LBEL  PROTEGE EXPERT- 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
PROTEGE
EXPERT
moisturizing body
protector lotion
SPF 15

Drug Facts

Active Ingredients

Octinoxate 7.5%,
Octivsalate 5%,
Oxybenzone 6%,
Titanium dioxide 2.34%

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, methyl methacrylate crosspolymer, cyclopentasiloxane, dimethicone, cetearyl alcohol, sorbitan stearate, cyclohexasiloxane, glyceryl stearate, potassium cetyl phosphate, tocopheryl acetate, trimethylsiloxysilicate, phenoxyethanol, silica, 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), acetyl tyrosine, disodium succinate, khaya senegalensis bark extract, nicotinamide adenine dinucleotide, pyridoxine hci, aspartic acid

PRINCIPAL DISPLAY PANEL - 180 ml Bottle Carton

L'BEL

PROTÈGE
EXPERT

moisturizing body
protector lotion
SPF 15

WATER RESISTANT

180 ml e (6.3 fl.oz.)

UVB SPF
15
Moderate
Protection

UVA
PA ++

PRINCIPAL DISPLAY PANEL - 180 ml Bottle Carton
LBEL   PROTEGE EXPERT
octinoxate, octisalate, oxybenzone, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-026
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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.0234 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
dicaprylyl carbonate (UNII: 609A3V1SUA)  
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)  
trolamine (UNII: 9O3K93S3TK)  
cyclomethicone 5 (UNII: 0THT5PCI0R)  
dimethicone (UNII: 92RU3N3Y1O)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
sorbitan monostearate (UNII: NVZ4I0H58X)  
cyclomethicone 6 (UNII: XHK3U310BA)  
glyceryl monostearate (UNII: 230OU9XXE4)  
potassium cetyl phosphate (UNII: 03KCY6P7UT)  
phenoxyethanol (UNII: HIE492ZZ3T)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
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:13537-026-021 in 1 BOX
1NDC:13537-026-015 mL in 1 TUBE
2NDC:13537-026-041 in 1 BOX
2NDC:13537-026-0310 mL in 1 TUBE
3NDC:13537-026-061 in 1 BOX
3NDC:13537-026-05180 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
BelStar, S.A.880160197MANUFACTURE

Revised: 8/2011
Document Id: bab857e0-394d-4e26-af70-17e0cac83524
Set id: 7caef510-b52d-4efc-9384-c771b758da73
Version: 1
Effective Time: 20110811
 
Ventura Corporation Ltd.