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 Broad Spectrum SPF-15
- Manufacturer
- The Soleil Group, LLC | Pure Source
- Effective date
- 2015-02-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:41:51
Label at a glance#
ProductSoleil Broad Spectrum SPF-15
Active ingredientOCTINOXATE, OCTISALATE, ZINC OXIDE
Label structure8 sections
Dosage and administration
Apply liberally 20 minutes prior to sun exposure. Do not spray onto face. Spray into hands and apply to face. Use in well-ventilated areas. Reapply: immediately after swimming, sweating or towel drying and 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...
Storage and handling
May stain or damage some fabrics or surfaces. Avoid long term storage above 40°C (120°F). Protect this product from excessive heat and direct sun.
Label contents#
Full prescribing information#
WARNINGS SECTION
For external use only. Flammable: Do not use
near heat, flame, or while smoking. Do not use on damaged
or broken skin. When using this product keep out of eyes.
Rinse with water to remove. Stop use and ask a doctor if rash
occurs. Keep out of reach of children. If the product is
swallowed, get medical help or contact a Poison Control
Center immediately.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
OTC - ACTIVE INGREDIENT SECTION
Octinoxate 5.0%, Octisalate
3.0%, Zinc Oxide 2.5%
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.
OTC - PURPOSE SECTION
Sunscreen
Directions
Apply liberally 20 minutes prior to sun
exposure. Do not spray onto face. Spray into hands and apply
to face. Use in well-ventilated areas. Reapply: immediately
after swimming, sweating or towel drying and 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
May stain or damage some fabrics or
surfaces. Avoid long term storage above 40°C (120°F).
Protect this product from excessive heat and direct sun.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ZINC CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69630-001-15 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-1c7e-f424-e053-dadaa90a57ce | Soleil SPF-15 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69630-001-15 | Soleil Broad Spectrum SPF-15 | 177.4 mL in 1 BOTTLE, SPRAY | SPRAY | 177.4 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | 1 | |
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 1 | |
| ZINC CATION | ACTIVE MOIETY | 13S1S8SF37 | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 1 | |
| ARTEMISIA PALLENS WHOLE | INACTIVE INGREDIENT | 39JKR5IL2G | 1 | |
| CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE | INACTIVE INGREDIENT | U73D397055 | 1 | |
| CARROT | INACTIVE INGREDIENT | L56Z1JK48B | 1 | |
| CETEARYL OLIVATE | INACTIVE INGREDIENT | 58B69Q84JO | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| CITRUS AURANTIUM FLOWER OIL | INACTIVE INGREDIENT | D4BGE91OXH | 1 | |
| CITRUS AURANTIUM FRUIT | INACTIVE INGREDIENT | DQD16J2B5O | 1 | |
| CITRUS LIMON FRUIT OIL | INACTIVE INGREDIENT | 0HNC1J1YED | 1 | |
| CITRUS NOBILIS | INACTIVE INGREDIENT | 8MFF77J91V | 1 | |
| CITRUS SINENSIS FRUIT OIL | INACTIVE INGREDIENT | WV48LBL15Q | 1 | |
| ETHYL ACETOACETATE | INACTIVE INGREDIENT | IZP61H3TB1 | 1 | |
| EUCALYPTUS GLOBULUS WHOLE | INACTIVE INGREDIENT | SI1P2XF3M3 | 1 | |
| FUCUS VESICULOSUS | INACTIVE INGREDIENT | 535G2ABX9M | 1 | |
| GLUCONOLACTONE | INACTIVE INGREDIENT | WQ29KQ9POT | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| GREEN TEA LEAF | INACTIVE INGREDIENT | W2ZU1RY8B0 | 1 | |
| ISOAMYL ACETATE | INACTIVE INGREDIENT | Z135787824 | 1 | |
| ISOBUTYL ACETATE | INACTIVE INGREDIENT | 7CR47FO6LF | 1 | |
| JASMINUM SAMBAC WHOLE | INACTIVE INGREDIENT | 1Z81V275I0 | 1 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | 1 | |
| LEVOMENOL | INACTIVE INGREDIENT | 24WE03BX2T | 1 | |
| METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER | INACTIVE INGREDIENT | 39DK5WQ2PR | 1 | |
| OPOPANAX CHIRONIUM WHOLE | INACTIVE INGREDIENT | 0LGQ3H5EXR | 1 | |
| PEG/PPG-17/6 COPOLYMER | INACTIVE INGREDIENT | P5QZM4T259 | 1 | |
| PIPERONAL | INACTIVE INGREDIENT | KE109YAK00 | 1 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | 1 | |
| PROPANEDIOL | INACTIVE INGREDIENT | 5965N8W85T | 1 | |
| SALVIA SCLAREA SEED OIL | INACTIVE INGREDIENT | JK0RP5O3HW | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| SORBITAN OLIVATE | INACTIVE INGREDIENT | MDL271E3GR | 1 | |
| SUNFLOWER OIL | INACTIVE INGREDIENT | 3W1JG795YI | 1 | |
| TETRAHEXYLDECYL ASCORBATE | INACTIVE INGREDIENT | 9LBV3F07AZ | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Soleil Broad Spectrum SPF-15
- Octinoxate, Octisalate, Zinc Oxide
- OCTINOXATE
- OCTISALATE
- ZINC OXIDE
- ZINC CATION
- METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER
- FUCUS VESICULOSUS
- ALOE VERA LEAF
- water
- ARTEMISIA PALLENS WHOLE
- LEVOMENOL
- GREEN TEA LEAF
- CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE
- CETYL ALCOHOL
- CETEARYL OLIVATE
- CITRUS AURANTIUM FLOWER OIL
- CITRUS AURANTIUM FRUIT
- CITRUS LIMON FRUIT OIL
- CITRUS NOBILIS
- CITRUS SINENSIS FRUIT OIL
- CARROT
- ETHYL ACETOACETATE
- EUCALYPTUS GLOBULUS WHOLE
- GLUCONOLACTONE
- GLYCERIN
- SUNFLOWER OIL
- PIPERONAL
- ISOAMYL ACETATE
- ISOBUTYL ACETATE
- JASMINUM SAMBAC WHOLE
- LECITHIN, SOYBEAN
- OPOPANAX CHIRONIUM WHOLE
- POLYSORBATE 20
- PEG/PPG-17/6 COPOLYMER
- SALVIA SCLAREA SEED OIL
- SODIUM BENZOATE
- SORBITAN OLIVATE
- TETRAHEXYLDECYL ASCORBATE
- .ALPHA.-TOCOPHEROL ACETATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69630-001 | 69630-001-15 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | AEROSOL, FOAM / TOPICAL | 3.7 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION / ORAL | 320 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | TABLET, FILM COATED / ORAL | 0.35 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CREAM / VAGINAL | 200 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET, EXTENDED RELEASE / ORAL | 20 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | INJECTION / INTRAMUSCULAR | 864 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, EXTENDED RELEASE / ORAL | 132 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | SOLUTION / TOPICAL | 15 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | POWDER, FOR SUSPENSION / ORAL | 1.3 mg/5ml | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | EMULSION / TOPICAL | 2 %w/w | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | PASTE / ORAL | 28 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / ORAL | 660 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GRANULE, EFFERVESCENT / ORAL | 60 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / VAGINAL | 0.75 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | CAPSULE / ORAL | 20 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | AEROSOL, FOAM / VAGINAL | 3 %w/w | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | OINTMENT / TOPICAL | 7 %w/w | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | SUPPOSITORY / VAGINAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| GLUCONOLACTONE | GLUCONOLACTONE | WQ29KQ9POT | SPONGE / TOPICAL | ADJ PH | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | FILM / BUCCAL | 1 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET / ORAL | 8 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION/ DROPS / ORAL | 23 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / TOPICAL | 0.1 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION, EXTENDED RELEASE / ORAL | 24 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GEL / TOPICAL | 5 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | TAMPON / VAGINAL | 64.8 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, COATED / ORAL | 0.25 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | SPRAY, METERED / NASAL | 40 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION, SOLUTION / INTRAVENOUS | 30 mg | ||
| GLUCONOLACTONE | GLUCONOLACTONE | WQ29KQ9POT | SOLUTION / TOPICAL | 0.3 %w/w | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | FILM / BUCCAL | 0.09 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GRANULE / ORAL | NA | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL / TOPICAL | 1.16 %w/w | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION / INTRAMUSCULAR | 1.62 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | CREAM / TOPICAL | 0.2 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, EMULSION / INTRAVENOUS | 24100 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SUSPENSION / SUBCUTANEOUS | 1.6 %w/v | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | CAPSULE / ORAL | 2 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, EXTENDED RELEASE / ORAL | NA |
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 |
|---|---|---|---|---|---|---|
| 5973fb6f-10df-4b7b-9d62-fc7ea4ffb845 | 33e4bbda-0f86-4b42-b7bd-5317ef86d36c | 2015-02-13 | Warnings | 5973fb6f-10df-4b7b-9d62-fc7ea4ffb845 33e4bbda-0f86-4b42-b7bd-5317ef86d36c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.