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

LBel Paris

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 PARIS REGRESSION JOUR

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredients

Avobenzone (2 %), Ensulizole (1 %), Octinoxate (7.5 %), Oxybenzone (2 %)

Purpose

Sunscreen

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 every morning before sun exposure and as needed.
  • apply after cleansing and toning on face and neck.
  • children under 6 months of age: ask a doctor.

Other information

  • Moderate sun protection product.
  • 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), glycine soja (soybean) protein, propylene glycol, cyclopentasiloxane, cetyl alcohol, c12-15 alkyl benzoate, pisum sativum (pea) extract, cyclohexasiloxane, triethanolamine, glyceryl stearate, mannitol, corn starch modified, polyacrylamide, phenoxyethanol, stearic acid, hydrolyzed adansonia digitata extract, peg-75 stearate, methylparaben, c13- 14 isoparaffin, propylparaben, xanthan gum, parfum (fragance), ceteth-20, steareth-20, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, acrylates/c10-30 alkyl acrylate crosspolymer, disodium edta, laureth-7, cyclodextrin, dimethicone crosspolymer, faex extract (yeast extract), dimethicone, hydrolyzed algin, butylparaben, ethylparaben, chlorella vulgaris extract, maris aqua (sea water), isobutylparaben, laureth-23, laureth-4, disodium succinate, ci42090 (blue 1).

PRINCIPAL DISPLAY PANEL - 50 g Jar Carton

L'BEL
PARIS

REGRESSION JOUR

protective complex against the first signs of age with
spf 15 facial day cream normal to dry skin

50 g e (1.7 oz.)

PRINCIPAL DISPLAY PANEL - 50 g Jar Carton

PRINCIPAL DISPLAY PANEL - 5 g Jar Carton

L'BEL
PARIS

REGRESSION JOUR

protective complex against the first signs
of age with spf 15 facial day cream
normal to dry skin

5 g e (.17 oz.)

PRINCIPAL DISPLAY PANEL - 5 g Jar Carton

LBel Paris

Avobenzone, Ensulizole, Octinoxate, and Oxybenzone CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:14783-049
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 1 g
Ensulizole Ensulizole 0.5 g
OCTINOXATE OCTINOXATE 3.75 g
OXYBENZONE OXYBENZONE 1 g

Inactive Ingredients

Ingredient Name Strength
water
SOYBEAN
propylene glycol
CYCLOMETHICONE 5
CETYL ALCOHOL
C12-15 ALKYL BENZOATE
snow pea
CYCLOMETHICONE 6
TROLAMINE
GLYCERYL MONOSTEARATE
mannitol
PHENOXYETHANOL
STEARIC ACID
METHYLPARABEN
C13-14 ISOPARAFFIN
PROPYLPARABEN
XANTHAN GUM
CETETH-20
Steareth-20
EDETATE DISODIUM
LAURETH-7
yeast
DIMETHICONE
BUTYLPARABEN
ETHYLPARABEN
isobutylparaben
laureth-23
laureth-4
sodium succinate anhydrous

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:14783-049-62 50 in 1 JAR
2 NDC:14783-049-61 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 Paris

Avobenzone, Ensulizole, Octinoxate, and Oxybenzone CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:14783-039
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 0.1 g
Ensulizole Ensulizole 0.05 g
OCTINOXATE OCTINOXATE 0.375 g
OXYBENZONE OXYBENZONE 0.1 g

Inactive Ingredients

Ingredient Name Strength
water
SOYBEAN
propylene glycol
CYCLOMETHICONE 5
CETYL ALCOHOL
C12-15 ALKYL BENZOATE
snow pea
CYCLOMETHICONE 6
TROLAMINE
GLYCERYL MONOSTEARATE
mannitol
PHENOXYETHANOL
STEARIC ACID
METHYLPARABEN
C13-14 ISOPARAFFIN
PROPYLPARABEN
XANTHAN GUM
CETETH-20
Steareth-20
EDETATE DISODIUM
LAURETH-7
yeast
DIMETHICONE
BUTYLPARABEN
ETHYLPARABEN
isobutylparaben
laureth-23
laureth-4
sodium succinate anhydrous

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:14783-039-52 5 in 1 JAR
2 NDC:14783-039-51 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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