AUSTRALIAN GOLD BROAD SPECTRUM SPF 4- avobenzone, octocrylene, and oxybenzone oil 
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 0.5 %, Octocrylene 1 %, and Oxybenzone 0.5 %

Purpose

Sunscreen

Uses

  • helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cnacer and early skin aging. This product has been shown only to 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 out of eyes. Rinse with water to remove. Keep away from face to avoid breathing it.

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

  • apply liberally 15 minutes before sun exposure
  • 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 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

BHT, Cetyl Acetate, Acetylated Lanolin Alcohol, Daucus Carota Sativa (Carrot) Seed Oil, Dietylhexyl Syringylidene-malonate, Caprylic/Capric Triglyceride, Fragrance (Parfum), Glycine Soja (Soybeen) Oil, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Linolate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mineral Oil, Cocos Nucifera (Coconut) Oil, Aloe Barbadensis Extract, Olea Europaea (Olive) Fruit Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, VP/Hexadecene Copolymer

Other information

  • protect this product from excesive heat and direct sun
  • avoid spraying on fabrics - could cause discolorations

Questions or Comments?

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

PRINCIPAL DISPLAY PANEL - 237 mL  Bottle Label

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label


EXOTIC BLEND

#1 Fragrance

4

Spray Oil

Sunscreen

Carrot Oil Formula

BROAD SPECTRUM SPF 4

WATER RESISTANT

(80 MINUTES)

Australian

Gold

237 mL / 8 Fl. Oz

AUSTRALIAN GOLD  BROAD SPECTRUM SPF 4
avobenzone, octocrylene, and oxybenzone oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0021
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE4.46 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8.92 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4.46 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)  
TRICAPRIN (UNII: O1PB8EU98M)  
SOY ACID (UNII: HBA528N3PW)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ISOPROPYL LINOLEATE (UNII: 4MW1E9AT4H)  
TEA TREE OIL (UNII: VIF565UC2G)  
MINERAL OIL (UNII: T5L8T28FGP)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BLACK OLIVE (UNII: 2M6QWV94OC)  
COCOA BUTTER (UNII: 512OYT1CRR)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0021-4237 mL in 1 BOTTLE; Type 0: Not a Combination Product11/13/201206/24/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/13/201206/24/2021
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028label(58443-0021) , pack(58443-0021) , manufacture(58443-0021) , analysis(58443-0021)

Revised: 5/2022
Document Id: ded13ebe-460d-31b0-e053-2a95a90a04ee
Set id: c1d6cb4c-7289-4cad-9a02-345959f156ab
Version: 4
Effective Time: 20220512
 
Prime Enterprises, Inc.