AUSTRALIAN GOLD MERMAID SPF 50 GLITTER SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, and 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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Mermaid SPF 50 Justice Glitter Sunscreen

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.75%

Oxybenzone 4%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

  • keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

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: Do not use near heat, flame or while smoking.

Directions

Aloe Barbadensis Leaf Juice, Butane, Cholecalciferol, Fragrance, Mica, Propane, SD Alcohol 40-B, Titanium Dioxide, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other Information

Question or comments?

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

Mermaid SPF 50 Glitter Sunscreen

Principal Display Image

AUSTRALIAN GOLD  MERMAID SPF 50 GLITTER SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE26.04 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE86.8 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE43.4 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE23.87 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE34.72 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BUTANE (UNII: 6LV4FOR43R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPANE (UNII: T75W9911L6)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALCOHOL (UNII: 3K9958V90M)  
DIBUTYL MALEATE (UNII: 4X371TMK9K)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0102-4177 mL in 1 CAN; Type 0: Not a Combination Product02/29/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/29/2016
Labeler - Prime Packaging Inc. (805987059)
Registrant - Prime Packaging Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc101946028manufacture(13630-0102) , analysis(13630-0102)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging Inc.805987059pack(13630-0102) , label(13630-0102)

Revised: 1/2020
Document Id: 9c5c3921-6c83-7b53-e053-2995a90aa31e
Set id: 2af9fdbf-1d63-675d-e054-00144ff8d46c
Version: 2
Effective Time: 20200117
 
Prime Packaging Inc.