AUSTRALIAN GOLD SPF 30 WITH INSECT REPELLENT- octinoxate, octisalate, octocrylene, oxybenzone spray 
Prime Packaging, 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 SPF 30 Bug Repellent C/S

Active Ingredients

Octinoxate 7.5%

Octisalate 5%

Octocrylene 5%

oxybenzone 4%

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 130°F.

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early sking aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging

Directions

Inactive ingredients

Acrylates/Octylacrylamide Copolymer, Aloe Barbadensis Leaf Extract, Ethyl Butylacetylaminopropionate, Fragrance, Glycine Soja (Soybean) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, SD Alcohol 40-B, Tocopheryl Acetate

Other information

Questions or comments?

Call toll free 1-885-548-4653

AUSTRALIAN GOLD SPF 30 CONTINUOUS SPRAY SUNSCREEN with Insect Repellent

Principal Display Label

AUSTRALIAN GOLD  SPF 30 WITH INSECT REPELLENT
octinoxate, octisalate, octocrylene, oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0162
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SOYBEAN OIL (UNII: 241ATL177A)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALCOHOL (UNII: 3K9958V90M)  
TEA TREE OIL (UNII: VIF565UC2G)  
ETHYL BUTYLACETYLAMINOPROPIONATE (UNII: 65GQA237EH)  
OCTOXYNOL-7 (UNII: 8419DEW37J)  
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
Product Characteristics
Coloryellow (Colorless to very light Yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0162-4159 g in 1 CAN; Type 0: Not a Combination Product09/03/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/03/2019
Labeler - Prime Packaging, Inc. (805987059)
Registrant - Prime Packaging, Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028manufacture(13630-0162) , analysis(13630-0162)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging, Inc.805987059label(13630-0162) , pack(13630-0162)

Revised: 9/2020
Document Id: b00129f7-945f-1047-e053-2995a90a65e5
Set id: b00122a7-2106-7a42-e053-2a95a90a6ee8
Version: 1
Effective Time: 20200923
 
Prime Packaging, Inc.