FLORMAR REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP05 NUDE 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.

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flormar REBORN BB CREAM SUNSCREEN BROAD SPECTRUM SPF 30 CP05 Nude Beige

flormar REBORN BB CREAM SUNSCREEN BROAD SPECTRUM SPF 30 CP05 Nude 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 brokenskin

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

  • Apply to face with a make-up sponge.
  • 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

neopentyl glycol diethylhexanoate, ethylhexyl palmitate, polyethylene, hydrogenated polyisobutene, isononyl isononanoate, octyldodecyl stearoyl stearate, aluminum starch octenyl succinate, candelilla (Candelilla cera) wax, pentaerythrityl tetrabehenate, isocetyl stearoyl stearate, jojoba (Simmondsia chinensis) seed oil, squalane, nylon-12, polyglyceryl-3 diisostearate, cyclopentasiloxane, polymethylsilsesquioxane, dimethicone/vinyl dimethicone crosspolymer, triethoxycaprylylsilane, aluminum hydroxide, fragrance, polyglyceryl-3 polydimethyl siloxyethyl dimethicone, silica, stearic acid, PEG-8, tocopherol, ascorbyl palmitate, ascorbic acid, citric acid, linalool, butylphenyl methylpropional, alpha-isomethyl ionone, citronellol, benzyl salicylate, geraniol, coumarin, titanium dioxide, iron oxides

Product Labels

BB Cream InnerBB Cream OuterEnter section text here

FLORMAR REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP05 NUDE BEIGE 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61722-162
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
NEOPENTYL GLYCOL DIETHYLHEXANOATE 
ETHYLHEXYL PALMITATE 
HIGH DENSITY POLYETHYLENE 
ISONONYL ISONONANOATE 
OCTYLDODECYL STEAROYL STEARATE 
ALUMINUM STARCH OCTENYLSUCCINATE 
CANDELILLA WAX 
PENTAERYTHRITYL TETRABEHENATE 
ISOCETYL STEAROYL STEARATE 
JOJOBA OIL 
SQUALANE 
NYLON-12 
POLYGLYCERYL-3 DIISOSTEARATE 
CYCLOMETHICONE 5 
ALUMINUM HYDROXIDE 
SILICON DIOXIDE 
STEARIC ACID 
POLYETHYLENE GLYCOL 400 
TOCOPHEROL 
ASCORBYL PALMITATE 
ASCORBIC ACID 
CITRIC ACID MONOHYDRATE 
LINALOOL, (+/-)- 
BUTYLPHENYL METHYLPROPIONAL 
ISOMETHYL-.ALPHA.-IONONE 
.BETA.-CITRONELLOL, (R)- 
BENZYL SALICYLATE 
GERANIOL 
COUMARIN 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61722-162-001 in 1 BOX
112 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/06/2014
Labeler - Kosan Kozmetik Sanayi ve Ticaret A.S. (644090409)
Establishment
NameAddressID/FEIBusiness Operations
Kosan Kozmetik Sanayi ve Ticaret A.S.644090409manufacture(61722-162)

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