L'bel

L'bel
SPL v1
SPL
SPL Set ID 8b89dfc4-2345-4329-9ace-957de14e5a81
Route
TOPICAL
Published
Effective Date 2010-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (2.25 mg) Octisalate (1.2 mg) Oxybenzone (0.075 mg)
Inactive Ingredients
Water C12-15 Alkyl Benzoate Snow Pea Cyclomethicone 6 Dimethicone Butylene Glycol Cetostearyl Alcohol Erythritol Phenoxyethanol Propylene Glycol Glyceryl Monostearate Trolamine Isohexadecane Methylparaben Butylparaben Cyclomethicone 5 Chlorphenesin Propylparaben Xanthan Gum Edetate Disodium Sorbic Acid Polysorbate 60 Glycerin Ethylparaben Isobutylparaben Silicon Dioxide

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.
  • use in the morning after cleansing and toning. Apply small amounts using the fingertips and spreading with upward, circular movements. Rub gently until absorbed completely.
  • children under 6 months of age: ask a doctor.
  • moderate sun protection product.
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.
Active Ingredients

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

Inactive Ingredients

Aqua (water), c12-15 alkyl benzoate, pisum sativum (pea) extract, cyclohexasiloxane, dimethicone, butylene glycol, cetearyl alcohol, erythritol, hdi/trimethylol hexyllactone crosspolymer, phenoxyethanol, sodium acrylate/acryloyldimethyltaurate/dimethylacrylamide crosspolymer, c20-22 alkyl phosphate, propyleneglycol, hydroxyethyl acrylate/sodium acryloyldymethyl taurate copolymer, glyceryl stearate, c20-22 alcohols, triethanolamine, isohexadecane, methylparaben, parfum (fragance), c14-22 alcohols, cetearyl glucoside, butylparaben, cyclopentasiloxane, chlorphenesin, propylparaben, xanthan gum, disodium edta, acrylates/c10-30 alkylacrilate crosspolymer, sorbic acid, polysorbate 60, c12-20 alkyl glucoside, glycerin, hydrolized algin, ethylparaben, chlorella vulgaris extract, maris aqua (sea water), isobutylparaben, silica, homarine hcl, rubus chamaemorus fruit extract.

Principal Display Panel 30 Ml Carton

L'BEL

PARIS

HYDRA CALME

SPF 15

intensive moisturizing facial

lotion SPF 15

30 ml e (1 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.
  • use in the morning after cleansing and toning. Apply small amounts using the fingertips and spreading with upward, circular movements. Rub gently until absorbed completely.
  • children under 6 months of age: ask a doctor.
  • moderate sun protection product.
Other Information (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.
Active Ingredients

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

Inactive Ingredients (Inactive ingredients)

Aqua (water), c12-15 alkyl benzoate, pisum sativum (pea) extract, cyclohexasiloxane, dimethicone, butylene glycol, cetearyl alcohol, erythritol, hdi/trimethylol hexyllactone crosspolymer, phenoxyethanol, sodium acrylate/acryloyldimethyltaurate/dimethylacrylamide crosspolymer, c20-22 alkyl phosphate, propyleneglycol, hydroxyethyl acrylate/sodium acryloyldymethyl taurate copolymer, glyceryl stearate, c20-22 alcohols, triethanolamine, isohexadecane, methylparaben, parfum (fragance), c14-22 alcohols, cetearyl glucoside, butylparaben, cyclopentasiloxane, chlorphenesin, propylparaben, xanthan gum, disodium edta, acrylates/c10-30 alkylacrilate crosspolymer, sorbic acid, polysorbate 60, c12-20 alkyl glucoside, glycerin, hydrolized algin, ethylparaben, chlorella vulgaris extract, maris aqua (sea water), isobutylparaben, silica, homarine hcl, rubus chamaemorus fruit extract.

Principal Display Panel 30 Ml Carton (PRINCIPAL DISPLAY PANEL - 30 ml Carton)

L'BEL

PARIS

HYDRA CALME

SPF 15

intensive moisturizing facial

lotion SPF 15

30 ml e (1 fl.oz.)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:07.113756 · Updated: 2026-03-14T22:52:27.184723