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LBel

VENTURA INTERNATIONAL LTD.,

L'BELSUPRÉMACIE TEINT


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredients

Octinoxate (4.5 %)

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 smootly every morning before sun exposure and as needed.
  • 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), cyclopentasiloxane, butylene glycol, cyclohexasiloxane, phenyl trimethicone, polyglyceryl-4 isostearate, cetyl peg/ppg-10/1 dimethicone, polydodecanamideaminium triazadiphenylethenesulfonate, hexyl laurate, mannitol, glycerin, peg/ppg-18/18 dimethicone, glycine soja (soybean) protein, ethylene/acrylic acid copolymer, sodium chloride, disteardimonium hectorite, dimethicone, propylene glycol, dimethicone crosspolymer, dimethicone/vinyl dimethicone crosspolymer, diazolidinyl urea, hydrolyzed keratin, dimethiconol, sucrose, methylparaben, serine, parfum (fragance), methicone, arginine, cyclodextrin, polyvinylalcohol crosspolymer, pca, bht, macrocystis pyrifera extract, faex extract (yeast extract), alanine, propylparaben, hydrolyzed wheat protein, pvp, carbomer, polysorbate 20, disodium succinate, palmitoyl pentapeptide-4, threonine, mourera fluviatilis extract. May contain: ci 77891(titanium dioxide), ci 77491, ci 77492, ci 77499 (iron oxides).

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

PRINCIPAL DISPLAY PANEL - 30 g Carton

L'BEL

SUPRÉMACIE TEINT

replenhising foundation spf 14

30 g e (1 oz.)

LBel

LBel

Octinoxate CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:14783-085
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 1.35 g

Inactive Ingredients

Ingredient Name Strength
water
CYCLOMETHICONE 5
BUTYLENE GLYCOL
CYCLOMETHICONE 6
PHENYL TRIMETHICONE
POLYGLYCERYL-4 ISOSTEARATE
DIMETHICONE
HEXYL LAURATE
mannitol
GLYCERIN
glycine
SODIUM CHLORIDE
HECTORITE
propylene glycol
DIAZOLIDINYL UREA
SUCROSE
METHYLPARABEN
SERINE
ARGININE
BUTYLATED HYDROXYTOLUENE
yeast
ALANINE
PROPYLPARABEN
WHEAT
POLYSORBATE 20
sodium succinate anhydrous
THREONINE
titanium dioxide
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:14783-085-64 30 in 1 JAR
2 NDC:14783-085-63 1 in 1 BOX

Marketing Information

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


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