Soleil Toujours
FDA Label NDC 58443-0185

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prime Enterprises, Inc. for the product Soleil Toujours (NDC 58443-0185). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding principal display panel - 18ml  tube with applicator, active ingredients, purpose, uses, inactive ingredients, warnings, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Principal Display Panel - 18Ml  Tube With Applicator

Principal Display Panel (18 mL 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

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

Otc - When Using

When using this product

keep out of eyes.

Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor

if rash occurs.

Otc - Keep Out Of Reach Of Children

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.

* Please review the disclaimer below.