LBEL- octinoxate and oxybenzone powder

LBEL by

Drug Labeling and Warnings

LBEL by is a Otc medication manufactured, distributed, or labeled by Ventura International Ltd. (San Francisco, CA), Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Octinoxate 7.5 %	sunscreen
Oxybenzone 2.0%	sunscreen

Uses

• Helps prevent sunburn
• Higher SPF gives more sunburn protection
• Provides moderate 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

isostearyl neopentanoate, mica, c12-15 alkyl benzoate, ethylhexyl palmitate, polymethyl methacrylate, dimethicone/vinyl dimethicone crosspolymer, polyethylene, ozokerite, kaolin, copernicia cerifera cera (copernicia cerifera (carnauba) wax), zea mays starch (zea mays (corn) starch), kojic dipalmitate, phenoxyethanol, dimethicone, octyldodecanol, glyceryl isostearate, isostearyl alcohol, methylparaben, silica, butyrospermum parkii (butyrospermum parkii (shea butter)), cera microcristallina (microcrystalline wax), propylparaben, beta-sitosterol, parfum (fragrance), candelilla cera (euphorbia cerifera (candelilla) wax), trimethylsiloxysilicate, petrolatum, phospholipids, bht, glycyrrhiza glabra root extract (glycyrrhiza glabra (licorice) root extract), butylparaben, ethylparaben, cholesterol, isobutylparaben, cera alba (beeswax), cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, chitosan, glycosphingolipids. May contain: ci 77891 (titanium dioxide), ci 77492 (iron oxides), ci 77491 (iron oxides), ci 77499 (iron oxides).

PRINCIPAL DISPLAY PANEL - 8 g Carton

EFFET
PARFAIT

facial spots clarifying effect compact spf 18

8 g e (.28 oz.)

L'BEL

INGREDIENTS AND APPEARANCE

LBEL   EFFET PARFAIT
octinoxate and oxybenzone powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-240
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CERESIN (UNII: Q1LS2UJO3A)
KAOLIN (UNII: 24H4NWX5CO)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
KOJIC DIPALMITATE (UNII: 13N249RWTM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTYLDODECANOL (UNII: 461N1O614Y)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
METHYLPARABEN (UNII: A2I8C7HI9T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SHEA BUTTER (UNII: K49155WL9Y)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CANDELILLA WAX (UNII: WL0328HX19)
PETROLATUM (UNII: 4T6H12BN9U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
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: 14783-240-02	1 in 1 BOX
1	NDC: 14783-240-01	8 g in 1 CASE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	08/16/2010

Labeler - Ventura International Ltd. (San Francisco, CA) (603192787)

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