La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum Spf 40 Medium Lotion
FDA Label NDC 69625-210

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosmetique Active Production for the product La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum Spf 40 Medium (NDC 69625-210). 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

Titanium dioxide 17%

Zinc oxide 8%

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

  • shake well before use
  • apply generously 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • 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 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

isohexadecane, water, dimethicone, triethylhexanoin, c15-19 alkane, silica, c12-15 alkyl benzoate, caprylyl methicone, butyloctyl salicylate, iron oxides, aluminum stearate, dicaprylyl carbonate, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, alumina, polyhydroxystearic acid, PEG-9 polydimethylsiloxyethyl dimethicone, pentylene glycol, acrylates/dimethicone copolymer, aluminum hydroxide, stearic acid, niacinamide, phenoxyethanol, magnesium sulfate, caprylyl glycol, triethoxycaprylylsilane, disteardimonium hectorite, diethylhexyl syringylidenemalonate, tocopherol, disodium stearoyl glutamate, propylene carbonate, cassia alata leaf extract, maltodextrin, dipropylene glycol, sodium citrate, caprylic/capric triglyceride

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