FLORMAR REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF33 CHOCOLATE - 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 FOUNDATION CREAM SUNSCREEN BROAD SPECTRUM SPF 20 SF33 Chocolate

flormar REBORN FOUNDATION CREAM SUNSCREEN BROAD SPECTRUM SPF 20 SF33 Chocolate 30ml (61722-211-00)


Active ingredient

Octinoxate 5%

Purpose

Sunscreen

Uses

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

Other information

Inactive ingredients

water, cyclopentasiloxane, butylene glycol, cetyl PEG/PPG-10/1 dimethicone, dimethicone, PEG-10 dimethicone, propanediol, polysilicone-11, glycerin, SD alcohol 40-B, dimethicone/vinyl dimethicone crosspolymer, phenoxyethanol, disteardimonium hectorite, trimethylsiloxysilicate, methyl methacrylate crosspolymer, sodium chloride, triethoxycaprylysilane, aluminum hydroxide, sodium PCA, ethylhexylglycerin, fragrance, urea, Anogeissus leiocarpus bark extract, algae extract, soluble collagen, silica, laureth-12, trehalose, leuconostoc/radish root ferment filtrate, polyquaternium-51, sodium hyaluronate, chlorphenesin, propylene glycol, fig (Ficus carica) fruit extract, cotton (Gossypium hirsutum) seed extract, linseed (Linumusitatissium) seed extract, sodium dehydroacetate, caprylyl glycol, hexyl cinnamal, benzyl salicylate, butylphenyl methylpropional, alpha-isomethylionone, linalool, titanium dioxide, iron oxides.

Product Labels

Power Fusion 1Power Fusion 2

FLORMAR REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF33 CHOCOLATE  
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61722-211
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPANEDIOL (UNII: 5965N8W85T)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
UREA (UNII: 8W8T17847W)  
ANOGEISSUS LEIOCARPUS BARK (UNII: U5TP1X38RH)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
LAURETH-12 (UNII: OAH19558U1)  
TREHALOSE (UNII: B8WCK70T7I)  
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
COTTON SEED (UNII: DI0ZRJ0MXN)  
FLAX SEED (UNII: 4110YT348C)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61722-211-001 in 1 BOX07/06/2014
130 mL in 1 BOTTLE; 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: 952edeb0-6824-fe74-e053-2a95a90a8fbd
Set id: 21b35861-e495-4b3e-8a0a-926f432ebf08
Version: 3
Effective Time: 20191018
 
Kosan Kozmetik Sanayi ve Ticaret A.S.