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LBel Paris

Ventura International LTD

L'BELPARISREGRESSIONJOUR


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredients

Octinoxate (7.5 %), Octisalate (4 %), Oxybenzone (4 %)

Purpose

Sunscreen

LBel Paris 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 and 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 smoothly every morning before sun exposure and as needed.
  • apply after cleansing and toning on face and neck.
  • children under 6 months of age: ask a doctor.

LBel Paris Other information

  • Moderate sun protection product.
  • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun.

Inactive ingredients

Aqua (water), glycine soja (soybean) protein, c12-15 alkyl benzoate, pisum sativum (pea) extract, cyclohexasiloxane, dimethicone, mannitol, cetearyl alcohol, glyceryl stearate, hdi/ trimethylol hexyllactone crosspolymer, phenoxyethanol, sodium acrylate/ acryloyldimethyltaurate/ dimethylacrylamide crosspolymer, c20-22 alkyl phosphate, hydroxyethyl acrylate/ sodium acryloyldymethyl taurate copolymer, c20-22 alcohols, triethanolamine, isohexadecane, methylparaben, c14-22 alcohols, cetearyl glucoside, hydrolyzed adansonia digitata extract, butylparaben, cyclopentasiloxane, chlorphenesin, propylparaben, xanthan gum, disodium edta, acrylates/c10-30 alkyl acrylate crosspolymer, parfum (fragance), sorbic acid, polysorbate 60, cyclodextrin, c12-20 alkyl glucoside, faex extract (yeast extract), hydrolyzed algin, ethylparaben, chlorella vulgaris extract, maris aqua (sea water), isobutylparaben, silica, disodium succinate, ci42090 (blue 1).

US: Distributed by Ventura International, Ltd. San Francisco, CA 94111

PRINCIPAL DISPLAY PANEL - 50 ml Carton

L'BEL
PARIS

REGRESSION
JOUR

protective complex against
the first signs of age
with spf 15 facial day lotion
normal to combination skin

50 ml e (1.6 fl.oz.)

LBel Paris

LBel Paris

Octinoxate, Octisalate, and Oxybenzone CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:14783-055
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 3.75 g
OCTISALATE OCTISALATE 2 g
OXYBENZONE OXYBENZONE 2 g

Inactive Ingredients

Ingredient Name Strength
water
SOYBEAN
C12-15 ALKYL BENZOATE
snow pea
CYCLOMETHICONE 6
DIMETHICONE
mannitol
CETOSTEARYL ALCOHOL
GLYCERYL MONOSTEARATE
PHENOXYETHANOL
TROLAMINE
Isohexadecane
METHYLPARABEN
BUTYLPARABEN
CYCLOMETHICONE 5
CHLORPHENESIN
PROPYLPARABEN
XANTHAN GUM
EDETATE DISODIUM
sorbic acid
POLYSORBATE 60
yeast
ETHYLPARABEN
isobutylparaben
SILICON DIOXIDE
sodium succinate anhydrous
FD&C BLUE NO. 1

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:14783-055-66 50 in 1 JAR
2 NDC:14783-055-61 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2010-08-15


LBel Paris

Octinoxate, Octisalate, and Oxybenzone CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:14783-045
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.375 g
OCTISALATE OCTISALATE 0.2 g
OXYBENZONE OXYBENZONE 0.2 g

Inactive Ingredients

Ingredient Name Strength
water
SOYBEAN
C12-15 ALKYL BENZOATE
snow pea
CYCLOMETHICONE 6
DIMETHICONE
mannitol
CETOSTEARYL ALCOHOL
GLYCERYL MONOSTEARATE
PHENOXYETHANOL
TROLAMINE
Isohexadecane
METHYLPARABEN
BUTYLPARABEN
CYCLOMETHICONE 5
CHLORPHENESIN
PROPYLPARABEN
XANTHAN GUM
EDETATE DISODIUM
sorbic acid
POLYSORBATE 60
yeast
ETHYLPARABEN
isobutylparaben
SILICON DIOXIDE
sodium succinate anhydrous
FD&C BLUE NO. 1

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:14783-045-52 5 in 1 JAR
2 NDC:14783-045-51 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2010-08-15


LBel Paris

Octinoxate, Octisalate, and Oxybenzone CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:14783-035
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.75 g
OCTISALATE OCTISALATE 0.04 g
OXYBENZONE OXYBENZONE 2 g

Inactive Ingredients

Ingredient Name Strength
water
SOYBEAN
C12-15 ALKYL BENZOATE
snow pea
CYCLOMETHICONE 6
DIMETHICONE
mannitol
CETOSTEARYL ALCOHOL
GLYCERYL MONOSTEARATE
PHENOXYETHANOL
TROLAMINE
Isohexadecane
METHYLPARABEN
BUTYLPARABEN
CYCLOMETHICONE 5
CHLORPHENESIN
PROPYLPARABEN
XANTHAN GUM
EDETATE DISODIUM
sorbic acid
POLYSORBATE 60
yeast
ETHYLPARABEN
isobutylparaben
SILICON DIOXIDE
sodium succinate anhydrous
FD&C BLUE NO. 1

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:14783-035-42 1 in 1 JAR
2 NDC:14783-035-41 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2010-08-15


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