La Roche Posay New 50 Body And Face Spf 50 Mineral Anthelios Gentle 100 Percent Mineral Uv Filters Soft Finish With Cell Ox Shield Lotion
FDA Label NDC 49967-091

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 New 50 Body And Face Spf 50 Mineral Anthelios Gentle 100 Percent Mineral Uv Filters Soft Finish With Cell Ox Shield (NDC 49967-091). 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 drug facts, 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

Drug Facts

Titanium dioxide 5%

Zinc Oxide 15%

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 cuased 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:
  •    after 80 minutes of swimming or sweating
  •    immediately after towel drying
  •    at least every 2 hours
  • 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 is this container from excessive heat and direct sun

Inactive Ingredients

water, C12-15 alkyl benzoate, isohexadecane, isononyl isononanoate, dicaprylyl ether, PEG-30 dipolyhydroxystearate, polyglyceryl-4 isostearate, dicaprylyl carbonate, ethylene/acrylic acid copolymer, triethylhexanoin, silica, poly C10-30 alkyl acrylate, citric acid, phenoxyethanol, sodium chloride, caprylyl glycol, diethylhexyl syringylidenemalonate, triethoxycaprylylsilane, aluminum hydroxide, stearic acid, aluminum stearate, chlorphnesin, disteardimonium hectorite, alumina, polyhydroxystearic acid, tocopherol, p-ansic acid, capryloyl salicylic acid, xanthan gum, disodium EDTA, propylene carbonate, caprylic/capric triglyceride, cassia alata leaf extract, maltodextrin

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