FLORMAR CONCEALER SUNSCREEN BROAD SPECTRUM SPF 20 BEIGE - octinoxate cream 
Kosan Kozmetik Sanayi ve Ticaret A.S.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

flormar Concealer Cream Sunscreen Broad Spectrum SPF 20 BEIGE

flormar Concealer Cream Sunscreen Broad Spectrum SPF 20 BEIGE


Active ingredient

Octinoxate 5%

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.
  • After use, close the cap properly.
  • 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 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, butylene glycol, biosaccharide gum-4, PEG-10 dimethicone, polymethylsilsequioxane, disteardimonium hectorite, trimethylsiloxysilicate, glycerin, SD alcohol 40-B, phenoxyethanol, polysilicone-11, sodium chloride, sodium PCA, aluminum hydroxide, urea, alpha-glucan oligosaccharide, propanediol, triethoxycaprylylsilane, panthenol, mushroom (Fomes officinalis) extract, fragrance, ethylhexylglycerin, trehalose, leuconostoc/radish root ferment filtrate, algin, xanthan gum, polyquaternium-51, caprylyl glycol, hydrolyzed vegetable protein, sodium hyaluronate, pectin, arginine, proline, serine, glucose, carrageenan (Chondrus crispus), titanium dioxide, iron oxides.

flormar Concealer Cream Sunscreen Broad Spectrum SPF 20 BEIGE 12ml (61722-040-00)

Concealer Tube Label

Concealer Box Label

FLORMAR CONCEALER SUNSCREEN BROAD SPECTRUM SPF 20 BEIGE 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61722-040
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DIMETHICONE 
BUTYLENE GLYCOL 
DISTEARDIMONIUM HECTORITE 
GLYCERIN 
PHENOXYETHANOL 
SODIUM CHLORIDE 
SODIUM PYRROLIDONE CARBOXYLATE 
ALUMINUM HYDROXIDE 
UREA 
.ALPHA.-GLUCAN OLIGOSACCHARIDE 
PROPANEDIOL 
TRIETHOXYCAPRYLYLSILANE 
PANTHENOL 
LARICIFOMES OFFICINALIS FRUITING BODY 
ETHYLHEXYLGLYCERIN 
TREHALOSE 
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE 
SODIUM ALGINATE 
XANTHAN GUM 
CAPRYLYL GLYCOL 
HYALURONATE SODIUM 
PECTIN 
ARGININE 
PROLINE 
SERINE 
DEXTROSE 
CARRAGEENAN 
CHONDRUS CRISPUS 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61722-040-001 in 1 BOX
112 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/18/2014
Labeler - Kosan Kozmetik Sanayi ve Ticaret A.S. (644090409)
Establishment
NameAddressID/FEIBusiness Operations
Kosan Kozmetik Sanayi ve Ticaret A.S.644090409manufacture(61722-040)

Revised: 7/2014
 
Kosan Kozmetik Sanayi ve Ticaret A.S.