LBEL ESSENTIAL DEEP MOISTURIZING AND OXYGENATING SPF 20 NORMAL TO OILY SKIN- avobenzone, octinoxate, octisalate, and octocrylene 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 ESSENTIAL deep moisturizing and oxygenating lotion SPF 20 normal to oily skin

Drug Facts

Active IngredientsPurpose
AVOBENZONE (3.00 %)Sunscreen
OCTINOXATE (3.00 %)Sunscreen
OCTISALATE (5.00 %)Sunscreen
OCTOCRYLENE (6.00 %)Sunscreen

Uses

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

Other information

Inactive ingredients

WATER, GLYCERIN, BUTYLENE GLYCOL, ALUMINUM STARCH OCTENYLSUCCINATE, C12-15 ALKYL BENZOATE, CYCLOHEXASILOXANE, CETEARYL ALCOHOL, DIMETHICONE, TOCOPHERYL ACETATE, GLYCERYL STEARATE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, CETYL ALCOHOL, CETEARETH-20, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, FRAGRANCE, XANTHAN GUM, PEG-75 STEARATE, ENANTIA CHLORANTHA BARK EXTRACT, METHYLPROPANEDIOL, BHT, TETRASODIUM EDTA, SACCHAROMYCES LYSATE, CETETH-20, STEARETH-20, SILANEDIOL SALICYLATE, SODIUM HYDROXIDE, TROMETHAMINE, METHYL PERFLUOROBUTYL ETHER, ISODODECANE, DISODIUM SUCCINATE, SILICA, GLUTAMIC ACID, GLYCINE, THREONINE, VALINE , POLYSILICONE-11, OLEANOLIC ACID, BLUE 1, DECYL GLUCOSIDE.

PUERTO RICO: Dist. by Ventura Corp, Ltd., San Juan,
Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Box

L'BEL

ESSENTIAL

deep moisturizing
and oxygenating
lotion SPF 20
normal to oily skin

50 ml e (1.6 fl.oz.)

PRINCIPAL DISPLAY PANEL - 50 mL Tube Box
LBEL ESSENTIAL DEEP MOISTURIZING AND OXYGENATING SPF 20 NORMAL TO OILY SKIN 
avobenzone, octinoxate, octisalate, and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-637
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.03 g  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.03 g  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.05 g  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.06 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PEG-75 STEARATE (UNII: OT38R0N74H)  
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
CETETH-20 (UNII: I835H2IHHX)  
STEARETH-20 (UNII: L0Q8IK9E08)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TROMETHAMINE (UNII: 023C2WHX2V)  
METHYL PERFLUOROBUTYL ETHER (UNII: H637A50B7U)  
ISODODECANE (UNII: A8289P68Y2)  
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLUTAMIC ACID (UNII: 3KX376GY7L)  
GLYCINE (UNII: TE7660XO1C)  
THREONINE (UNII: 2ZD004190S)  
VALINE (UNII: HG18B9YRS7)  
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-637-021 in 1 BOX
1NDC:13537-637-0150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:13537-637-041 in 1 BOX
2NDC:13537-637-035 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:13537-637-061 in 1 CARTON
3NDC:13537-637-051 mL in 1 PACKET; Type 0: Not a Combination Product
4NDC:13537-637-081 in 1 CARTON
4NDC:13537-637-070.25 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35203/09/2015
Labeler - Ventura Corporation LTD (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-637)

Revised: 3/2015
Document Id: 6f7530ab-de1f-4e84-a4bb-4fc1bfc61eec
Set id: 6ee0cf46-4ca1-470e-a9ba-2f0317ce83e7
Version: 1
Effective Time: 20150317
 
Ventura Corporation LTD