LBEL description, usages, side effects, indications, overdosage, supplying and lots more!

LBEL

Ventura International Ltd.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
L'BELPROTÈGE EXPERT moisturizing face protector lotion SPF 40

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredients

Ensulizole 3%,
Octinoxate 7.5%,
Octisalate 5%,
Oxybenzone 6%,
Titanium dioxide 3.9%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.
  • Provides high protection against sunburn
  • Retains SPF after 40 minutes of activity in the water

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 liberally before sun exposure and as needed

Other information

  • Sun alert: Limiting sun exposure, waring 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), dicaprylyl carbonate, c12-15 alkyl benzoate, vp/eicosene copolymer, triethanolamine, methyl methacrylate crosspolymer, dimethicone, cyclopentasiloxane, cetearyl alcohol, sorbitan stearate, glyceryl stearate, potassium cetyl phosphate, tocopheryl acetate, cyclohexasiloxane, silica, trimethylsiloxysilicate, phenoxyethanol, methicone, ceteareth-20, methylparaben, xanthan gum, mannitol, parfum (fragrance), propylparaben, butylparaben, ethylparaben, isobutylparaben, arginine, cyclodextrin, dextrin, faex extract (yeast extract), histidine hydrochloride (histidine hci), pisum sativum extract (pisum sativum (pea) extract), acetyltyrosine, disodium succinate, khaya senegalensis bark extract, nicotinamide adenine dinucleotide, pyridoxine hci, aspartic acid.

PRINCIPAL DISPLAY PANEL - 50 ml Carton

L'BEL

PROTÈGE
EXPERT

moisturizing face
protector lotion
SPF 40

loción protectora
hidratante para rostro
FPS 40

WATER RESISTANT
RESISTENTE AL AGUA

50 ml e (1.7 fl.oz.)

UVB SPF
40

High Protection

UVA
PA + +

PRINCIPAL DISPLAY PANEL - 50 ml Carton

LBEL

Ensulizole, Octinoxate, Octisalate, Oxybenzone, and Titanium dioxide LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:14783-304
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Ensulizole Ensulizole .03 g
OCTINOXATE OCTINOXATE .075 g
OCTISALATE OCTISALATE .05 g
OXYBENZONE OXYBENZONE .06 g
titanium dioxide .039 g

Inactive Ingredients

Ingredient Name Strength
water
DICAPRYLYL CARBONATE
ALKYL (C12-15) BENZOATE
DIMETHICONE
CYCLOMETHICONE 5
CETOSTEARYL ALCOHOL
SORBITAN MONOSTEARATE
GLYCERYL MONOSTEARATE
potassium cetyl phosphate
CYCLOMETHICONE 6
SILICON DIOXIDE
PHENOXYETHANOL
POLYOXYL 20 CETOSTEARYL ETHER
METHYLPARABEN
XANTHAN GUM
mannitol
PROPYLPARABEN
BUTYLPARABEN
ETHYLPARABEN
isobutylparaben
ARGININE
yeast
HISTIDINE MONOHYDROCHLORIDE
PEA
sodium succinate anhydrous
khaya senegalensis bark
NADIDE
PYRIDOXINE HYDROCHLORIDE
ASPARTIC ACID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:14783-304-01 50 in 1 BOTTLE
2 NDC:14783-304-03 5 in 1 BOTTLE
3 NDC:14783-304-05 1 in 1 PACKET

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-04-19


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