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LBel

Ventura Corporation Ltd.

L'BEL PROTÈGE EXPERT sunscreen for eyes contour and lips SPF 30


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredients

Octinoxate 7.5%, Octisalate 4%, Octocrylene 10%, Oxybenzone 6%, Titanium dioxide 1%

Purpose

sunscreen

LBel Uses

  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • Provides high protection against sunburn
  • Retains SPF after 40 minutes of activity in the water.

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

LBel Other information

  • Sun alert: Limiting sun exposure, waring protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

Ozokerite, hydrogenated vegetable oil, petrolatum, butyrosperum parkii (butyrospermum parkii (shea butter)), ricinus communis seed oil (ricinus communis (castor ) seed oil), c12-15 alkyl benzoate, isopropyl lanolate, paraffin, copernicia cerifera cera (copernicia cerifera (carnauba ) wax), isopropyl myristate, bht, propylparaben, tocopheryl acetate, octyldodecanol, cera microcristallina (microcrystalline wax), bha, phospholipids, cholesterol, cera alba (beeswax), cetearyl alcohol, cetearyl glucoside, euphorbia cerifera (candelilla) wax, polyglyceryl-2 dipolyhydroxystearate, glycosphingolipids

US: Dist. by Ventura International Ltd, San Francisco, CA 94111.
P.R.: Dist. by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 5 g Bottle Carton

L'BEL

PROTÈGE
EXPERT

sunscreen for eyes
contour and lips
SPF 30

WATER RESISTANT

5 g e (.17 oz.)

UVB SPF
30

Moderate
Protection
UVA
PA ++

LBel

LBel

Octinoxate, Octisalate, Octocrylene, Oxybenzone, and Titanium dioxide CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-028
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.075 g
OCTISALATE OCTISALATE 0.04 g
OCTOCRYLENE Octocrylene 0.1 g
OXYBENZONE OXYBENZONE 0.06 g
titanium dioxide 0.01 g

Inactive Ingredients

Ingredient Name Strength
petrolatum
SHEA BUTTER
castor oil
ALKYL (C12-15) BENZOATE
PARAFFIN
carnauba wax
ISOPROPYL MYRISTATE
BUTYLATED HYDROXYTOLUENE
PROPYLPARABEN
OCTYLDODECANOL
MICROCRYSTALLINE WAX
BUTYLATED HYDROXYANISOLE
CHOLESTEROL
YELLOW WAX
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
CANDELILLA WAX

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-028-01 5 in 1 BOTTLE
2 NDC:13537-028-02 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-08-10


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