LBEL- titanium dioxide, oxybenzone, zinc oxide, and octinoxate powder

LBEL by

Drug Labeling and Warnings

LBEL by is a Otc medication manufactured, distributed, or labeled by Ventura International, Limited, BelStar, S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient	Purpose
Titanium Dioxide 6.0%	Sunscreen
Oxybenzone 5.0 %	Sunscreen
Zinc Oxide 4.9%,	Sunscreen
Octinoxate 3.5%,	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 generously and evently 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

Mica, Boron Nitride, Zea Mays Starch( zea mays (corn) starch), Zinc Stearate, Silica, Isononyl Isononanoate, Magnesium Myristate, Simmondsia Chinensis seed oil(simmondsia chinensis (jojoba) seed oil), Glyceryl Caprylate, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Tocopheryl Acetate, Triethoxycaprylylsilane, Rhodiola Rosea Root Extract, Carnosine, Alanyl Glutamine. May contain: Iron Oxides, Titanium Dioxide.

SPL UNCLASSIFIED SECTION

USA: Dist. by Ventura International Ltd. San Francisco, CA 94111. Made in Colombia. PUERTO RICO: Dist. by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926. Made in Colombia.

PRINCIPAL DISPLAY PANEL - 10 g Container Carton

EFFET PARFAIT
MINÉRAL

natural skin effect powder SPF 20

10 g e (.35 oz.)

L'BEL

INGREDIENTS AND APPEARANCE

LBEL   EFFET PARFAIT MINERAL
titanium dioxide, oxybenzone, zinc oxide, and octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.06 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.05 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.049 g  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.035 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
STARCH, CORN (UNII: O8232NY3SJ)
ZINC STEARATE (UNII: H92E6QA4FV)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
JOJOBA OIL (UNII: 724GKU717M)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CARNOSINE (UNII: 8HO6PVN24W)
ALANYL-GLUTAMINE (UNII: U5JDO2770Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-013-11	1 in 1 CARTON
1	NDC: 14783-013-10	10 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/15/2010

Labeler - Ventura International, Limited (603192787)

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