AUSTALIAN GOLD SPF 6 SUNSCREEN LOW PROTECTION- n/a 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 Spray Oil Suncreen SPF 6 LOW PROTECTION

Active Ingredients

Avobenzone 1%

Octocrylene 0.85%

Oxybenzone 0.5%

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.

Directions

INACTIVE INGREDIENTS

Acetylated Lanolin Alcohol, Aloe Barbadensis Leaf Extract, BHT, Caprylic/Capric Triglyceride, Cetyl Acetate, Daucus Carota Sativa (Carrot) Seed Oil, Diethylhexyl Syringylidenemalonate, Fragrance, 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, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, VP/Hexadecene Copolymer

Other Information

Questions or comments?

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

Australian Gold Spray Oil Sunscreen Hydrating formula SPF 6 LOW PROTECTION

Principle Display LabelPrinciple Display Label

AUSTALIAN GOLD  SPF 6 SUNSCREEN LOW PROTECTION
n/a spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0318
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.65 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4.5 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE9 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TEA TREE OIL (UNII: VIF565UC2G)  
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
LANOLIN ACID (UNII: D1CZ545P7Z)  
SOYBEAN OIL (UNII: 241ATL177A)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETYL ACETATE (UNII: 4Q43814HXS)  
CARROT SEED OIL (UNII: 595AO13F11)  
COCOA BUTTER (UNII: 512OYT1CRR)  
CITRAL (UNII: T7EU0O9VPP)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
COUMARIN (UNII: A4VZ22K1WT)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0318-4237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/30/2017
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0318) , manufacture(58443-0318) , label(58443-0318) , analysis(58443-0318)

Revised: 9/2022
Document Id: e9bada66-834f-fe2d-e053-2a95a90a26ca
Set id: a52a357b-7b7a-543b-e053-2a95a90a75c8
Version: 2
Effective Time: 20220928
 
Prime Enterprises Inc.