La Roche Posay Laboratoire Dermatologique Anthelios 60 Ultra Light Sunscreen Broad Spectrum Spf 60 Water Resistant 80 Minutes Spray
FDA Label NDC 49967-008

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 Ultra Light Sunscreen Broad Spectrum Spf 60 Water Resistant 80 Minutes (NDC 49967-008). 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 2.68%

Homosalate 9.6%

Octisalate 2.88%

Octocrylene 5.38%

Oxybenzone 3.46%

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.
  • keep away from face to avoid breathing it

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:

●  spray generously and spread evenly by hand 15 minutes before sun exposure

● hold container 4 to 6 inches from the skin to apply

● do not spray directly into face. Spray on hands then apply to face.

● do not apply in windy conditions

● use in a well-ventilated area

●  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, dimethicone, isopropyl lauroyl sarcosinate, glycerin, styrene/acrylates copolymer, isotridecyl isononanoate, polyurethane-35, caprylyl methicone, octyldodecanol, phenoxyethanol, propylene glycol, caprylyl glycol, sodium stearoyl glutamate, polysorbate 61, glyceryl stearate, PEG-8 laurate, dimethiconol, octyldodecyl xyloside, PEG-12 dimethicone, p-anisic acid, stearyl alcohol, disodium EDTA, tocopherol, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin

Questions Or Comments?

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