LBEL EFFET PARFAIT- titanium dioxide, oxybenzone, and octinoxate powder

LBel by

Drug Labeling and Warnings

LBel 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 Ingredient	Purpose
Titanium Dioxide 4.425%	Sunscreen
Oxybenzone 3.0 %	Sunscreen
Octinoxate 4.0%,	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 generously and evently before sun exposure and as needed

Inactive ingredients

Talc, Mica, Boron Nitride, Alumina, Benzimidazole Diamond Amidoethyl Urea Carbamoyl Propyl Polymethylsilsesquioxane, Kaolin, Glyceryl Caprylate, Isononyl Isononanoate, Glycerin, Lycopodium Clavatum Exine, Hydrogen Dimethicone, Lauroyl Lysine, Fragrance, Ceramide 3, Methylparaben, Propylparaben, Imperata Cylindrica Root Extract. May Contain: CI 77491, CI 77492, CI 77499 (Iron Oxides), CI 77891 (Titanium Dioxide).

SPL UNCLASSIFIED SECTION

USA: Dist. by Ventura International Ltd. San Francisco, CA 94111. Made in Colombia.

PRINCIPAL DISPLAY PANEL - 10 g Compact Carton

EFFET PARFAIT

moisturizing compact powder SPF 15

10 g e (.35 oz.)

L'BEL

INGREDIENTS AND APPEARANCE

LBEL   EFFET PARFAIT
titanium dioxide, oxybenzone, and octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-446
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.04425 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.03 g  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
BORON NITRIDE (UNII: 2U4T60A6YD)
ALUMINUM OXIDE (UNII: LMI26O6933)
KAOLIN (UNII: 24H4NWX5CO)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
GLYCERIN (UNII: PDC6A3C0OX)
LAUROYL LYSINE (UNII: 113171Q70B)
CERAMIDE 3 (UNII: 4370DF050B)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-446-02	1 in 1 BOX
1	NDC: 14783-446-01	10 g in 1 CASE
2	NDC: 14783-446-04	1 in 1 BOX
2	NDC: 14783-446-03	7.8 g in 1 CASE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/24/2012

Labeler - Ventura International Ltd (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14783-446)