2020
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028label(58443-0457) , pack(58443-0457) , manufacture(58443-0457) , analysis(58443-0457)

Revised: 5/2024
Document Id: 178ec3da-ec24-8948-e063-6294a90aefcd
Set id: d21b7132-13fc-7991-e053-2a95a90a814a
Version: 3
Effective Time: 20240503
 
Prime Enterprises, Inc.