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'BEL PROTEGE EXPERT moisturizing body protector lotion SPF 15

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredients

Octinoxate 7.5%,
Octivsalate 5%,
Oxybenzone 6%,
Titanium dioxide 2.34%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • Provides moderate 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, methyl methacrylate crosspolymer, cyclopentasiloxane, dimethicone, cetearyl alcohol, sorbitan stearate, cyclohexasiloxane, glyceryl stearate, potassium cetyl phosphate, tocopheryl acetate, trimethylsiloxysilicate, phenoxyethanol, silica, 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), acetyl tyrosine, disodium succinate, khaya senegalensis bark extract, nicotinamide adenine dinucleotide, pyridoxine hci, aspartic acid

PRINCIPAL DISPLAY PANEL - 180 ml Bottle Carton

L'BEL

PROTÈGE
EXPERT

moisturizing body
protector lotion
SPF 15

WATER RESISTANT

180 ml e (6.3 fl.oz.)

UVB SPF
15
Moderate
Protection

UVA
PA ++

PRINCIPAL DISPLAY PANEL - 180 ml Bottle Carton

LBEL

Octinoxate, Octisalate, Oxybenzone, and Titanium dioxide LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:14783-301
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE .075 g
OCTISALATE OCTISALATE .05 g
OXYBENZONE OXYBENZONE .06 g
titanium dioxide .0234 g

Inactive Ingredients

Ingredient Name Strength
water
DICAPRYLYL CARBONATE
ALKYL (C12-15) BENZOATE
TROLAMINE
CYCLOMETHICONE 5
DIMETHICONE
CETOSTEARYL ALCOHOL
SORBITAN MONOSTEARATE
CYCLOMETHICONE 6
GLYCERYL MONOSTEARATE
potassium cetyl phosphate
PHENOXYETHANOL
SILICON DIOXIDE
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:14783-301-01 180 in 1 BOTTLE
2 NDC:14783-301-03 10 in 1 TUBE
3 NDC:14783-301-05 5 in 1 TUBE
4 NDC:14783-301-06 1 in 1 BOX

Marketing Information

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


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