Flormar Bb White Bw04 Medium Beige
FDA Label NDC 61722-293

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kosan Kozmetik Sanayi Ve Ticaret A.s. for the product Flormar Bb White Bw04 Medium Beige (NDC 61722-293). 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

Octinoxate 5%

Octinoxate 2%

Avobenzone 1%

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

  • Wear alone or under foundation.
  • Shake well before use.
  • Apply liberally 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 30 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.
  • Childrenn under 6 months of age: Ask a doctor.

Other Information

  • Protect the product in this container from excessive heat and direct sun.
  • Keep the product cool.
  • After use, close the tube properly with cap.

Inactive Ingredients

Water, cyclopentasiloxane, polysilicone-11, butylene glycol, cetyl PEG/PPG-10/1 dimethicone, PEG-10 dimethicone, trimethylsiloxysilicate, disteardimonium hectorite, SD alcohol 40-B, phenoxyethanol, polyglyceryl-3 polydimethyl siloxyethyl dimethicone, hydrolyzed vegetable flour, ascorbyl tetraisopalmitate, polymethylsilsesquioxane, sodium chloride, stearic acid, methyl methacrylate crosspolymer, silica, fragrance, ethylhexylglycerin, triethoxycaprylylsilane, aluminum hydroxide, laureth-12, caprylyl glycol, hexyl cinnamal benzyl salicylate, butylphenyl methylpropional, alpha-isomethyl ionone,linalool, may contain: titanium dioxide, iron oxides.

Package Labeling:

Tube3 (Tube3)

Tube3 (Tube3)

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