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LBel

VENTURA INTERNATIONAL LTD.,

L'BEL SUPRÉMACIE MAINS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredients

Ensulizole (3 %), Octinoxate (7.5%), Oxybenzone (2 %)

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

  • moderate sun protection product.
  • apply smoothly every morning before sun exposure and as needed.
  • apply a small amount of the product to the back of clean, dry hands. Massage softly until completely absorbed.
  • children under 6 months of age: ask a doctor.

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, cyclopentasiloxane, saccharomyces/xylinum/black tea ferment, triethanolamine, glycerin, cyclohexasiloxane, cetyl alcohol, glyceryl stearate, cetearyl alcohol, talc, propyleneglycol, peg-100 stearate, parfum (fragance), diazolidinyl urea, phenyl trimethicone, sodium lactate, acrylates/c10-30 alkylacrilate crosspolymer, ceteareth-20, hydroxyethylcellulose, methylparaben, propylparaben, butylene glycol, hydrolyzed keratin, arctostaphylos uva ursi/leaf extract, panthenol, citrus unshiu peel extract, dimethicone crosspolymer, dimethicone/vinyl dimethicone crosspolymer, ci 77891 (titanium dioxide), tetrasodium edta, dimethiconol, phenoxyethanol, nymphaea coerulea flower extract, ci 19140 (yellow 5), ci 14700 (red 4), butylparaben, ethylparaben, isobutylparaben.

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

PRINCIPAL DISPLAY PANEL - 100 ml Carton

L'BEL

SUPRÉMACIE
MAINS

replenishing treatment
hand cream spf 15

100 ml e (3.3 fl.oz.)

LBel

LBel

Ensulizole, Octinoxate, and Oxybenzone CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:14783-072
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Ensulizole Ensulizole 3 g
OCTINOXATE OCTINOXATE 7.5 g
OXYBENZONE OXYBENZONE 6.2 g

Inactive Ingredients

Ingredient Name Strength
water
C12-15 ALKYL BENZOATE
CYCLOMETHICONE 5
TEA LEAF
TROLAMINE
GLYCERIN
CYCLOMETHICONE 6
CETYL ALCOHOL
GLYCERYL MONOSTEARATE
CETOSTEARYL ALCOHOL
talc
propylene glycol
POLYOXYL 100 STEARATE
DIAZOLIDINYL UREA
PHENYL TRIMETHICONE
sodium lactate
POLYOXYL 20 CETOSTEARYL ETHER
METHYLPARABEN
PROPYLPARABEN
BUTYLENE GLYCOL
arctostaphylos uva-ursi leaf
PANTHENOL
TANGERINE
DIMETHICONE
titanium dioxide
EDETATE SODIUM
PHENOXYETHANOL
FD&C YELLOW NO. 5
FD&C RED NO. 4
BUTYLPARABEN
ETHYLPARABEN
isobutylparaben

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:14783-072-62 100 in 1 JAR
2 NDC:14783-072-61 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

Ensulizole, Octinoxate, and Oxybenzone CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:14783-062
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Ensulizole Ensulizole 0.15 g
OCTINOXATE OCTINOXATE 0.38 g
OXYBENZONE OXYBENZONE 0.31 g

Inactive Ingredients

Ingredient Name Strength
water
C12-15 ALKYL BENZOATE
CYCLOMETHICONE 5
TEA LEAF
TROLAMINE
GLYCERIN
CYCLOMETHICONE 6
CETYL ALCOHOL
GLYCERYL MONOSTEARATE
CETOSTEARYL ALCOHOL
talc
propylene glycol
POLYOXYL 100 STEARATE
DIAZOLIDINYL UREA
PHENYL TRIMETHICONE
sodium lactate
POLYOXYL 20 CETOSTEARYL ETHER
METHYLPARABEN
PROPYLPARABEN
BUTYLENE GLYCOL
arctostaphylos uva-ursi leaf
PANTHENOL
TANGERINE
DIMETHICONE
titanium dioxide
EDETATE SODIUM
PHENOXYETHANOL
FD&C YELLOW NO. 5
FD&C RED NO. 4
BUTYLPARABEN
ETHYLPARABEN
isobutylparaben

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:14783-062-52 5 in 1 JAR
2 NDC:14783-062-51 1 in 1 BOX

Marketing Information

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


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