LBEL DEFENSE 365 OIL-FREE DAILY PROTECTIVE FACIAL SPF 50- homosalate, octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide lotion

LBEL DEFENSE 365 oil-free daily protective facial SPF 50 by

Drug Labeling and Warnings

LBEL DEFENSE 365 oil-free daily protective facial SPF 50 by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

• 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 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 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 Bentura Corp, Ltd., San Juan, Puerto Rico 00926.

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.)

INGREDIENTS AND APPEARANCE

LBEL DEFENSE 365 OIL-FREE DAILY PROTECTIVE FACIAL SPF 50 
homosalate, octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-177
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	0.05 g  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.05 g  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.04 g  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0624 g  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0392 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
ALCOHOL (UNII: 3K9958V90M)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE (UNII: 7D4Q5YJ8NV)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHICONE (20 CST) (UNII: 6777U11MKT)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CETEARETH-12 (UNII: 7V4MR24V5P)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
AMBROSIA PERUVIANA LEAF (UNII: 458F79CGBF)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CHLORPHENESIN (UNII: I670DAL4SZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SUNFLOWER SEED (UNII: R9N3379M4Z)
MICA (UNII: V8A1AW0880)
PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
FYTIC ACID (UNII: 7IGF0S7R8I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-177-02	1 in 1 BOX	10/31/2016
1	NDC: 13537-177-01	30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	10/31/2016

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-177)