LBEL  DERMO CLARITE- avobenzone, ensulizole, octisalate, octocrylene, and oxybenzone lotion 
Ventura International 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
DERMO CLARITÉ

Drug Facts

Active Ingredients

Butyl methoxydibenzoylmethane 3.0%,

Ensulizole 3.0%,

Octisalate 5.0%,

Octocrylene 5.0%,

Oxybenzone 6.0%

Purpose

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 damage 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

aqua (water), dicaprylyl carbonate, cetearyl alcohol, phenethyl benzoate, triethanolamine, cyclopentasiloxane, propylene glycol, methyl methacrylate crosspolymer, sorbitan stearate, triethylhexanoin, potassium cetyl phosphate, phenoxyethanol, dimethicone, stearyl dimethicone, ceteareth-20, xanthan gum, chlorphenesin, parfum (fragrance), vigna aconitifolia seed extract, cetyl alcohol, dimethylmethoxy chromanyl palmitate, glyceryl stearate, methylparaben, sodium cocoyl glutamate, tetrasodium edta, peg-75 stearate, butylparaben, sorbic acid, ceteth-20, steareth-20.

US: Distributed by Ventura International Ltd,
San Francisco, CA 94111.

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box

L'BEL
DERMO CLARITÉ

clarifying and moisturizing
facial lotion with SPF 30

30 ml e (1 fl.oz.)

Principal Display Panel - 30 ml Bottle Box
LBEL   DERMO CLARITE
avobenzone, ensulizole, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-434
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.03 g  in 1 mL
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole0.03 g  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.05 g  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.05 g  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.06 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
dicaprylyl carbonate (UNII: 609A3V1SUA)  
alcohol (UNII: 3K9958V90M)  
phenethyl benzoate (UNII: 0C143929GK)  
trolamine (UNII: 9O3K93S3TK)  
cyclomethicone 5 (UNII: 0THT5PCI0R)  
propylene glycol (UNII: 6DC9Q167V3)  
sorbitan monostearate (UNII: NVZ4I0H58X)  
triethylhexanoin (UNII: 7K3W1BIU6K)  
potassium cetyl phosphate (UNII: 03KCY6P7UT)  
phenoxyethanol (UNII: HIE492ZZ3T)  
dimethicone (UNII: 92RU3N3Y1O)  
polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)  
xanthan gum (UNII: TTV12P4NEE)  
chlorphenesin (UNII: I670DAL4SZ)  
moth bean (UNII: H7938ON8E5)  
cetyl alcohol (UNII: 936JST6JCN)  
glyceryl monostearate (UNII: 230OU9XXE4)  
methylparaben (UNII: A2I8C7HI9T)  
edetate sodium (UNII: MP1J8420LU)  
peg-75 stearate (UNII: OT38R0N74H)  
butylparaben (UNII: 3QPI1U3FV8)  
sorbic acid (UNII: X045WJ989B)  
ceteth-20 (UNII: I835H2IHHX)  
steareth-20 (UNII: L0Q8IK9E08)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-434-011 in 1 BOX
1NDC:14783-434-0230 mL in 1 BOTTLE
2NDC:14783-434-041 in 1 BOX
23 mL in 1 BOTTLE
3NDC:14783-434-051 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35211/26/2011
Labeler - Ventura International Ltd. (603192787)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star, S. A.(Colombia)880160197MANUFACTURE(14783-434)
Establishment
NameAddressID/FEIBusiness Operations
Yobel Supply Chain Management (Peru)934116930MANUFACTURE(14783-434)

Revised: 11/2011
Document Id: 3cc7d79e-48a5-440a-a5e7-ca9048ee07f0
Set id: 7c0b3e24-fece-4227-89e3-6db7b3e0f6ec
Version: 1
Effective Time: 20111129
 
Ventura International Ltd.