La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Daily Tone Correcting Primer Broad Spectrum Spf 50 Sunscreen Lotion
FDA Label NDC 49967-525

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 Anthelios 50 Mineral Daily Tone Correcting Primer Broad Spectrum Spf 50 Sunscreen (NDC 49967-525). 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 ingredient, purpose, uses, warnings, do not use, when using tjhis 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.

Active Ingredient

Titanium dioxide 25%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed (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 Tjhis 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 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 of 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

dimethicone, C12-15 alkyl benzoate, dicaprylyl ether, dimethicone/vinyl dimethicone crosspolymer, talc, triethylhexanoin, isohexadecane, styrene/acrylates copolymer, hydrogenated jojoba oil, aluminum hydroxide, stearic acid, aluminum stearate, iron oxides, silica silylate, alumina, polyhydroxystearic acid, PEG-8 lasurate, tocopherol, water, diethylhexyl syringylidenemalonate, laureth-4, disodium stearoyl glutamate, cassia alata leaf extract, maltodextrin, caprylic/capric triglyceride

Questions Or Comments?

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