La Roche Posay Laboratoire Dermatologique Mela B3 Uv Daily Sunscreen Broad Spectrum Spf 30 Lotion
FDA Label NDC 49967-113

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 Mela B3 Uv Daily Sunscreen Broad Spectrum Spf 30 (NDC 49967-113). 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

Avobenzone 3%
Homosalate 10%
Octisalate 5%
Octocrylene 7%

Purpose

Sunscreen

Uses

  • 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 generously 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistat 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 meausures 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
  • store at 20° - 25° C (68° - 77° F)

Inactive Ingredients

water, c15-19 alkane, niacinamide, glycerin, butylene glycol, silica, titanium dioxide, butyrospermum parkii (shea) butter, tin oxide, potassium hydroxide, carbomer, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, 2-mercaptonicotinoyl glycine, sodium dilauramidoglutamide lysine, sodium thiosulfate, ammonium acryloyldimethyltaurate/VP copolymer, hydroxyacetophenone, capryloyl salicylic acid, caprylyl glycol, citric acid, trisodium ethylenediamine disuccinate, xanthan gum, pentylene glycol, poly c10-30 alkyl acrylate, polyglyceryl-4 caprate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, red 4, mica, fragrance

Questions Or Comments?

1-888-577-5226   1-888-LRP LABO

Monday - Friday (9 a.m. - 5 p.m. EST)

Package Label.Principal Display Panel

Image Description (Lrpmelabuvc)

Image Description (Lrpmelabuvc)

Image Description (Lrpmelabuvc)

Image Description (Lrpmelabuvc)

* Please review the disclaimer below.