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LBEL

Ventura International LTD

L'BEL PARIS HYDRA CALME


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredients

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

Purpose

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 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.
  • use in the morning after cleansing and toning. Apply small amounts using the fingertips and spreading with upward, circular movements. Rub gently until absorbed completely.
  • children under 6 months of age: ask a doctor.
  • moderate sun protection product.

LBEL Other information

  • 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), c12-15 alkyl benzoate, pisum sativum (pea) extract, cyclohexasiloxane, dimethicone, butylene glycol, cetearyl alcohol, erythritol, hdi/trimethylol hexyllactone crosspolymer, phenoxyethanol, sodium acrylate/acryloyldimethyltaurate/dimethylacrylamide crosspolymer, c20-22 alkyl phosphate, propyleneglycol, hydroxyethyl acrylate/sodium acryloyldymethyl taurate copolymer, glyceryl stearate, c20-22 alcohols, triethanolamine, isohexadecane, methylparaben, parfum (fragance), c14-22 alcohols, cetearyl glucoside, butylparaben, cyclopentasiloxane, chlorphenesin, propylparaben, xanthan gum, disodium edta, acrylates/c10-30 alkylacrilate crosspolymer, sorbic acid, polysorbate 60, c12-20 alkyl glucoside, glycerin, hydrolized algin, ethylparaben, chlorella vulgaris extract, maris aqua (sea water), isobutylparaben, silica, homarine hcl, rubus chamaemorus fruit extract.

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

PRINCIPAL DISPLAY PANEL - 30 ml Carton

L'BEL
PARIS

HYDRA CALME

SPF 15

intensive moisturizing facial
lotion SPF 15

30 ml e (1 fl.oz.)

LBEL

LBEL

Octinoxate, Octisalate, and Oxybenzone LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-088
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 2.25 mg
OCTISALATE OCTISALATE 1.2 mg
OXYBENZONE OXYBENZONE 1.2 mg

Inactive Ingredients

Ingredient Name Strength
water
C12-15 ALKYL BENZOATE
snow pea
CYCLOMETHICONE 6
DIMETHICONE
BUTYLENE GLYCOL
CETOSTEARYL ALCOHOL
ERYTHRITOL
PHENOXYETHANOL
propylene glycol
GLYCERYL MONOSTEARATE
TROLAMINE
Isohexadecane
METHYLPARABEN
BUTYLPARABEN
CYCLOMETHICONE 5
CHLORPHENESIN
PROPYLPARABEN
XANTHAN GUM
EDETATE DISODIUM
sorbic acid
POLYSORBATE 60
GLYCERIN
ETHYLPARABEN
isobutylparaben
SILICON DIOXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-088-62 30 in 1 BOTTLE
2 NDC:13537-088-63 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

Octinoxate, Octisalate, and Oxybenzone LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-089
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.075 mg
OCTISALATE OCTISALATE 0.04 mg
OXYBENZONE OXYBENZONE 0.04 mg

Inactive Ingredients

Ingredient Name Strength
water
C12-15 ALKYL BENZOATE
snow pea
CYCLOMETHICONE 6
DIMETHICONE
BUTYLENE GLYCOL
CETOSTEARYL ALCOHOL
ERYTHRITOL
PHENOXYETHANOL
propylene glycol
GLYCERYL MONOSTEARATE
TROLAMINE
Isohexadecane
METHYLPARABEN
BUTYLPARABEN
CYCLOMETHICONE 5
CHLORPHENESIN
PROPYLPARABEN
XANTHAN GUM
EDETATE DISODIUM
sorbic acid
POLYSORBATE 60
GLYCERIN
ETHYLPARABEN
isobutylparaben
SILICON DIOXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-089-52 1 in 1 JAR
2 NDC:13537-089-53 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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