FLORMAR REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP01 ROSE- 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 SUNSCREEN BROAD SPECTRUM SPF 30 CP01 Rose

Drug Facts


Active ingredient

Octinoxate 5%

Purpose

Sunscreen

Uses

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

Other information

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

Kosan Kozmetik Sanayi ve Ticaret A.S.

Gebze Organize Sanayi Bolgesi Ihsan Dede Cad.900.SK NO:133 Gebze, Kocaeli 41480 Turkey  Made in Turkey   www.flormar.com
A Cream that creates the appearance of all day skin perfection with sensorial comfort. Extreme wearing, light texture adapts to the skin's movements with a medium to high covering film. Glides on with a velvet soft feel that stays lightweight, soft and smooth. Application: Wash and rinse your latex sponge when you are finished with your application. Before you put your latex sponge into the container, be sure that it is dried. Keep away from direct sunlight and keep in a cool place. After use, close the cap properly. To report a serious adverse event contact [917] 768-7350

flormar  REBORN  BB CREAM  SUNSCREEN BROAD SPECTRUM SPF 30   Net Wt. 0.42 oz (12 g)

Product Labels

BB Cream InnerBB Cream OuterEnter section text here

FLORMAR REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP01 ROSE 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61722-160
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
CANDELILLA WAX (UNII: WL0328HX19)  
PENTAERYTHRITYL TETRABEHENATE (UNII: 9MNZ044IRY)  
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
JOJOBA OIL (UNII: 724GKU717M)  
SQUALANE (UNII: GW89575KF9)  
NYLON-12 (UNII: 446U8J075B)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
GERANIOL (UNII: L837108USY)  
COUMARIN (UNII: A4VZ22K1WT)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61722-160-001 in 1 BOX07/06/2014
112 g in 1 CONTAINER; Type 0: Not a Combination Product
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)

Revised: 10/2019
Document Id: 952ead8b-42ed-2ddd-e053-2a95a90a73af
Set id: 4630e97a-ae89-443d-878c-36c89ecf0b20
Version: 3
Effective Time: 20191018
 
Kosan Kozmetik Sanayi ve Ticaret A.S.