Soleil Toujours

Manufacturer
Prime Packaging Inc. | Prime Enterprises Inc
Effective date
2021-11-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:45:14

Label at a glance#

ProductSoleil Toujours SPF 50 Sunscreen Mist
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE
Label structure9 sections

Indications and 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

Dosage and administration

Shake well before use with your eyes completely closed, mist face evenly, holding bottle 10-12 inches away from face. Do not breath mist in,Allow to fully dry. apply liberally 15 minutues 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 agin...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove. Keep away from face to avoid breathing it. Contents under pressure- do not puncture or incinerate it. Do not store at temperatures above 120ºF.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

Flammable: Contents under pressure. Do not puncture or incinerate. Do no store at temperatures above 120°F. Do not use in the presence of a flame or spark, or while smoking.

INACTIVE INGREDIENT SECTION

Abies Siberica Needle Oil, Ascorbyl Palmitate, Bisabolol, Camellia Oleifera (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Citrus Aurantifolia Fruit Oil, Citrus Aurantium Bergamia Fruit Extract, Citrus Aurantium Dulcis Peel Oil, Citrus Grandis Peel Oil, Citrus Limon Peel Oil, Citrus Nobilis Peel Oil, Citrus Reticulata Leaf Oil, Commiphora Myrrha Resin Oil, Ethyl Vanillin, Eucalyptus Globulus Leaf Oil, Ferula Galbaniflua Oil, Glycerin, Juniperus virginiana Oil, Lavandula Angustifolia Oil, Mentha Piperita Stem/Leaf Oil, Mentha Viridis Leaf Oil, Myristica Fragrans Kernel Oil, Pelargonium Graveolens Flower Oil, Pogostemon Cablin Oil, Polyester-8, Porphyra Umbilicalis Extract, Rosa Damascena Flower Oil, Salvia Sclarea Oil, Santalum Spicata Wood Oil, SD Alcohol 40-B, Tetrahexyldecyl Ascorbate, Thymus Vulgaris Oil, Tocopheryl Acetate, Triethyl Citrate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Vanillin, Water

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well before use
  • with your eyes completely closed, mist face evenly, holding bottle 10-12 inches away from face. Do not breath mist in,Allow to fully dry.
  • apply liberally 15 minutues 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

SPL UNCLASSIFIED SECTION

  • protect this product from excessive heat and direct sun

Question or comments?

OTC - QUESTIONS SECTION

Call 1-877-320-2381

Soleil Toujours Face and Scalp Sunscreen Mist Broad Spectrum SPF 50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display LabelPrinciple Display Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13630-0200-32023-01-30C16284748780-1f386c64a-0e97-0266-e053-dadaa90a7c1aSoleil Toujours Face and Scalp Sunscreen Mist Broad Spectrum SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13630-0200-3Soleil ToujoursSPF 50 Sunscreen Mist59 mL in 1 CANSPRAY594

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13630-0200SOLEIL TOUJOURS SPF 50 SUNSCREEN MIST (AVOBENZONE, HOMOSALATE, OCTISALATE) SPRAY [PRIME PACKAGING INC.]4Legacy NDC, 1 package rows20211201_d1f40073-0d31-e323-e053-2995a90a6f02.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13630-020013630-0200-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d1f4b565-167d-4943-e053-2a95a90a2cf8d1f40073-0d31-e323-e053-2995a90a6f022021-11-29WarningsExact identifier
spl id: d1f4b565-167d-4943-e053-2a95a90a2cf8
spl set id: d1f40073-0d31-e323-e053-2995a90a6f02

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.