LBEL LEDERM 35PLUS JOUR SPF 15 FACIAL TREATMENT AGAINST FIRST SIGNS OF AGING DAY - NORMAL TO DRY SKIN- avobenzone, octisalate, octocrylene, and oxybenzone cream

LBEL LEDERM 35plus Jour by

Drug Labeling and Warnings

LBEL LEDERM 35plus 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), C12-15 ALKYL BENZOATE, GLYCERYL STEARATE, DIMETHICONE, CYCLOHEXASILOXANE, POTASSIUM CETYL PHOSPHATE, BUTYLENE GLYCOL, NIACINAMIDE, PEG-100 STEARATE, PENTYLENE GLYCOL, HYDROGENATED PALM GLYCERIDES, PHENOXYETHANOL, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, TOCOPHERYL ACETATE, SODIUM HYDROXIDE, XANTHAN GUM, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CHLORPHENESIN, PARFUM (FRAGRANCE), ACACIA SENEGAL GUM, DISODIUM EDTA, HYDROLYZED LUPINE PROTEIN, FAEX EXTRACT (YEAST EXTRACT), PRUNUS PERSICA LEAF EXTRACT (PRUNUS PERSICA (PEACH) LEAF EXTRACT), GLYCERIN, SILICA, CERATONIA SILIQUA SEED EXTRACT (CERATONIA SILIQUA (CAROB) SEED EXTRACT)

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 FRENCH DERMATOLOGISTS
SKIN
EXPERTS

35+ JOUR

facial treatment
against first
signs of aging
day cream SPF 15
normal to dry skin

50 g e (1.7 oz.)

INGREDIENTS AND APPEARANCE

LBEL LEDERM 35PLUS JOUR   SPF 15 FACIAL TREATMENT AGAINST FIRST SIGNS OF AGING DAY - NORMAL TO DRY SKIN
avobenzone, octisalate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-445
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)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NIACINAMIDE (UNII: 25X51I8RD4)
PEG-100 STEARATE (UNII: YD01N1999R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
XANTHAN GUM (UNII: TTV12P4NEE)
CHLORPHENESIN (UNII: I670DAL4SZ)
ACACIA (UNII: 5C5403N26O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
YEAST (UNII: 3NY3SM6B8U)
PRUNUS PERSICA LEAF (UNII: VN3501T41P)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CAROB (UNII: 5MG5Z946UO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-445-01	1 g in 1 PACKET
2	NDC: 13537-445-04	1 in 1 BOX
2	NDC: 13537-445-03	5 g in 1 BOTTLE, PLASTIC
3	NDC: 13537-445-06	1 in 1 BOX
3	NDC: 13537-445-05	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(13537-445)

Establishment
Name	Address	ID/FEI	Business Operations
Yobel Supply Chain Management S.A. (Peru)		934116930	MANUFACTURE(13537-445)