L'BEL DEFENSE 365 Oil-Free Daily Protective Facial Lotion SPF 50

Manufacturer
Ventura International, LTD | MF Productions
Effective date
2012-03-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:31:18

Label at a glance#

ProductLBEL DEFENSE 365 Daily Protective Facial SPF 50
Active ingredientHOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Indications and uses

Helps prevent sunburn.

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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate (5%)
Octinoxate (7.0%)
Octisalate (5.0%)
Oxybenzone (4.0%)
Titanium Dioxide (6.24%)
Zinc Oxide (3.92%)

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.

Warnings

WARNINGS 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.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes.  Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), dicaprylyl carbonate, propylheptyl caprylate, glyceryl stearate, potassium cetyl phosphate, alcohol denat., cyclohexasiloxane, polymethylsilsesquioxane, glycerin, sorbitan stearate, bis0ethylhexyl 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, mica, propylparaben, butylene glycol, helianthus annuus seed extract (helianthus annuus (sunflower) seed extract), ppg-1-peg-9-lauryl glycol ether, chlorophenesin, triethoxycaprylylsilane, cyclopentasiloxane, hedera helix leaf/stem extract (hedera helix (ivy) leaf/stem extract), phytic acid, sodium polyacrylate.

Purpose

OTC - PURPOSE SECTION

Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

L'BEL  DEFENSE 365 oil-free protective facial lotion SPF 50   30ml e (1 fl. oz.)

US: Dist. by Ventural Internationa Ltd.  DBA Bellcorp USA, San Francisco, CA 94111

P.R. Dist. by Ventura Corporation Ltd., San Juan, Puerto Rico 00926  MADE IN FRANCE

L'BEL DEFENSE 365 Oil-Free Daily Protective Facial Lotion SPF 50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Defense36530 ml InnerDefense36530 ml Inner

Defense 36530 ml OuterDefense 36530 ml Outer

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43455-0001-0LBEL DEFENSE 365 Daily Protective Facial SPF 501 mL in 1 POUCHLOTION11
43455-0001-1LBEL DEFENSE 365 Daily Protective Facial SPF 503 mL in 1 TUBELOTION31
43455-0001-2LBEL DEFENSE 365 Daily Protective Facial SPF 5030 mL in 1 JARLOTION301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43455-0001LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VENTURA INTERNATIONAL, LTD]1Legacy NDC, 3 package rows20120404_297ba415-f131-4dd3-9457-ef5382389683.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HOMOSALATEACTIVE INGREDIENTV06SV4M95S1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
HOMOSALATEACTIVE MOIETYV06SV4M95S1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
AMBROSIA PERUVIANA LEAFINACTIVE INGREDIENT458F79CGBF1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CETEARETH-12INACTIVE INGREDIENT7V4MR24V5P1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S1
CETYL PALMITATEINACTIVE INGREDIENT5ZA2S6B08X1
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZ1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BA1
DICAPRYLYL CARBONATEINACTIVE INGREDIENT609A3V1SUA1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
FYTIC ACIDINACTIVE INGREDIENT7IGF0S7R8I1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
HEDERA HELIX LEAFINACTIVE INGREDIENTZP9XFG71A71
HELIANTHUS ANNUUS SEED WAXINACTIVE INGREDIENT42DG15CHXV1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
MICAINACTIVE INGREDIENTV8A1AW08801
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUY1
POTASSIUM CETYL PHOSPHATEINACTIVE INGREDIENT03KCY6P7UT1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PROPYLHEPTYL CAPRYLATEINACTIVE INGREDIENT991Z19V2OD1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SODIUM POLYACRYLATE (8000 MW)INACTIVE INGREDIENT285CYO341L1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58X1
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08E1
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43455-000143455-0001-0, 43455-0001-1, 43455-0001-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Source Document#

Source XML · Source PDF

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.

Inactive ingredient links page 1 of 9 · 538 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER, FOR SOLUTION / ORAL126 mgExact identifier — unii candidate
79 equally ranked IID candidates
CETYL PALMITATECETYL PALMITATE5ZA2S6B08XCREAM / TOPICAL0.32 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHGEL / VAGINAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii candidate
49 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCONCENTRATE / ORAL3000 mgExact identifier — unii candidate
36 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LIQUID / TOPICAL1 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAMUSCULAR45 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / VAGINAL8 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCAPSULE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHERPOLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYSPRAY / TOPICAL2.42 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TENEMA / RECTAL0.18 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEFILM, SOLUBLE / ORAL1 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LOTION / TOPICAL177 mgExact identifier — unii candidate
21 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHDROPS / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / TOPICAL3.27 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / TOPICAL0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER / ORALNAExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL, METERED / TOPICAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / TOPICAL24 mgExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSYRUP / ORAL81 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUPPOSITORY / VAGINALNAExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / DENTALNAExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / TOPICAL5.28 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii candidate
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / RECTAL271 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAVENOUS45 mgExact identifier — unii candidate
79 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETROCHE / ORAL948 mgExact identifier — unii candidate
29 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCAPSULE, EXTENDED RELEASE / ORAL9.43 mgExact identifier — unii candidate
9 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR0.4 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, DELAYED RELEASE / ORAL40 mgExact identifier — unii candidate
49 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSWAB / TOPICAL5250 mgExact identifier — unii candidate
36 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSUPPOSITORY / RECTAL0.25 mg/mgExact identifier — unii candidate
36 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSYRUP / ORAL40 mgExact identifier — unii candidate
68 equally ranked IID candidates

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c028cd57-f5e6-4dc6-9640-bee5283e1051297ba415-f131-4dd3-9457-ef53823896832012-03-28WarningsExact identifier
spl id: c028cd57-f5e6-4dc6-9640-bee5283e1051
spl set id: 297ba415-f131-4dd3-9457-ef5382389683

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.