La Roche Posay Laboratoire Dermatologique Anthelios Glow Daily Glow Sunscreen Bronze Cell Ox Shield Broad Spectrum Spf 35 Liquid
FDA Label NDC 82046-768

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 Glow Daily Glow Sunscreen Bronze Cell Ox Shield Broad Spectrum Spf 35 (NDC 82046-768). 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 3%

Homosalate 13%

Octisalate 5%

Octocrylene 6%

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

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 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
  • store at 20oC - 25oC (68oF - 77oF)

Inactive Ingredients

water, glycerin, dicaprylyl carbonate, alcohol denat., C12-22 alkyl acrylate/ hydroxyethylacrylate copolymer, dimethicone, silica, synthetic fluorphlogopite, zea mays (corn) starch, mica, iron oxides, phenoxyethanol, titanium dioxide, dimethicone/PEG-10/15 crosspolymer, hydroxyacetophenone, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, acrylamide/sodium acryloyldimethyltaurate copolymer, xanthan gum, arachidyl alcohol, chlorphenesin, caprylyl glycol, isohexadecane, behenyl alcohol, tocopherol, pentylene glycol, tetrasodium glutamate diacetate, diethylhexyl syringylidenemalonate, trisodium ethylenediamine disuccinate, arachidyl glucoside, citric acid, polysorbate 80, ammonium polyacryloyldimethyl taurate, cassia alata leaf extract, maltodextrin, sorbitan oleate, dipropylene glycol, glycine soja (soybean) oil, caprylic/capric triglyceride, tin oxide, disodium stearoyl glutamate, sodium citrate, aluminum hydroxide

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