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
Purpose

Sunscreen

Description

Drug Facts

Medication Information

Warnings
  • For external use only
Uses
  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • provides moderate protection against sunburn
Purpose

Sunscreen

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.
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.

Description

Drug Facts

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.
Active Ingredients

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

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

Warnings
  • For external use only
Uses
  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • provides moderate protection against sunburn
Purpose

Sunscreen

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.
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.

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.
Active Ingredients

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

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