L'bel

L'bel
SPL v1
SPL
SPL Set ID 132ef4d4-8554-4e37-89a9-c9b5db96cc13
Route
TOPICAL
Published
Effective Date 2010-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.75 g) Octisalate (2 g) Oxybenzone (0.375 g)
Inactive Ingredients
Water Soybean C12-15 Alkyl Benzoate Snow Pea Cyclomethicone 6 Dimethicone Mannitol Cetostearyl Alcohol Glyceryl Monostearate Phenoxyethanol Trolamine Isohexadecane Methylparaben Butylparaben Cyclomethicone 5 Chlorphenesin Propylparaben Xanthan Gum Edetate Disodium Sorbic Acid Polysorbate 60 Yeast Ethylparaben Isobutylparaben Silicon Dioxide Sodium Succinate Anhydrous Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-08-15

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

Uses
  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • provides moderate protection against sunburn
Section 42229-5

Drug Facts

Section 50565-1
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9

Stop use and ask a doctor if

  • rash and irritation develops and lasts.
Section 50567-7

When using this product

  • keep out of eyes. Rinse with water to remove.
Warnings
  • For external use only.
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.
Active Ingredients

Octinoxate (7.5 %), Octisalate (4 %), Oxybenzone (4 %)

Inactive Ingredients

Aqua (water), glycine soja (soybean) protein, c12-15 alkyl benzoate, pisum sativum (pea) extract, cyclohexasiloxane, dimethicone, mannitol, cetearyl alcohol, glyceryl stearate, hdi/ trimethylol hexyllactone crosspolymer, phenoxyethanol, sodium acrylate/ acryloyldimethyltaurate/ dimethylacrylamide crosspolymer, c20-22 alkyl phosphate, hydroxyethyl acrylate/ sodium acryloyldymethyl taurate copolymer, c20-22 alcohols, triethanolamine, isohexadecane, methylparaben, c14-22 alcohols, cetearyl glucoside, hydrolyzed adansonia digitata extract, butylparaben, cyclopentasiloxane, chlorphenesin, propylparaben, xanthan gum, disodium edta, acrylates/c10-30 alkyl acrylate crosspolymer, parfum (fragance), sorbic acid, polysorbate 60, cyclodextrin, c12-20 alkyl glucoside, faex extract (yeast extract), hydrolyzed algin, ethylparaben, chlorella vulgaris extract, maris aqua (sea water), isobutylparaben, silica, disodium succinate, ci42090 (blue 1).

Principal Display Panel 50 Ml Carton

L'BEL

PARIS

REGRESSION

JOUR

protective complex against

the first signs of age

with spf 15 facial day lotion

normal to combination skin

50 ml e (1.6 fl.oz.)


Structured Label Content

Uses
  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • provides moderate protection against sunburn
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • rash and irritation develops and lasts.
Section 50567-7 (50567-7)

When using this product

  • keep out of eyes. Rinse with water to remove.
Purpose

Sunscreen

Warnings
  • For external use only.
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 (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.
Active Ingredients

Octinoxate (7.5 %), Octisalate (4 %), Oxybenzone (4 %)

Inactive Ingredients (Inactive ingredients)

Aqua (water), glycine soja (soybean) protein, c12-15 alkyl benzoate, pisum sativum (pea) extract, cyclohexasiloxane, dimethicone, mannitol, cetearyl alcohol, glyceryl stearate, hdi/ trimethylol hexyllactone crosspolymer, phenoxyethanol, sodium acrylate/ acryloyldimethyltaurate/ dimethylacrylamide crosspolymer, c20-22 alkyl phosphate, hydroxyethyl acrylate/ sodium acryloyldymethyl taurate copolymer, c20-22 alcohols, triethanolamine, isohexadecane, methylparaben, c14-22 alcohols, cetearyl glucoside, hydrolyzed adansonia digitata extract, butylparaben, cyclopentasiloxane, chlorphenesin, propylparaben, xanthan gum, disodium edta, acrylates/c10-30 alkyl acrylate crosspolymer, parfum (fragance), sorbic acid, polysorbate 60, cyclodextrin, c12-20 alkyl glucoside, faex extract (yeast extract), hydrolyzed algin, ethylparaben, chlorella vulgaris extract, maris aqua (sea water), isobutylparaben, silica, disodium succinate, ci42090 (blue 1).

Principal Display Panel 50 Ml Carton (PRINCIPAL DISPLAY PANEL - 50 ml Carton)

L'BEL

PARIS

REGRESSION

JOUR

protective complex against

the first signs of age

with spf 15 facial day lotion

normal to combination skin

50 ml e (1.6 fl.oz.)


Advanced Ingredient Data


Raw Label Data

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