FLORMAR BB SHEER TINTED BEAUTY SUNSCREEN BROAD SPECTRUM SPF 15 02 LIGHT MEDIUM - 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.

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flormar BB Cream Sheer Tinted Beauty Sunscreen Broad Spectrum SPF 15 02 Light Medium

flormar BB Cream Sheer Tinted Beauty Sunscreen Broad Spectrum SPF 15 02 Light Medium


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

  • 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 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.
  • Keep the product cool.
  • After use, close the tube properly with cap.

Inactive ingredients

water, cyclopentasiloxane, butylene glycol, ethylhexyl methoxycinnamate, polysilicone-11, cetyl PEG/PPG-10/1 dimethicone, dimethicone, PEG-10 dimethicone, trimethylsiloxysilicate, disteardimonium hectorite, glycerin, SD alcohol 40-B, polymethylsilsesquioxane, phenoxyethanol, methy methacrylate cross-polymer, sodium chloride, fragrance, sodium PCA, ethylhexylglycerin, urea, triethoxycaprylylsilane, algae extract, laureth-12, soluble collagen, aluminum hydroxide, trehalose, leuconostoc/radish root ferment filtrate, polyquaternium-51, sodium hyaluronate, chlorphenesin, propylene glycol, fig (Ficus carica) fruit extract, cotton (Gossypium hirsutum) seed extract, linseed (Linum usitatissimum) seed extract, sodium dehydroacetate, caprylyl glycol, hexyl cinnamal, benzyl salicylate, butylphenyl methylpropional, alpha-isomethyl ionone, linalool.
may contain: titanium dioxide, iron oxides.

flormar BB Cream Sheer Tinted Beauty Sunscreen Broad Spectrum SPF 15 02 Light Medium 40ml (61722-002-00)

BB Cream Label

FLORMAR BB SHEER TINTED BEAUTY SUNSCREEN BROAD SPECTRUM SPF 15 02 LIGHT MEDIUM 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61722-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
BUTYLENE GLYCOL 
DIMETHICONE 
DISTEARDIMONIUM HECTORITE 
GLYCERIN 
PHENOXYETHANOL 
SODIUM CHLORIDE 
SODIUM PYRROLIDONE CARBOXYLATE 
ETHYLHEXYLGLYCERIN 
UREA 
TRIETHOXYCAPRYLYLSILANE 
LAURETH-12 
ALUMINUM HYDROXIDE 
TREHALOSE 
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE 
HYALURONATE SODIUM 
CHLORPHENESIN 
PROPYLENE GLYCOL 
FIG 
COTTON SEED 
FLAX SEED 
SODIUM DEHYDROACETATE 
CAPRYLYL GLYCOL 
.ALPHA.-HEXYLCINNAMALDEHYDE 
BENZYL SALICYLATE 
BUTYLPHENYL METHYLPROPIONAL 
ISOMETHYL-.ALPHA.-IONONE 
LINALOOL, (+/-)- 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61722-002-001 in 1 BOX
140 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/12/2014
Labeler - Kosan Kozmetik Sanayi ve Ticaret A.S. (644090409)
Establishment
NameAddressID/FEIBusiness Operations
Kosan Kozmetik Sanayi ve Ticaret A.S.644090409manufacture(61722-002)

Revised: 6/2014
 
Kosan Kozmetik Sanayi ve Ticaret A.S.