AUSTRALIAN GOLD INSTANT BRONZER BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene spray 
Prime Packaging, Inc.

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AUSTRALIAN GOLD INSTANT BRONZER 30 CONTINUOUS SPRAY SUNSCREEN

Active Ingredients

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocrylene 5%

Purpose

Sunscreen

Uses

Warnings

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 swalowed, get medical help or contact a Poison Control Center right away.

Flammable: Avoid fire, flame heat and smoking. Contents under pressure. Do not puncture or incinerate. Store at temperatures below 120°F (50°C).

Directions

Inactive ingredients

SD Alcohol 40-B [Alohol Denat.], Water/Aqua/Eau, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Polyester-8, Helianthus Annuus (Sunflower) Seed Oil, Tocopheryl Acetate, Glycerin, Aloe Barbadensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Fragrance (Parfum), Yellow 5 (CI 19140), Red 40 (CI 16035), Blue 1 (CI 42090)

Other information

Questions or comments?

Call toll free 1-885-LIV-GOLD (548-4653)

AUSTRALIAN GOLD INSTANT BRONZER 30 CONTINUOUS SPRAY SUNSCREEN

Principal Display Label

AUSTRALIAN GOLD  INSTANT BRONZER BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0143
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25.53 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE63.825 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE42.55 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE42.55 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALCOHOL (UNII: 3K9958V90M)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
VINYL ACETATE (UNII: L9MK238N77)  
DIBUTYL MALEATE (UNII: 4X371TMK9K)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
TEA TREE OIL (UNII: VIF565UC2G)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
Colorbrown (Dark Amber) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0143-4145 mL in 1 CAN; Type 0: Not a Combination Product10/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02010/31/2019
Labeler - Prime Packaging, Inc. (805987059)
Registrant - Prime Packaging, Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028manufacture(13630-0143) , analysis(13630-0143)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging, Inc.805987059label(13630-0143) , pack(13630-0143)

Revised: 5/2024
Document Id: 177d4647-6f82-c0b1-e063-6394a90a8a23
Set id: 91d2e1d6-4c9d-9b52-e053-2995a90a2dd4
Version: 4
Effective Time: 20240502
 
Prime Packaging, Inc.