SUNSHINE AND GLITTER BROAD SPECTRUM SPF 50 GLAMINGO GLITTER SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene 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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Sunshine & Glitter Sea Star Sparkle Mermaid Glitter Sunscreen Lotion Broad Spectrum SPF 50

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 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

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Ethylhexylglycerin, Fragrance, Glycerin, Hydroxypropyl Methylcellulose, Microcrystalline Cellulose, Phenoxyethanol, Polybutylene Terephthalate, Polyethylene , Polylactic Acid, Polysorbate 20, Polyurethane, Polyurethane-33, Propylene Glycol, Sodium Hydroxide, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water

Questions or comments?

Call 1-888-601-0441

Sunshine & Glitter Sea Star Sparkle Mermaid Glitter Sunscreen Lotion Broad Spectrum SPF 50

Principle Display Label

SUNSHINE AND GLITTER  BROAD SPECTRUM SPF 50 GLAMINGO GLITTER SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0520
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE99 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYLACTIDE (UNII: 459TN2L5F5)  
POLYURETHANE-62 (UNII: TBK645J3J8)  
POLYURETHANE-34 (55 MPA, TENSILE STRENGTH OF FILM AT BREAK) (UNII: II1242QJ7P)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
COCOA BUTTER (UNII: 512OYT1CRR)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
Product Characteristics
Colorgreen (Slightly Greenish Blue) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0520-3100 mL in 1 TUBE; Type 0: Not a Combination Product12/08/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/08/2021
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0520) , manufacture(58443-0520) , label(58443-0520) , analysis(58443-0520)

Revised: 1/2022
Document Id: d5ce3881-40b0-22e8-e053-2a95a90a982f
Set id: d5ce4996-14a7-560d-e053-2a95a90a795a
Version: 1
Effective Time: 20220117
 
Prime Enterprises Inc.