LBEL EFFET PARFAIT MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10- zinc oxide lotion

LBEL by

Drug Labeling and Warnings

LBEL by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation Ltd., Belstar (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Zinc oxide 1.57 %

Purpose

sunscreen

Uses

• Helps prevent sunburn
• Higher SPF gives more sunburn protection
• Provides minimal protection against sunburn

Warnings

For external use only

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally before sun exposure and as needed

Other information

• Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.
• Apply to the forehead , nose, chin and both cheeks. Blend with circilar motion and spread softly without stretching the skin.

Inactive ingredients

water, cyclopentasiloxane, cyclomethicone, dimethicone, polymethyl methacrylate, peg/ppg-18/18 dimethicone, cyclohexasiloxane, methyl methacrylate crosspolymer, sodium chloride, bis-hydroxyethoxypropyl dimethicone, bis-peg 18 methyl ether dimethyl silane, peg/ppg-19/19 dimethicone, glycerin, oleth-5, phenyl trimethicone, hydrolyzed soy protein, propylene glycol, CI 77163 (bismuth oxychloride), silica silylate, CI 77019 (mica), trimethyilsiloxysilicate, methylparaben, triethoxycaprylylsilane, propylparaben, tocopheryl acetate, phenoxyethanol, parfum (fragrance), butylparaben, ethylparaben, silica, isobutylparaben. May contain: ci 77891 (titanium dioxide), CI 77492 (iron oxides), CI 77491 (iron oxides), CI 77499(iron oxides).

SPL UNCLASSIFIED SECTION

PUERTO RICO: Distributed by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926. Made in Columbia

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

EFFET
PARFAIT

maxium comfort
and long-lasting
foundation
SPF 10

30 ml e (1 fl.oz.)

L'BEL

INGREDIENTS AND APPEARANCE

LBEL   EFFET PARFAIT MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-428
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0157 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
GLYCERIN (UNII: PDC6A3C0OX)
OLETH-5 (UNII: 1GH33785AY)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MICA (UNII: V8A1AW0880)
METHYLPARABEN (UNII: A2I8C7HI9T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-428-02	1 in 1 BOX
1	NDC: 13537-428-01	30 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/10/2012

Labeler - Ventura Corporation Ltd. (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Belstar (Colombia)		880160197	MANUFACTURE(13537-428)