LBEL LEDERM 45PLUS JOUR SPF 15 FACIAL TREATMENT AGAINST NOTICEABLE SIGNS OF AGING DAY - NORMAL TO DRY SKIN- avobenzone, octisalate, octocrylene, and oxybenzone cream

LBEL LEDERM 45plus Jour by

Drug Labeling and Warnings

LBEL LEDERM 45plus 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, CYCLOHEXASILOXANE, GLYCERIN, DIMETHICONE, POTASSIUM CETYL PHOSPHATE, ALBIZIA JULIBRISSIN BARK EXTRACT, BUTYLENE GLYCOL, GLYCERYL STEARATE, PENTYLENE GLYCOL, HYDROGENATED PALM GLYCERIDES, PHENOXYETHANOL, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, XANTHAN GUM, C20-22 ALKYL PHOSPHATE, ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER, PARFUM (FRAGRANCE), C20-22 ALCOHOLS, CHLORPHENESIN, HYDROLYZED CERATONIA SILIQUA SEED EXTRACT, ACACIA SENEGAL GUM, SODIUM HYDROXIDE, DISODIUM EDTA, OLIVE OIL AMINOPROPANEDIOL ESTERS, RASPBERRY SEED OIL/TOCOPHERYL SUCCINATE AMINOPROPANEDIOL ESTERS, HYDROXYPROPYL CYCLODEXTRIN, SILICA, 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 FRENCH DERMATOLOGISTS
SKIN EXPERTS

45+ JOUR

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

50 g e (1.7 oz.)

INGREDIENTS AND APPEARANCE

LBEL LEDERM 45PLUS JOUR   SPF 15 FACIAL TREATMENT AGAINST NOTICEABLE 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: 13537-447
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)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)
C20-22 ALCOHOLS (UNII: O4M0347C6A)
CHLORPHENESIN (UNII: I670DAL4SZ)
ACACIA (UNII: 5C5403N26O)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-447-01	1 g in 1 PACKET
2	NDC: 13537-447-04	1 in 1 BOX
2	NDC: 13537-447-03	5 g in 1 BOTTLE, PLASTIC
3	NDC: 13537-447-06	1 in 1 BOX
3	NDC: 13537-447-05	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(13537-447)

Establishment
Name	Address	ID/FEI	Business Operations
Yobel Supply Chain Management S.A. (Peru)		934116930	MANUFACTURE(13537-447)