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LBel

VENTURA INTERNATIONAL LTD.,

L'BEL CLARIFIQUE DERMO RADIANCE MAINS SPF 15


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredients

Octinoxate (7.5 %), Octisalate (5 %), Oxybenzone (6 %)

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 twice a day before sun exposure and as needed.
  • Reapply as needed or after towel drying, swimming or sweating.
  • Moderate sun protection product.
  • 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), cyclohexasiloxane, c12-15 alkyl benzoate, cetearyl alcohol, ethylhexyl stearate, cyclopentasiloxane, citrus unshui peel extract, propylene glycol, triethanolamine, glycerin, dicetyl phosphate, ceteth-10 phosphate, sodium lactate, tocopheryl acetate, phenoxyethanol, diazolidinyl urea, parfum (fragance), glycolic acid, methylparaben, sucrose, urea, sodium citrate, propylparaben, malic acid, tartaric acid, camellia sinensis leaf extract.

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

PRINCIPAL DISPLAY PANEL - 100 g Tube Carton

L'BEL

CLARIFIQUE
DERMO RADIANCE
MAINS SPF 15

clarifying and illuminating
treatment hand cream spf 15

100 g e (3.5 oz.)

LBel

LBel

Octinoxate, Octisalate, and Oxybenzone CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:14783-077
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 7.5 g
OCTISALATE OCTISALATE 5 g
OXYBENZONE OXYBENZONE 6 g

Inactive Ingredients

Ingredient Name Strength
water
CYCLOMETHICONE 6
C12-15 ALKYL BENZOATE
CETOSTEARYL ALCOHOL
CYCLOMETHICONE 5
TANGERINE
propylene glycol
TROLAMINE
GLYCERIN
DIHEXADECYL PHOSPHATE
PHOSPHATE ION
sodium lactate
PHENOXYETHANOL
DIAZOLIDINYL UREA
GLYCOLIC ACID
METHYLPARABEN
SUCROSE
UREA
SODIUM CITRATE
PROPYLPARABEN
Malic Acid
tartaric acid
GREEN TEA LEAF

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:14783-077-62 100 in 1 TUBE
2 NDC:14783-077-61 1 in 1 BOX

Marketing Information

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


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