LBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, octisalate, octocrylene, and oxybenzone lotion

LBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

LBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 by is a Otc medication manufactured, distributed, or labeled by Ventura International 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 3.0%	Sunscreen
OCTISALATE 5.0 %	Sunscreen
OCTOCRYLENE 3.0 %	Sunscreen
OXYBENZONE 5.0 %	Sunscreen

Uses

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

• 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.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply at least every 2 hours
• Children under 6 months of age: Ask a doctor
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m.–2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses.

Other information

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

Inactive ingredients

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, 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

USA: Dist. by Ventura International Ltd. DBA Belcorp USA,
San Francisco, CA 94111.

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Box

FORMULATED BY FRENCH DERMATOLOGISTS
SKIN
EXPERTS

LEDERM

DAY LOTION

SUNSCREEN
BROAD SPECTRUM
SPF 15

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

50 ml e (1.6 fl.oz.)

INGREDIENTS AND APPEARANCE

LBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 
avobenzone, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-804
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)
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)
hexamethylene diisocyanate/trimethylol hexyllactone crosspolymer (UNII: WB5K9Y35Y9)
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)
palmitoyl lysyldioxymethionyllysine (UNII: T7A529FB8O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-804-02	1 in 1 BOX
1	NDC: 14783-804-01	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	06/22/2015

Labeler - Ventura International LTD (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14783-804)