Dosage and administration
Apply smoothly every morning before sun exposure and as needed.
LBEL UV DEFENSE 365
- Manufacturer
- Ventura Corporation Ltd. (San Juan, P.R) | MF Productions Saumur
- Effective date
- 2011-08-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:29:25
Label at a glance#
ProductLBEL UV DEFENSE 365
Active ingredientHomosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, Zinc Oxide
Label structure8 sections
Storage and handling
High sun protection product. Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun. Apply the product with your fingertips. Use every morning before exposure to UVA and UVB radiation or whenever needed.
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active Ingredients | Purpose |
|---|---|
| Homosalate (5 %) | Sunscreen |
| Octinoxate (7 %) | Sunscreen |
| Octisalate (5 %) | Sunscreen |
| Oxybenzone (4 %) | Sunscreen |
| Titanium Dioxide (6.24%) | Sunscreen |
| Zinc Oxide (3.88%) | Sunscreen |
Uses
- Helps prevent sunburn.
- higher SPF gives more sunburn protection
Warnings
- For external use only.
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 and irritation develops and lasts.
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 smoothly every morning before sun exposure and as needed.
Other information
- High sun protection product.
- Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun.
- Apply the product with your fingertips. Use every morning before exposure to UVA and UVB radiation or whenever needed.
Inactive ingredients
Aqua (water), dicaprylyl carbonate, propylheptyl caprylate, glyceryl stearate, potassium cetyl phosphate, alcohol denat., cyclohexasiloxane, polymethylsilsesquioxane, glycerin, sorbitan stearate, bis-ethylhexyl hydroxydimethoxy benzylmalonate, dimethicone, tocopheryl acetate, ceteareth-20, silica, methicone, cetearyl alcohol, ceteareth-12, cetyl palmitate, peg-8, propylene glycol, phenoxyethanol, methylparaben, ambrosia peruviana leaf extract, xantham gum, caprylyl glycol, mica, propylparaben, triethoxycaprylylsilane, butylene glycol, helianthus annuus (sunflower) seed extract, ppg-1-peg-9-lauryl glycol ether, chlorphenesin, cyclopentasiloxane, hedera helix (ivy) leaf/stem extract, phytic acid, sodium polyacrylate.
SPL UNCLASSIFIED SECTION
Dist. by Ventura Corporation, Ltd, San Juan, Puerto Rico 00926.
PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton
L'BEL
UV DÉFENSE 365
oil-free daily protective
facial lotion SPF 50
UVB SPF 50
UVA PA +++
30 ml e (1 fl.oz.)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 13537-402-02 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-cff5-8e05-e053-dbdaa90a074a | L'BEL UV DÉFENSE 365 |
| 13537-402-04 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-cff5-8e05-e053-dbdaa90a074a | L'BEL UV DÉFENSE 365 |
| 13537-402-05 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-cff5-8e05-e053-dbdaa90a074a | L'BEL UV DÉFENSE 365 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 13537-402-01 | LBEL UV DEFENSE 365 | 30 mL in 1 BOTTLE | LOTION | 30 | 1 | |
| 13537-402-02 | LBEL UV DEFENSE 365 | 1 in 1 BOX | LOTION | 1 | 1 | |
| 13537-402-03 | LBEL UV DEFENSE 365 | 3 mL in 1 BOTTLE | LOTION | 3 | 1 | |
| 13537-402-04 | LBEL UV DEFENSE 365 | 1 in 1 BOX | LOTION | 1 | 1 | |
| 13537-402-05 | LBEL UV DEFENSE 365 | 1 mL in 1 PACKET | LOTION | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 13537-402 | LBEL UV DEFENSE 365 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [VENTURA CORPORATION LTD. (SAN JUAN, P.R)] | 1 | Legacy NDC, 5 package rows | 20110902_0873d6a1-55df-415e-8f95-2d08ef7ee84f.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Homosalate | ACTIVE INGREDIENT | V06SV4M95S | 1 | |
| Octinoxate | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| Octisalate | ACTIVE INGREDIENT | 4X49Y0596W | 1 | |
| Oxybenzone | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| Titanium Dioxide | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| Zinc Oxide | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| Homosalate | ACTIVE MOIETY | V06SV4M95S | 1 | |
| Octinoxate | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| Octisalate | ACTIVE MOIETY | 4X49Y0596W | 1 | |
| Oxybenzone | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| Titanium Dioxide | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| Zinc Oxide | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| ambrosia peruviana leaf | INACTIVE INGREDIENT | 458F79CGBF | 1 | |
| butylene glycol | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| caprylyl glycol | INACTIVE INGREDIENT | 00YIU5438U | 1 | |
| ceteareth-12 | INACTIVE INGREDIENT | 7V4MR24V5P | 1 | |
| cetostearyl alcohol | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| cetyl palmitate | INACTIVE INGREDIENT | 5ZA2S6B08X | 1 | |
| chlorphenesin | INACTIVE INGREDIENT | I670DAL4SZ | 1 | |
| cyclomethicone 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 1 | |
| cyclomethicone 6 | INACTIVE INGREDIENT | XHK3U310BA | 1 | |
| dicaprylyl carbonate | INACTIVE INGREDIENT | 609A3V1SUA | 1 | |
| dimethicone | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| glyceryl monostearate | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| hedera helix top | INACTIVE INGREDIENT | 379040L9FW | 1 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| mica | INACTIVE INGREDIENT | V8A1AW0880 | 1 | |
| phenoxyethanol | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| phytic acid | INACTIVE INGREDIENT | 7IGF0S7R8I | 1 | |
| polyethylene glycol 400 | INACTIVE INGREDIENT | B697894SGQ | 1 | |
| polyoxyl 20 cetostearyl ether | INACTIVE INGREDIENT | YRC528SWUY | 1 | |
| potassium cetyl phosphate | INACTIVE INGREDIENT | 03KCY6P7UT | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| propylheptyl caprylate | INACTIVE INGREDIENT | 991Z19V2OD | 1 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| sorbitan monostearate | INACTIVE INGREDIENT | NVZ4I0H58X | 1 | |
| sunflower seed | INACTIVE INGREDIENT | R9N3379M4Z | 1 | |
| triethoxycaprylylsilane | INACTIVE INGREDIENT | LDC331P08E | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| xanthan gum | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Products#
Every source-derived product name is available through these pages.
- LBEL UV DEFENSE 365
- 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
- cyclomethicone 6
- glycerin
- sorbitan monostearate
- dimethicone
- polyoxyl 20 cetostearyl ether
- silicon dioxide
- cetostearyl alcohol
- ceteareth-12
- cetyl palmitate
- polyethylene glycol 400
- propylene glycol
- phenoxyethanol
- methylparaben
- ambrosia peruviana leaf
- xanthan gum
- caprylyl glycol
- mica
- propylparaben
- triethoxycaprylylsilane
- butylene glycol
- sunflower seed
- chlorphenesin
- cyclomethicone 5
- hedera helix top
- phytic acid
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 13537-402 | 13537-402-01, 13537-402-02, 13537-402-03, 13537-402-04, 13537-402-05 |
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 |
|---|---|---|---|---|---|---|
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / PARENTERAL | 2 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, EXTENDED RELEASE / ORAL | 529 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL / TOPICAL | 19.2 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED / ORAL | 25 mg | ||
| polyethylene glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SOLUTION / OPHTHALMIC | 46 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / NASAL | 25 mg/1ml | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | LOZENGE / ORAL | 1264 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRALESIONAL | 0.15 %w/v | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | DROPS / AURICULAR (OTIC) | 0.01 %w/w | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | ENEMA / RECTAL | 0.18 %w/v | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / TOPICAL | 8 %w/w | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | DROPS / NASAL | 26 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / TOPICAL | 0.75 %w/v | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SOLUTION / ORAL | 10 mg/5ml | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / RESPIRATORY (INHALATION) | 0.01 %w/w | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SUSPENSION / ORAL | 75 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SYRUP / ORAL | 81 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / TOPICAL | 4886 mg | ||
| polyethylene glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | INJECTION / INTRAMUSCULAR | 406 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAMUSCULAR | 7459 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, SUSPENSION / INTRAMUSCULAR | 1 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | LOTION / TOPICAL | 177 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CLOTH / TOPICAL | 0.03 mg/mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | LIQUID / TOPICAL | 0.1 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / RECTAL | 271 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SPRAY / TOPICAL | 0.2 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg | ||
| polyethylene glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | SOLUTION / ORAL | 84 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| polyethylene glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE, DELAYED RELEASE / ORAL | 26 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT, AUGMENTED / TOPICAL | 714 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | GEL / TOPICAL | 24 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SHAMPOO / TOPICAL | 0.15 %w/w | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | TABLET, EXTENDED RELEASE / ORAL | 0.12 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | CAPSULE, EXTENDED RELEASE / ORAL | 2 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | POWDER / ORAL | 275 mg | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 6 mg | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | CREAM / TOPICAL | 46 mg | ||
| sorbitan monostearate | SORBITAN MONOSTEARATE | NVZ4I0H58X | CREAM / VAGINAL | 100 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IRRIGATION | 2 %w/v | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY, METERED / NASAL | 240 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | JELLY / TOPICAL | 180 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | DROPS / AURICULAR (OTIC) | 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 |
|---|---|---|---|---|---|---|
| 38b1a1b0-a33d-404c-8214-b9cbf57a478c | 0873d6a1-55df-415e-8f95-2d08ef7ee84f | 2011-08-25 | Warnings | 38b1a1b0-a33d-404c-8214-b9cbf57a478c 0873d6a1-55df-415e-8f95-2d08ef7ee84f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.