LBEL PROTEGE EXPERT- ensulizole, octinoxate, octisalate, oxybenzone, and titanium dioxide lotion 
Ventura Corporation Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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L'BEL
PROTÈGE
EXPERT
moisturizing face
protector lotion
SPF 40

Drug Facts

Active Ingredients

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

Purpose

Sunscreen

Uses

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

Other information

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 + +

Principal Display Panel - 50 ml Carton
LBEL  PROTEGE EXPERT
ensulizole, octinoxate, octisalate, oxybenzone, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-027
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-027-011 mL in 1 PACKET
2NDC:13537-027-031 in 1 BOX
2NDC:13537-027-025 mL in 1 BOTTLE
3NDC:13537-027-051 in 1 BOX
3NDC:13537-027-0450 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35208/10/2011
Labeler - Ventura Corporation Ltd. (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A.880160197MANUFACTURE

Revised: 8/2011
Document Id: dd5be4e2-fa42-4add-bdb3-a7e27bdf2eb1
Set id: bb188f57-a53b-4cde-9abb-c97c576596e8
Version: 1
Effective Time: 20110811
 
Ventura Corporation Ltd.