AUSTRALIAN GOLD MERMAID SPF 50 GLITTER SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion 
Prime Enterprises 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 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.

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.

Directions

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates Copolymer, Allantoin, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Disodium EDTA, Ethylene/VA Copolymer, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylisothiazolinone, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polybutylene Terephthalate, Polyethylene, Polysilicone-15, Polysorbate 20, Propylene Glycol, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water

Other Information

Questions 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 lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0222
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE41.04 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30.78 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE102.6 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE51.3 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE28.22 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ETHYLENE-VINYL ACETATE COPOLYMER (50% VINYL ACETATE) (UNII: 3H390O24SI)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
TEA TREE OIL (UNII: VIF565UC2G)  
COCOA BUTTER (UNII: 512OYT1CRR)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
DIMETHYL TEREPHTHALATE (UNII: IKZ2470UNV)  
ALLANTOIN (UNII: 344S277G0Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSILICONE-15 (UNII: F8DRP5BB29)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0222-4237 mL in 1 BOTTLE; Type 0: Not a Combination Product02/08/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/08/2016
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028analysis(58443-0222) , pack(58443-0222) , manufacture(58443-0222) , label(58443-0222)

Revised: 1/2020
Document Id: 9c591e3e-8c56-b0c4-e053-2995a90aea13
Set id: 2b453a8d-cdfb-53ea-e054-00144ff88e88
Version: 2
Effective Time: 20200117
 
Prime Enterprises Inc.