Lbel
FDA Label NDC 13537-088

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ventura International Ltd for the product Lbel (NDC 13537-088). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

USA: Distributed by Ventura
International Ltd, San Francisco,
CA 94111.

Active Ingredients

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

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • provides moderate protection against sunburn

Warnings

  • For external use only

Otc - When Using

When using this product

  • Keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if

  • rash and irritation develops and lasts.

Otc - Keep Out Of Reach Of Children

  • 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.
  • 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.

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.)

Principal Display Panel (30 ml Carton)

Principal Display Panel (30 ml Carton)

* Please review the disclaimer below.