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

Soleil Toujours by

Drug Labeling and Warnings

Soleil Toujours by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Titanium Dioxide 1.8 % and Zinc Oxide 4.2 %

Purpose

Sunscreen

Uses

• helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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

• SHAKE WELL.
• Apply liberally 15 minutes before sun exposure
• Reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10 a.m. - 2 p.m.
• Wear long-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a doctor.

Other information

• Protect this product from excessive heat and direct sun.

Questions or comments

Call toll free 1-877-320-2381

PRINCIPAL DISPLAY PANEL - 18mL  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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0185
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	17.6 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	41.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0185-2	18 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	07/16/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/16/2015

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	label(58443-0185) , pack(58443-0185) , manufacture(58443-0185) , analysis(58443-0185)