AUSTRALIAN GOLD BOTANICAL SUNSCREEN BROAD SPECTRUM SPF 30 NATURAL- avobenzone, homosalate, octisalate, octocrylene 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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Botanical Sunscreen Broad Spectrum SPF 30 Natural

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.75%

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

Flammable:Avoid fire, flame, heat and smoking. Contents under presssure.Do not puncture or incinerate. Store at temperatures below 120ºC (48ºC).

Directions

Inactive Ingredients

Eucalyptus Globulus Leaf Extract, Fragrance, Glycerin, Porphyra Umbilicalis Extract, SD Alcohol 40-B, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water, Polyester-8

Other Information

Question or comments?

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

Botanical Sunscreen Broad Spectrum SPF 30 Natural

Principle Display Label

AUSTRALIAN GOLD  BOTANICAL SUNSCREEN BROAD SPECTRUM SPF 30 NATURAL
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0274
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25.5 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE85 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE42.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE23.38 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
ALCOHOL (UNII: 3K9958V90M)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Coloryellow (Light Yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0274-4177 mL in 1 CAN; Type 0: Not a Combination Product03/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02003/01/2023
Labeler - Prime Packaging Inc. (805987059)
Registrant - Prime Packaging Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc101946028manufacture(13630-0274) , analysis(13630-0274)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging Inc.805987059pack(13630-0274) , label(13630-0274)

Revised: 7/2023
Document Id: 0074787a-c9bd-ae87-e063-6394a90a2b86
Set id: 0074630f-9d90-9209-e063-6294a90a4f01
Version: 1
Effective Time: 20230714
 
Prime Packaging Inc.