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
Soleil Tojours
- Manufacturer
- Prime Enterprises Inc.
- Effective date
- 2020-08-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:25:15
Label at a glance#
ProductSoleil Tojours Broad Spectrum SPF 50
Active ingredientAVOBENZONE, OCTISALATE, HOMOSALATE
Label structure10 sections
Dosage and administration
Shake well before use with your eyes completly 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 beore sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures Spending time ine the sun increases your risk of skin cancer and early skin aging. ...
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredients
Avobenzone 3.0%
Homosalate 10.0%
Octisalate 5.0%
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
Flammable
Do not use near heat, flame or while smoking
Warnings
For external use only
Do not use on damaged or broken skin.
When using this product keep out of eyes. Rinse with water to remove. Keep away from face to avoid breathing it.
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 tempertures above 120 F
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
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.
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.
INACTIVE INGREDIENTS
Ascorbyl Palmitate, Bisabolol, Camellia Oleifera (Green Tea) Leaf Extract, Glycerin, Polyester-8, Porphyra Umbilicalis Extract, SD Alcohol 40-B, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water
Purpose
Sunscreen
Directions
- Shake well before use
- with your eyes completly 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 beore sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- Sun Protection Measures Spending time ine 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 valvue of 15 or higher and other sun protecion measures including:
- limit tim ein the sun, especially from 10am-2pm
- wear long sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
Other Information
- protect the product in this container from excessive heat and direct sunlight.
Questions or Comments?
Call 1-877-320-2381
Soleil Toujours Extreme face + scalp Sunscreen mist spf 50 Broad spectrum
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58443-0347-3 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3ee8-111a-e063-dadaa90a10e2 | Soleil Toujours Extreme Face + Scalp Sunscreen Mist SPF50 Broad Spectrum |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58443-0347-3 | Soleil TojoursBroad Spectrum SPF 50 | 59 mL in 1 BOTTLE | SPRAY | 59 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58443-0347 | SOLEIL TOJOURS BROAD SPECTRUM SPF 50 (OCTISALATE, AVOBENZONE, HOMOSALATE) SPRAY [PRIME ENTERPRISES INC.] | 1 | Legacy NDC, 1 package rows | 20200820_ad3c9f53-9dae-b6bd-e053-2a95a90a0693.zip |
Products#
Every source-derived product name is available through these pages.
- Soleil Tojours Broad Spectrum SPF 50
- Octisalate, Avobenzone, Homosalate
- ASCORBYL PALMITATE
- LEVOMENOL
- POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)
- ALCOHOL
- PORPHYRA UMBILICALIS
- TETRAHEXYLDECYL ASCORBATE
- ISOBORNYL ACRYLATE
- DIBUTYL MALEATE
- CAMELLIA OLEIFERA LEAF
- GLYCERIN
- ALPHA-TOCOPHEROL ACETATE
- WATER
- AVOBENZONE
- OCTISALATE
- HOMOSALATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58443-0347 | 58443-0347-3 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ad3cb1f9-19ed-310d-e053-2995a90a003b | ad3c9f53-9dae-b6bd-e053-2a95a90a0693 | 2020-08-19 | Warnings | ad3cb1f9-19ed-310d-e053-2995a90a003b ad3c9f53-9dae-b6bd-e053-2a95a90a0693 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.