CONCEPT II SOLSCENTS BROAD SPECTRUM SPF 15 PINA COLADA- avobenzone, octisalate, and 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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Concept II SolScents Broad Spectrum SPF 15 Pina Colada

Active Ingredients

Avobenzone 2%

Octisalate 5% Octocrylene 1.85%

Purpose

Sunscreen

Uses

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, Allantoin, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Fragrance (Parfum), Hydroxypropyl Methylcellulose, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Polyethylene, Polysorbate 20, Propylene Glycol, Propylparaben, Sorbitan Oleate, Sorbitol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water (Aqua).

Other Information

Questions or comments?

SolScents, LLC. 2200 N.W. 92nd Avenue. Miami, Florida 33172

Concept II SolScents Broad Spectrum SPF 15 Pina Colada

Principal Display Image

CONCEPT II  SOLSCENTS BROAD SPECTRUM SPF 15 PINA COLADA
avobenzone, octisalate, and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0215
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE18.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
COCOA BUTTER (UNII: 512OYT1CRR)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SORBITOL (UNII: 506T60A25R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALLANTOIN (UNII: 344S277G0Z)  
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0215-4236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/20/2013
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0215) , manufacture(58443-0215) , label(58443-0215)

Revised: 1/2020
Document Id: 9c5970fb-9bc2-6e87-e053-2a95a90a6889
Set id: 280bb216-309f-4db9-e054-00144ff8d46c
Version: 2
Effective Time: 20200117
 
Prime Enterprises Inc.