LBEL PROTEGE EXPERT- ensulizole, octinoxate, octisalate, oxybenzone, and titanium dioxide lotion

LBEL by

Drug Labeling and Warnings

LBEL by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation Ltd., Bel Star S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Ensulizole 3%,
Octinoxate 7.5%,
Octisalate 5%,
Oxybenzone 6%,
Titanium dioxide 3.9%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• Provides high protection against sunburn
• Retains SPF after 40 minutes of activity in the water

Warnings

For external use only.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally before sun exposure and as needed

Other information

• Sun alert: Limiting sun exposure, waring protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

aqua (water), dicaprylyl carbonate, c12-15 alkyl benzoate, vp/eicosene copolymer, triethanolamine, methyl methacrylate crosspolymer, dimethicone, cyclopentasiloxane, cetearyl alcohol, sorbitan stearate, glyceryl stearate, potassium cetyl phosphate, tocopheryl acetate, cyclohexasiloxane, silica, trimethylsiloxysilicate, phenoxyethanol, methicone, ceteareth-20, methylparaben, xanthan gum, mannitol, parfum (fragrance), propylparaben, butylparaben, ethylparaben, isobutylparaben, arginine, cyclodextrin, dextrin, faex extract (yeast extract), histidine hydrochloride (histidine hci), pisum sativum extract (pisum sativum (pea) extract), acetyltyrosine, disodium succinate, khaya senegalensis bark extract, nicotinamide adenine dinucleotide, pyridoxine hci, aspartic acid.

PRINCIPAL DISPLAY PANEL - 50 ml Carton

L'BEL

PROTÈGE
EXPERT

moisturizing face
protector lotion
SPF 40

loción protectora
hidratante para rostro
FPS 40

WATER RESISTANT
RESISTENTE AL AGUA

50 ml e (1.7 fl.oz.)

UVB SPF
40
High Protection

UVA
PA + +

INGREDIENTS AND APPEARANCE

LBEL  PROTEGE EXPERT
ensulizole, octinoxate, octisalate, oxybenzone, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42)	Ensulizole	.03 g  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	.075 g  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	.05 g  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	.06 g  in 1 mL
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	.039 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dicaprylyl carbonate (UNII: 609A3V1SUA)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
dimethicone (UNII: 92RU3N3Y1O)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cetostearyl alcohol (UNII: 2DMT128M1S)
sorbitan monostearate (UNII: NVZ4I0H58X)
glyceryl monostearate (UNII: 230OU9XXE4)
potassium cetyl phosphate (UNII: 03KCY6P7UT)
cyclomethicone 6 (UNII: XHK3U310BA)
silicon dioxide (UNII: ETJ7Z6XBU4)
phenoxyethanol (UNII: HIE492ZZ3T)
polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)
methylparaben (UNII: A2I8C7HI9T)
xanthan gum (UNII: TTV12P4NEE)
mannitol (UNII: 3OWL53L36A)
propylparaben (UNII: Z8IX2SC1OH)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
isobutylparaben (UNII: 0QQJ25X58G)
arginine (UNII: 94ZLA3W45F)
yeast (UNII: 3NY3SM6B8U)
histidine monohydrochloride (UNII: 1D5Q932XM6)
pea (UNII: W4X7H8GYFM)
sodium succinate anhydrous (UNII: V8ZGC8ISR3)
khaya senegalensis bark (UNII: 1S7EDA839L)
nadide (UNII: 0U46U6E8UK)
pyridoxine hydrochloride (UNII: 68Y4CF58BV)
aspartic acid (UNII: 30KYC7MIAI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-027-01	1 mL in 1 PACKET
2	NDC: 13537-027-03	1 in 1 BOX
2	NDC: 13537-027-02	5 mL in 1 BOTTLE
3	NDC: 13537-027-05	1 in 1 BOX
3	NDC: 13537-027-04	50 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	08/10/2011

Labeler - Ventura Corporation Ltd. (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A.		880160197	MANUFACTURE