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LBEL

Ventura Corporation Ltd. (San Juan, P.R)

L'BEL HYDRA CALME


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active Ingredient Purpose
Octinoxate 7.5% Sunscreen
Octisalate 4.0 % Sunscreen
Oxybenzone 4.0%, 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 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 sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

aqua (water), c12-15 alkyl benzoate, pisum sativum extract (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, glyceryl stearate, hydroxyethyl acrylate/ sodium acryloyldimethyl taurate copolymer, propylene glycol, c20-22 alcohols, triethanolamine, isohexadecane, methylparaben, parfum (fragrance), c14-22 alcohols, cetearyl glucoside, butylparaben, cyclopentasiloxane, chlorphenesin, xanthan gum, propylparaben, acrylates/ c10-30 alkyl acrylate crosspolymer, disodium edta, sorbic acid, polysorbate 60, c12-20 alkyl glucoside, glycerin, hydrolyzed algin, ethylparaben, chlorella vulgaris extract, maris aqua (sea water), isobutylparaben, silica, homarine hcl, rubus chamaemorus fruit extract

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

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

L'BEL

HYDRA CALME

SPF15
Intensive moisturizing
face lotion with SPF 15

50 ml e (1.6 fl.oz.)

LBEL

LBEL

Octinoxate, Octisalate, and Oxybenzone LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-031
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
OXYBENZONE OXYBENZONE 0.04 g

Inactive Ingredients

Ingredient Name Strength
water
ALKYL (C12-15) BENZOATE
PEA
CYCLOMETHICONE 6
DIMETHICONE
BUTYLENE GLYCOL
CETOSTEARYL ALCOHOL
ERYTHRITOL
PHENOXYETHANOL
C20-22 ALKYL PHOSPHATE
GLYCERYL MONOSTEARATE
propylene glycol
C20-22 ALCOHOLS
TROLAMINE
Isohexadecane
METHYLPARABEN
c14-22 alcohols
CETEARYL GLUCOSIDE
BUTYLPARABEN
CYCLOMETHICONE 5
CHLORPHENESIN
XANTHAN GUM
PROPYLPARABEN
EDETATE DISODIUM
sorbic acid
POLYSORBATE 60
C12-20 ALKYL GLUCOSIDE
GLYCERIN
ETHYLPARABEN
CHLORELLA VULGARIS
isobutylparaben
SILICON DIOXIDE
rubus chamaemorus fruit

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-031-01 50 in 1 TUBE
2 NDC:13537-031-03 5 in 1 TUBE
3 NDC:13537-031-05 1 in 1 PACKET

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-08-29


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