FDA.reportPublic FDA data

Soleil Toujours

Manufacturer
Prime Enterprises, Inc.
Effective date
2022-01-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:16:13

Label at a glance#

ProductSoleil Toujours Broad Spectrum SPF 30
Active ingredientHOMOSALATE, AVOBENZONE, OCTISALATE, OCTOCRYLENE
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

Apply liberally 15 minutes before sun exposure. Reapply: After 40 mins 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, regulary use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, esp...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%, Homosalate 7.5%, Octisalate 5%, Octocrylene 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.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure.

Reapply:

  • After 40 mins 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, regulary use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

  • Limit time in the sun, espescially from 10 a.m. - 2p.m.
  • Wear long sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Alumina, Butylene/Ethylene/Styrene Copolymer, Cocos Nucifera (Coconut) Oil, Ethylene/Propylene/Styrene Copolymer, Ethylhexylglycerin, Euterpe Oleracea Fruit Oil, Fragrance, Gossypium Herbaceum (Cotton) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Iron Oxides, Isododecane, Mica, Phenoxyethanol, Theobroma Grandiflorum Seed Butter, Titanium Dioxide, Tocopheryl Acetate

Other information:

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun.

Soleil Toujours Solstice Shimmer Oil Broad Spectrum SPF 30

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 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-051658443-0516-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
THEOBROMA GRANDIFLORUM SEED BUTTERI711F13FXMIACT
COCONUT OILQ9L0O73W7LIACT
LEVANT COTTON SEED550E4N439VIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ACAI OILZ0W6766A2WIACT
SUNFLOWER OIL3W1JG795YIIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALUMINUM OXIDELMI26O6933IACT
ISODODECANEA8289P68Y2IACT
FERRIC OXIDE RED1K09F3G675IACT
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
HOMOSALATEV06SV4M95SACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
d5c89ddc-516a-51c0-e053-2a95a90aadbfd5c8c376-e83f-413c-e053-2a95a90a6eba2022-01-17WarningsExact identifier
spl id: d5c89ddc-516a-51c0-e053-2a95a90aadbf
spl set id: d5c8c376-e83f-413c-e053-2a95a90a6eba

Reported adverse events (FAERS/openFDA)#

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