LBEL LEDERM 35 PLUS JOUR FACIAL AGAINST FIRST SIGNS OF AGING- avobenzone, octisalate, octocrylene, and oxybenzone lotion

LBEL LEDERM 35 plus JOUR Facial against first signs of aging by

Drug Labeling and Warnings

LBEL LEDERM 35 plus JOUR Facial against first signs of aging by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Avobenzone 3%	Sunscreen
Octisalate 5%	Sunscreen
Octocrylene 3%	Sunscreen
Oxybenzone 5%	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

water, c12-15 alkyl benzoate, glyceryl stearate, dimethicone, cyclohexasiloxane, potassium cetyl phosphate, butylene glycol, niacinamide, peg-100 stearate, pentylene glycol, hydrogenated palm glycerides, phenoxyethanol, methyl methacrylate crosspolymer, tocopheryl acetate, xanthan gum, acrylates/c10-30 alkyl acrylate crosspolymer, chlorphenesin, fragrance, acacia senegal gum, sodium hydroxide, disodium edta, hydrolyzed lupine protein, yeast extract, prunus persica (peach) leaf extract, glycerin, ceratonia siliqua (carob) seed extract.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box

FORMULA CREATED BY FRENCH DERMATOLOGISTS
SKIN
EXPERTS

LEDERM

35+ JOUR

facial lotion
against first
signs of aging
day lotion SPF 15
all skin types

50 ml e (1.6 fl.oz.)

INGREDIENTS AND APPEARANCE

LBEL LEDERM 35 PLUS JOUR FACIAL AGAINST FIRST SIGNS OF AGING 
avobenzone, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-995
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 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.05 g  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.03 g  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.05 g  in 1 mL

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)
xanthan gum (UNII: TTV12P4NEE)
carbomer interpolymer type a (allyl sucrose crosslinked) (UNII: 59TL3WG5CO)
chlorphenesin (UNII: I670DAL4SZ)
acacia (UNII: 5C5403N26O)
sodium hydroxide (UNII: 55X04QC32I)
edetate disodium anhydrous (UNII: 8NLQ36F6MM)
yeast, unspecified (UNII: 3NY3SM6B8U)
prunus persica leaf (UNII: VN3501T41P)
glycerin (UNII: PDC6A3C0OX)
carob (UNII: 5MG5Z946UO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-995-02	1 in 1 BOX	10/24/2016
1	NDC: 13537-995-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	10/24/2016

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-995)