LBel by Ventura International LTD / Bel Star, S.A. LBEL- zinc oxide lotion

LBel by

Drug Labeling and Warnings

LBel by is a Otc medication manufactured, distributed, or labeled by Ventura International LTD, Bel Star, S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Zinc oxide 1.6 %

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.

Inactive ingredients

aqua (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).

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box

EFFET
PARFAIT

maximum comfort
and long-lasting
foundation
spf 10

30 ml e (1 fl.oz.)

L'BEL

INGREDIENTS AND APPEARANCE

LBEL   EFFET PARFIT
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-250
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z)	Zinc oxide	0.48 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone (UNII: NMQ347994Z)
dimethicone (UNII: 92RU3N3Y1O)
cyclomethicone 6 (UNII: XHK3U310BA)
sodium chloride (UNII: 451W47IQ8X)
glycerin (UNII: PDC6A3C0OX)
oleth-5 (UNII: 1GH33785AY)
phenyl trimethicone (UNII: DR0K5NOJ4R)
propylene glycol (UNII: 6DC9Q167V3)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
phenoxyethanol (UNII: HIE492ZZ3T)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
silicon dioxide (UNII: ETJ7Z6XBU4)
isobutylparaben (UNII: 0QQJ25X58G)
Mica (UNII: V8A1AW0880)
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: 13537-250-62	1 in 1 BOX
1	NDC: 13537-250-61	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/15/2010

Labeler - Ventura International LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star, S.A.		880160197	MANUFACTURE