AUSTRALIAN GOLD BOTANICAL BROAD SPECTRUM SPF 70- 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 70 Natural Spray

Active Ingredients

Avobenzone 3%

Homosalate 10%

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

Eucalyptus Globulus (Eucalyptus) Leaf Extract, Fragrance (Parfum), Glycerin, Polyester-8, Porphyra Umbilicalis Extract, SD Alcohol 40-B, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopheryl Acetate, Trimethoxybenzylidene Pentanedione, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water/Aqua/Eau

Other information

Questions or comments?

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

Botanical Sunscreen 70 Broad Spectrum SPF 70 Natural Spray

Principal Display Label

AUSTRALIAN GOLD BOTANICAL  BROAD SPECTRUM SPF 70
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0140
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE86.1 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25.83 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE43.05 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE43.05 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIMETHOXYBENZYLIDENE PENTANEDIONE (UNII: 322V0ACF25)  
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALCOHOL (UNII: 3K9958V90M)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
VINYL ACETATE (UNII: L9MK238N77)  
DIBUTYL MALEATE (UNII: 4X371TMK9K)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0140-4177 mL in 1 CAN; Type 0: Not a Combination Product10/02/201802/28/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02010/02/201802/28/2025
Labeler - Prime Packaging, Inc. (805987059)
Registrant - Prime Packaging, Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028manufacture(13630-0140) , analysis(13630-0140)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging, Inc.805987059label(13630-0140) , pack(13630-0140)

Revised: 6/2022
Document Id: e1f6d8d1-9181-16bc-e053-2a95a90a0cfb
Set id: 8cb6360e-d02b-a48f-e053-2a95a90aed2f
Version: 3
Effective Time: 20220621
 
Prime Packaging, Inc.