La Roche Posay Laboratoire Dermatologique Anthelios 60 Face Light Fluid Sunscreen Broad Spectrum Spf 60 Water Resistant 80 Minutes Lotion
FDA Label NDC 49967-496

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 60 Face Light Fluid Sunscreen Broad Spectrum Spf 60 Water Resistant 80 Minutes (NDC 49967-496). 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, flammable until dry., do not use, when using this product, stop use and ask a doctor if, 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

Flammable Until Dry.

Avoid fire, flame and heat during application.

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:

  • shake well before 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 in this container from excessive heat and direct sun

Inactive Ingredients

water, cyclopentasiloxane, alcohol denat., silica, dicaprylyl ether, styrene/acrylates copolymer, PEG-30 dipolyhydroxystearate, dimethicone, cyclohexasiloxane, polymethylsilsesquioxane, nylon-12, dicaprylyl carbonate, diethylhexyl syringlyidenemalonate, phenoxyethanol, lauryl  PEG/PPG-18/18 methicone, sodium chloride, caprylyl glycol, PEG-8 laurate, isostearyl alcohol, poly C10-30 alkyl acrylate, disteardimonium hectorite, p-anisic acid, caprylic/capric triglyceride, disodium EDTA, cassia alata leaf extract, maltodextrin, propylene carbonate, sodium dodecylbenzenesulfonate, tocopherol

Questions Or Comments?

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