Flormar Perfect Coverage Foundation 118 Dark Brown
FDA Label NDC 61722-261

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 Perfect Coverage Foundation 118 Dark Brown (NDC 61722-261). 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 drug facts, active ingredient, purpose, uses, warnings, 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

Drug Facts

Active Ingredient

Octinoxate 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

  • 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 cancer and early skin aging.  To decrease this risk, regularly use a Broad Spectrum SPF value of15 or higher and other sun protection measures including:
  • Limit timein 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 this product in this container from excessive heat and direct sun

Inactive Ingredients

water, cyclopentasiloxane, isononyl isononanoate, diethylhexyl malate, butylene glycol, sorbitan olivate, HDI/trimethylol hexylactone crosspolymer, cetyl PEG/PPG-10/1 dimethicone, hexyl laurate, magnesium aluminum silicate, glycerin, sweet almond (Prunus amygdalus dulcis) oil, polyglyceryl-4 isostearate, hydrogenated olive (Olea europaea) oil, phenoxyethanol, aluminum hydroxide, polyglyceryl-3 polydimethyl siloxyethyl dimethicone, triethoxycaprylylsilane, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, olive (Olea europaea) fruit oil, stearic acid, bisabolol, fragrance, methylparaben, propylene glycol, olive (Olea europaea) oil unsaponifiables, PEG-8, silica, tocopherol, glyceryl acrylate/acrylic acid copolymer, ascorbyl palmitate, PVM/MA copolymer, ascorbic acid, citric acid, propylparaben, linalool, butylphenyl methylpropional, alpha-isomethyl ionone, citronellol, benzyl salicylate, citronellol, benzyl salicylate, geraniol, coumarin, titanium dioxide, iron oxides.

Package Labeling:

Bottle (Bottle)

Bottle (Bottle)

Box (Box)

Box (Box)

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