Indications and uses
Helps prevent sunburn.
L'BEL DÉFENSE 365 oil-free daily protective facial lotion SPF 50
- Manufacturer
- Ventura International LTD | Bel Star S.A. (Colombia)
- Effective date
- 2016-11-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:21:50
Label at a glance#
ProductLBEL DEFENSE 365 oil-free daily protective facial SPF 50
Active ingredientHomosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, Zinc Oxide
Label structure9 sections
Dosage and administration
Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor
Storage and handling
Protect the product in this container from excessive heat and direct sun.
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active Ingredients | Purpose |
|---|---|
| HOMOSALATE 5.00 % | Sunscreen |
| OCTINOXATE 7.00 % | Sunscreen |
| OCTISALATE 5.00 % | Sunscreen |
| OXYBENZONE 4.00 % | Sunscreen |
| TITANIUM DIOXIDE 6.24 % | Sunscreen |
| ZINC OXIDE 3.92% | Sunscreen |
Uses
- Helps prevent sunburn.
Warnings
SPL UNCLASSIFIED SECTION
- Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
- For external use only.
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 - STOP USE 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 swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply liberally and evenly 15 minutes before sun exposure.
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating.
- Children under 6 months of age: Ask a doctor
Other information
- Protect the product in this container from excessive heat and direct sun.
Inactive ingredients
WATER, DICAPRYLYL CARBONATE, PROPYLHEPTYL CAPRYLATE, GLYCERYL STEARATE, POTASSIUM CETYL PHOSPHATE, ALCOHOL DENAT., CYCLOHEXASILOXANE, POLYMETHYLSILSESQUIOXANE, GLYCERIN, SORBITAN STEARATE, BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE, DIMETHICONE, TOCOPHERYL ACETATE, SILICA, METHICONE, PEG-8, CETEARETH-12, CETEARETH-20, PROPYLENE GLYCOL, PHENOXYETHANOL, METHYLPARABEN, AMBROSIA PERUVIANA LEAF EXTRACT, CETEARYL ALCOHOL, CETYL PALMITATE, XANTHAN GUM, CAPRYLYL GLYCOL, PROPYLPARABEN, CHLORPHENESIN, BUTYLENE GLYCOL, HELIANTHUS ANNUUS (SUNFLOWER) SEED EXTRACT, MICA, PPG-1-PEG-9 LAURYL GLYCOL ETHER, TRIETHOXYCAPRYLYLSILANE, CYCLOPENTASILOXANE, HEDERA HELIX (IVY) LEAF/STEM EXTRACT, PHYTIC ACID, SODIUM POLYACRYLATE.
SPL UNCLASSIFIED SECTION
Dist. by Ventura Int Ltd. DBA
Belcorp USA, Miami, FL 33126
PRINCIPAL DISPLAY PANEL - 30 ml Tube Box
L'BEL
DÉFENSE 365
oil-free daily protective
facial lotion SPF 50
SPF 50
30 ml e (1 fl.oz.)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 14783-992-02 | 2025-03-28 | C162847 | 48780-1 | 9d75b9cf-de4a-f424-e053-dadaa90a57ce | L'BEL DÉFENSE 365 oil-free daily protective facial lotion SPF 50 |
| 14783-992-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-de4a-f424-e053-dadaa90a57ce | L'BEL DÉFENSE 365 oil-free daily protective facial lotion SPF 50 |
Products#
Every source-derived product name is available through these pages.
- LBEL DEFENSE 365 oil-free daily protective facial SPF 50
- Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, and Zinc Oxide
- Homosalate
- Octinoxate
- Octisalate
- Oxybenzone
- Titanium Dioxide
- Zinc Oxide
- Water
- Dicaprylyl Carbonate
- Propylheptyl Caprylate
- Glyceryl Monostearate
- Potassium Cetyl Phosphate
- Alcohol
- Cyclomethicone 6
- Glycerin
- Sorbitan Monostearate
- Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate
- Dimethicone
- .Alpha.-Tocopherol Acetate
- Silicon Dioxide
- Methicone (20 CST)
- Polyethylene Glycol 400
- Ceteareth-12
- Polyoxyl 20 Cetostearyl Ether
- Propylene Glycol
- Phenoxyethanol
- Methylparaben
- Ambrosia Peruviana Leaf
- Cetostearyl Alcohol
- Cetyl Palmitate
- Xanthan Gum
- Caprylyl Glycol
- Propylparaben
- Chlorphenesin
- Butylene Glycol
- Sunflower Seed
- Mica
- PPG-1-PEG-9 Lauryl Glycol Ether
- Triethoxycaprylylsilane
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 14783-992 | 14783-992-01, 14783-992-02 |
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 |
|---|---|---|---|---|---|---|
| e1e17eaf-b424-47e6-be5c-f01a9acba9cf | 50a3d6a4-ad62-4d35-a7c9-b7131d9e9ee0 | 2016-11-03 | Warnings | e1e17eaf-b424-47e6-be5c-f01a9acba9cf 50a3d6a4-ad62-4d35-a7c9-b7131d9e9ee0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.