LBEL LEDERM 55PLUS JOUR SPF 15 FACIAL TREATMENT AGAINST ADVANCED SIGNS OF AGING DAY - ALL SKIN TYPES- avobenzone, octisalate, octocrylene, and oxybenzone cream

LBEL LEDERM 55plus Jour by

Drug Labeling and Warnings

LBEL LEDERM 55plus Jour by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation LTD., Bel Star S.A. (Colombia), Yobel Supply Chain Management S.A. (Peru). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
AVOBENZONE 3.0%	Sunscreen
OCTISALATE 5.0%	Sunscreen
OCTOCRYLENE 3.0%	Sunscreen
OXYBENZONE 5.0%	Sunscreen

Uses

• Helps prevent sunburn.

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

• Apply liberally and evenly 15 minutes before sun exposure.
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating.
• Children under 6 months of age: Ask a doctor

Other information

• Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

AQUA (WATER), GLYCERIN, C12-15 ALKYL BENZOATE, DIMETHICONE, DICAPRYLYL CARBONATE, PHENETHYL BENZOATE, CYCLOPENTASILOXANE, POTASSIUM CETYL PHOSPHATE, CETEARYL ALCOHOL, CYCLOHEXASILOXANE, PENTYLENE GLYCOL, TRILAURETH-4 PHOSPHATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, HYDROGENATED PALM GLYCERIDES, METHYL METHACRYLATE CROSSPOLYMER, PHENOXYETHANOL, CETYL ALCOHOL, GLYCERYL STEARATE, ALBIZIA JULIBRISSIN BARK EXTRACT, BIS-VINYL DIMETHICONE/DIMETHICONE COPOLYMER, PEG-75 STEARATE, XANTHAN GUM, CETEARETH-20, CHLORPHENESIN, PARFUM (FRAGRANCE), ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CETETH-20, STEARETH-20, TETRASODIUM EDTA, ACACIA SENEGAL GUM, CICHORIUM INTYBUS ROOT EXTRACT (CICHORIUM INTYBUS (CHICORY) ROOT EXTRACT), ALARIA ESCULENTA EXTRACT, SODIUM HYDROXIDE, ALCOHOL, LECITHIN, HYDROLYZED SOYBEAN FIBER, HYDROXYPROPYL CYCLODEXTRIN, FOLIC ACID, HYDROLYZED CORN PROTEIN, PALMITOYL TRIPEPTIDE-38

SPL UNCLASSIFIED SECTION

P.R.: Distributed by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 50 g Bottle Carton

L'BEL
LEDERM

FORMULA CREATED BY FRNECH DERMATOLOGISTS
SKIN
EXPERTS

55+ JOUR

facial treatment
against advanced
signs of aging
day cream SPF 15
all skin types

50 g e (1.7 oz.)

INGREDIENTS AND APPEARANCE

LBEL LEDERM 55PLUS JOUR   SPF 15 FACIAL TREATMENT AGAINST ADVANCED SIGNS OF AGING DAY - ALL SKIN TYPES
avobenzone, octisalate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-448
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.03 g  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.05 g  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.03 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PHENETHYL BENZOATE (UNII: 0C143929GK)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)
PEG-75 STEARATE (UNII: OT38R0N74H)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETETH-20 (UNII: I835H2IHHX)
STEARETH-20 (UNII: L0Q8IK9E08)
EDETATE SODIUM (UNII: MP1J8420LU)
ACACIA (UNII: 5C5403N26O)
CHICORY ROOT (UNII: 090CTY533N)
ALARIA ESCULENTA (UNII: EJ9JK8J58D)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALCOHOL (UNII: 3K9958V90M)
FOLIC ACID (UNII: 935E97BOY8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-448-01	1 g in 1 PACKET
2	NDC: 13537-448-04	1 in 1 BOX
2	NDC: 13537-448-03	5 g in 1 BOTTLE, PLASTIC
3	NDC: 13537-448-06	1 in 1 BOX
3	NDC: 13537-448-05	50 g in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/01/2013

Labeler - Ventura Corporation LTD. (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-448)

Establishment
Name	Address	ID/FEI	Business Operations
Yobel Supply Chain Management S.A. (Peru)		934116930	MANUFACTURE(13537-448)