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LBel

Ventura Corporation LTD

L'BEL EFFET PARFAIT loose extra-fine portable powder SPF 15


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active Ingredient Purpose
Titanium Dioxide 3.5% Sunscreen
Oxybenzone 3.0 % Sunscreen
Octinoxate 3.0% Sunscreen

LBel 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, Zea Mays Starch( Zea Mays (Corn) Starch), Titanium Dioxide, Silica, Benzophenone-3, Calcium Carbonate, Ethylhexyl Methoxycinnamate, Kaolin, Zinc Stearate, Octyldodecanol, Isostearyl Neopentanoate, Glyceryl Caprylate, Methyl Methacrylate Crosspolymer, Magnesium Myristate, Hydrogen Dimethicone, Tocopheryl Acetate, Methylparaben, Propylparaben, Alumina, Microcristallina Cera (Microcrystalline Wax), Petrolatum, Phospholipids, Cholesterol, Candelilla Cera (Euphorbia Cerifera (Candelilla Wax), Cera Alba (Beeswax), Cetearyl Alcohol, Cetearyl Glucoside, Copernicia Cerifera Cera (Copernicia Cerifera (Carnauba) Wax), Polyglyceryl-2 Dipolyhydroxystearate, Glycosphingolipids. May Contain: CI 77499, CI 77492, CI 77491 (Iron Oxides), CI 77891 (Titanium Dioxide).

Dist. by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 12 g Bottle Carton

EFFET
PARFAIT

loose extra-fine portable
powder SPF 15

12 g e (.42 oz.)

L'BEL

LBel

LBel

TITANIUM DIOXIDE, OXYBENZONE, and OCTINOXATE POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-150
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 0.035 g
OXYBENZONE OXYBENZONE 0.03 g
OCTINOXATE OCTINOXATE 0.03 g

Inactive Ingredients

Ingredient Name Strength
talc
STARCH, CORN
SILICON DIOXIDE
CALCIUM CARBONATE
KAOLIN
ZINC STEARATE
OCTYLDODECANOL
ISOSTEARYL NEOPENTANOATE
GLYCERYL CAPRYLATE
MAGNESIUM MYRISTATE
ALPHA-TOCOPHEROL ACETATE
METHYLPARABEN
PROPYLPARABEN
ALUMINUM OXIDE
MICROCRYSTALLINE WAX
petrolatum
CHOLESTEROL
CANDELILLA WAX
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
carnauba wax
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
ferric oxide red

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-150-01 12 in 1 BOTTLE
2 NDC:13537-150-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-01-24


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