FDA.reportPublic FDA data

Soleil Toujours

Manufacturer
Prime Enterprises Inc.
Effective date
2022-08-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:50:28

Label at a glance#

ProductSoleil Toujours Broad Spectrum SPF 30 Sunscreen
Active ingredientOCTISALATE, AVOBENZONE, HOMOSALATE
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 breathe mist in. Allow to fully dry. 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 agin...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 7.5%

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 us e on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if rash occurs. Keep away from face to avoid breathing it, Contents under pressure - do not puncture or incinerate. 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: Do not use near heat,flame or while smoking.

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 breathe mist in. Allow to fully dry.
  • 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 broad spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

Abies siberica Needle Oil, Aloe Barbadensis Leaf Juice, 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, Cucumis Sativus (Cucumber) Extract, 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, Sodium Hyaluronate, Tetrahexyldecyl Ascorbate, Thymus vulgaris Oil, Tocopheryl Acetate, Triethyl Citrate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Vanillin, Water

Other Information

OTHER SAFETY INFORMATION

  • Protect the product in this container from excessive heat and direct sunlight.

Question or comments?

OTC - QUESTIONS SECTION

Call 1-877-320-2381

Soleil Toujours Set + Protect Micro Mist Broad Spectrum SPF 30 SPF 30 Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display LabelPrinciple Display Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0555-32024-01-30C16284748780-11030e365-6dbb-111a-e063-dadaa90a10e2Soleil Toujors Set + Protect Micro Mist Broad Spectrum SPF 30 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0555-3Soleil ToujoursBroad Spectrum SPF 30 Sunscreen59 mL in 1 TUBELOTION591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0555SOLEIL TOUJOURS BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE) LOTION [PRIME ENTERPRISES INC.]1Legacy NDC, 1 package rows20220818_e6629504-b211-4cd1-e053-2a95a90a2826.zip

Products#

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

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-055558443-0555-3

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
BERGAMOT OIL39W1PKE3JIIACT
ORANGE PEELTI9T76XD44IACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
WATER059QF0KO0RIACT
LEMON OIL, COLD PRESSEDI9GRO824LLIACT
CITRUS NOBILIS8MFF77J91VIACT
LEVOMENOL24WE03BX2TIACT
CITRUS AURANTIIFOLIA FRUIT OIL7937R189CBIACT
CITRUS MAXIMA FRUIT RIND OIL8U3877WD44IACT
CITRUS RETICULATA LEAF OIL1515UE78IHIACT
SPEARMINT OILC3M81465G5IACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
SANTALUM SPICATUM OILH9LVS6REV4IACT
ALCOHOL3K9958V90MIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
VANILLINCHI530446XIACT
MENTHA PIPERITA LEAFA389O33LX6IACT
POGOSTEMON CABLIN LEAF OILF3IN55X5POIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
THYME OIL2UK410MY6BIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GALBANUM OIL211UF7M8N1IACT
JUNIPERUS VIRGINIANA OILPAD4FN7P2GIACT
LAVENDER OILZBP1YXW0H8IACT
MYRRH OILH74221J5J4IACT
CUCUMBERYY7C30VXJTIACT
EUCALYPTUS OIL2R04ONI662IACT
ROSA DAMASCENA FLOWER OIL18920M3T13IACT
CLARY SAGE OIL87L0D4U3M0IACT
PELARGONIUM GRAVEOLENS FLOWER OIL3K0J1S7QGCIACT
ABIES SIBIRICA WHOLE80YP21OD21IACT
ETHYL VANILLINYC9ST449YJIACT
NUTMEG OILZ1CLM48948IACT
PORPHYRA UMBILICALIS14AN0J70WOIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ASCORBYL PALMITATEQN83US2B0NIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
OCTISALATE4X49Y0596WACTIB

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
e6627a59-c59a-c1c9-e053-2a95a90ae506e6629504-b211-4cd1-e053-2a95a90a28262022-08-16WarningsExact identifier
spl id: e6627a59-c59a-c1c9-e053-2a95a90ae506
spl set id: e6629504-b211-4cd1-e053-2a95a90a2826

Reported adverse events (FAERS/openFDA)#

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