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.
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.
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...
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.
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.
Keep out of reach of children
Octinoxate 5.0%, Octisalate
3.0%, Zinc Oxide 2.5%
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.
Sunscreen
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.
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.
| Class | Version | Type | Effective |
|---|---|---|---|
| ZINC CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69630-003-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7456-f424-e053-dadaa90a57ce | Soleil SPF-50 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69630-003-50 | Soleil Broad Spectrum SPF-50 | 177.4 mL in 1 BOTTLE, SPRAY | SPRAY | 177.4 | 2 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| AVOBENZONE | ACTIVE INGREDIENT | G63QQF2NOX | 2 | |
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 2 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | 2 | |
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 2 | |
| AVOBENZONE | ACTIVE MOIETY | G63QQF2NOX | 2 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 2 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 2 | |
| ZINC CATION | ACTIVE MOIETY | 13S1S8SF37 | 2 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 2 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 2 | |
| ARTEMISIA PALLENS WHOLE | INACTIVE INGREDIENT | 39JKR5IL2G | 2 | |
| CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE | INACTIVE INGREDIENT | U73D397055 | 2 | |
| CARROT | INACTIVE INGREDIENT | L56Z1JK48B | 2 | |
| CETEARYL OLIVATE | INACTIVE INGREDIENT | 58B69Q84JO | 2 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 2 | |
| CITRUS AURANTIUM FLOWER OIL | INACTIVE INGREDIENT | D4BGE91OXH | 2 | |
| CITRUS AURANTIUM FRUIT | INACTIVE INGREDIENT | DQD16J2B5O | 2 | |
| CITRUS LIMON FRUIT OIL | INACTIVE INGREDIENT | 0HNC1J1YED | 2 | |
| CITRUS NOBILIS | INACTIVE INGREDIENT | 8MFF77J91V | 2 | |
| CITRUS SINENSIS FRUIT OIL | INACTIVE INGREDIENT | WV48LBL15Q | 2 | |
| ETHYL ACETOACETATE | INACTIVE INGREDIENT | IZP61H3TB1 | 2 | |
| EUCALYPTUS GLOBULUS WHOLE | INACTIVE INGREDIENT | SI1P2XF3M3 | 2 | |
| FUCUS VESICULOSUS | INACTIVE INGREDIENT | 535G2ABX9M | 2 | |
| GLUCONOLACTONE | INACTIVE INGREDIENT | WQ29KQ9POT | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| GREEN TEA LEAF | INACTIVE INGREDIENT | W2ZU1RY8B0 | 2 | |
| ISOAMYL ACETATE | INACTIVE INGREDIENT | Z135787824 | 2 | |
| ISOBUTYL ACETATE | INACTIVE INGREDIENT | 7CR47FO6LF | 2 | |
| JASMINUM SAMBAC WHOLE | INACTIVE INGREDIENT | 1Z81V275I0 | 2 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | 2 | |
| LEVOMENOL | INACTIVE INGREDIENT | 24WE03BX2T | 2 | |
| METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER | INACTIVE INGREDIENT | 39DK5WQ2PR | 2 | |
| OPOPANAX CHIRONIUM WHOLE | INACTIVE INGREDIENT | 0LGQ3H5EXR | 2 | |
| PEG/PPG-17/6 COPOLYMER | INACTIVE INGREDIENT | P5QZM4T259 | 2 | |
| PIPERONAL | INACTIVE INGREDIENT | KE109YAK00 | 2 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | 2 | |
| PROPANEDIOL | INACTIVE INGREDIENT | 5965N8W85T | 2 | |
| SALVIA SCLAREA SEED OIL | INACTIVE INGREDIENT | JK0RP5O3HW | 2 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 2 | |
| SORBITAN OLIVATE | INACTIVE INGREDIENT | MDL271E3GR | 2 | |
| SUNFLOWER OIL | INACTIVE INGREDIENT | 3W1JG795YI | 2 | |
| TETRAHEXYLDECYL ASCORBATE | INACTIVE INGREDIENT | 9LBV3F07AZ | 2 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69630-003 | 69630-003-50 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, COATED / ORAL | 0.25 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | SUSPENSION / ORAL | 80 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET, FILM COATED / ORAL | 0.33 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / TOPICAL | 2.01 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, ORALLY DISINTEGRATING / ORAL | 9 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, FILM COATED / ORAL | 1 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | SPRAY, METERED / NASAL | 40 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | AEROSOL, FOAM / VAGINAL | 3 %w/w | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | CAPSULE / ORAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | GEL / TOPICAL | 5 %w/w | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GEL / RECTAL | 406 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / SUBCUTANEOUS | 450 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION / ORAL | 320 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION / INTRAMUSCULAR | 1.62 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SYSTEM / TOPICAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / RESPIRATORY (INHALATION) | 5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | SHAMPOO / TOPICAL | 8 %w/w | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION, EXTENDED RELEASE / ORAL | 24 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SUSPENSION / SUBCUTANEOUS | 1.6 %w/v | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION/ DROPS / ORAL | 23 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GEL / TOPICAL | 5 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | CREAM / TOPICAL | 0.2 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, EMULSION / INTRAVENOUS | 24100 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, COATED / ORAL | 0.2 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | TABLET / ORAL | 17 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | INJECTION, EMULSION / INTRAVENOUS | 0.1 %w/v | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | POWDER, FOR SUSPENSION / ORAL | 39 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / RECTAL | 440 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | TABLET, EXTENDED RELEASE / ORAL | 4.2 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | SUSPENSION / OPHTHALMIC | 0.05 %w/v | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / ORAL | 660 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | LOTION / TOPICAL | 2000 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | PASTE / DENTAL | 0.08 %w/w | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL / TOPICAL | 1.16 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | LOTION / TOPICAL | 1140 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | SUSPENSION / AURICULAR (OTIC) | 0.1 %w/v | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | INJECTION, SOLUTION / INTRAMUSCULAR | 4.8 %w/v | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SPONGE / TOPICAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / RECTAL | 17 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / VAGINAL | 60 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET, EXTENDED RELEASE / ORAL | 20 mg |
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 |
|---|---|---|---|---|---|---|
| 2f80bdd5-a876-401c-8115-516a085a3a3a | 4fd69e0b-f6b5-49bd-8b0e-534f7487f4d0 | 2015-02-26 | Warnings | 2f80bdd5-a876-401c-8115-516a085a3a3a 4fd69e0b-f6b5-49bd-8b0e-534f7487f4d0 |
Adverse event summaries are temporarily unavailable. Other product information remains available.