La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Uv Broad Spectrum Spf 50 Sunscreen Skin Protectant Cream
FDA Label NDC 49967-199

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by L�oreal Usa Products Inc for the product La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Uv Broad Spectrum Spf 50 Sunscreen Skin Protectant (NDC 49967-199). 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 active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, 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

Active Ingredients

Dimethicone 1%

Homosalate 8%

Octisalate 5%

Octocrylene 5%

Zinc oxide 7%

Purpose

Skin protectant

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Uses

  • temporarily protects chapped or cracked skin
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do Not Use

on damaged or broken skin

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor If

rash occurs

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating.
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months of age: Ask a doctor

Other Information

  • protect the product in this container from excessive heat and direct sun

Inactive Ingredients

water, glycerin, propanediol, petrolatum, butyloctyl salicylate, panthenol, dimethicone, butyrospermum parkii (shea) butter, steareth-20, cellulose, ethylhexyl methoxycrylene, polymnia sonchifolia root juice, oryza sativa (rice) bran wax, steareth-2, sorbitan isostearate, madecassoside, triethoxycaprylylsilane, alpha-glucan oligosaccharide, mannose, ammonium polyacryldimethyl taurate, hydroxyacetophenone, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, hydroxyethylcellulose, caprylyl glycol, citric acid, trisodium ethylenediamine disuccinate, lactobacillus, maltodextrin, pentylene glycol, polyhydroxystearic acid, polysorbate 60, C12-22 alkyl acrylate/hydroxyethylacrylate copolymer, chlorphenesin

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