FDA.reportPublic FDA data

Soleil Toujours

Manufacturer
Prime Packaging Inc. | Prime Enterprises Inc
Effective date
2022-01-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:13:58

Label at a glance#

ProductSoleil Toujours SPF 50 Sheer Sunscreen
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 Hold container 4 to 6 inches from skin to apply. Apply liberally 15 minutes before sun exposure Do not spray directly into face Reapply: after 80 minutes of swimming and 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 spe...

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.

SPL UNCLASSIFIED SECTION

Flammable: Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120ºF. Do not use in the presence of a flame or spark, or while smoking.

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin.

OTC - WHEN USING SECTION

When using this product: Keep away from face to avoid breathing in • Keep out of eyes. Rinse with water to remove.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if rash occurs.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well
  • Hold container 4 to 6 inches from skin to apply.
  • Apply liberally 15 minutes before sun exposure
  • Do not spray directly into face
  • Reapply:
  • after 80 minutes of swimming and 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. Avoid spraying on fabrics - could cause discoloration.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ascorbyl Palmitate, Bisabolol, Camellia Oleifera (Green Tea) Leaf Extract, Fragrance, Glycerin, Polyester-8, Porphyra Umbilicalis Extract, SD Alcohol 40-B, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water

Soleil Toujours SPF 50 Sheer Sunscren Mist

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display LabelPrinciple Display Label

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13630-020913630-0209-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
PORPHYRA UMBILICALIS14AN0J70WOIACT
ALCOHOL3K9958V90MIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
ASCORBYL PALMITATEQN83US2B0NIACT
GLYCERINPDC6A3C0OXIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
LEVOMENOL24WE03BX2TIACT
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
d5df10bc-16ff-7a97-e053-2a95a90ab15ed5df1a46-08a1-2889-e053-2a95a90a6a0b2022-01-18WarningsExact identifier
spl id: d5df10bc-16ff-7a97-e053-2a95a90ab15e
spl set id: d5df1a46-08a1-2889-e053-2a95a90a6a0b

Reported adverse events (FAERS/openFDA)#

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