SOLEIL TOUJOURS PERPETUAL RADIANCE BROAD SPECTRUM SPF 20- titanium dioxide and zinc oxide 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.

----------

Active ingredients

Titanium Dioxide 1.8 % and Zinc Oxide 4.2 %

Purpose

Sunscreen

Uses

Inactive Ingredients

Acrylates Copolymer, Algin, Aloe Barbadensis Leaf Juice, Alumina, Aluminum Hydroxide, Argania Spinosa Kernel Oil, Ascorbyl Palmitate, Beeswax, Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Caramel, Ceramide 2, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Glycerin, Glyceryl Behenate/Eicosadioate, Glyceryl Caprylate, Glyceryl Undecylenate, Guanylcystamine HBr, Hexyl Laurate, Hydrated Silica, Hydrogen Dimethicone, Iron Oxides, Isododecane, Isopropyl Myristate, Laureth-7, Mica, Palmitoyl Hexapeptide-12, PEG-10 Phytosterol, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Porphyra Umbilicalis Extract, Propylene Carbonate, Punica Granatum Extract, Silica, Sodium Chloride, Sodium Hyaluronate, Sodium Metabisulfite, Squalane, Stearalkonium Hectorite, Stearic Acid, Superoxide Dismutase, Tetrahexyldecyl Ascorbate, Titanium Dioxide, Tocopheryl Acetate, Tribehenin, Vitis Vinifera (Grape) Seed Extract, Vitis Vinifera (Grape) Seed Oil, Water  

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


Other information

Questions or comments

Call toll free 1-877-320-2381

PRINCIPAL DISPLAY PANEL - 18mL  Tube with Applicator

PRINCIPAL DISPLAY PANEL - 18 mL Tube with Applicator

SOLEIL

Toujours®

with

Dr. Noëlle Sherber

PERPETUAL

RADIANCE™

BROAD SPECTRUM

SPF 20

COMPLEXION

PERFECTING FLUID

UNIVERSAL TINT

MINERAL BASED

SUNSCREEN

WATER RESISTANT

(80 MINUTES)

18 mL e 0.6 FL OZ

SOLEIL TOUJOURS  PERPETUAL RADIANCE BROAD SPECTRUM SPF 20
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0185
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE17.6 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION41.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARGAN OIL (UNII: 4V59G5UW9X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LEVOMENOL (UNII: 24WE03BX2T)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
CERAMIDE 2 (UNII: C04977SRJ5)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
CARAMEL (UNII: T9D99G2B1R)  
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
GLYCERYL MONOUNDECYLENATE (UNII: IK8A76Q5G8)  
GUANYLCYSTAMINE HYDROBROMIDE (UNII: PF69H864I0)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ISODODECANE (UNII: A8289P68Y2)  
LAURETH-7 (UNII: Z95S6G8201)  
MICA (UNII: V8A1AW0880)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
SQUALANE (UNII: GW89575KF9)  
ORGOTEIN (UNII: PKE82W49V1)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0185-218 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product07/16/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/16/2015
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028label(58443-0185) , pack(58443-0185) , manufacture(58443-0185) , analysis(58443-0185)

Revised: 1/2020
Document Id: 9c5a684e-99d4-676b-e053-2a95a90ac9ba
Set id: cb176843-01b4-4220-946a-02af085c6e9a
Version: 3
Effective Time: 20200117
 
Prime Enterprises, Inc.