FLORMAR BB WHITE BW03 DARK MEDIUM- octinoxate, octocrylene, avobenzone aerosol 
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 White Cream BW03 Dark Medium

Drug Facts

Active ingredients

Octinoxate 5%

Octinoxate 2%

Avobenzone 1%

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, polysilicone-11, butylene glycol, cetyl PEG/PPG-10/1 dimethicone, PEG-10 dimethicone, trimethylsiloxysilicate, disteardimonium hectorite, SD alcohol 40-B, phenoxyethanol, polyglyceryl-3 polydimethyl siloxyethyl dimethicone, hydrolyzed vegetable flour, ascorbyl tetraisopalmitate, polymethylsilsesquioxane, sodium chloride, stearic acid, methyl methacrylate crosspolymer, silica, fragrance, ethylhexylglycerin, triethoxycaprylylsilane, aluminum hydroxide, laureth-12, caprylyl glycol, hexyl cinnamal benzyl salicylate, butylphenyl methylpropional, alpha-isomethyl ionone,linalool, may contain: titanium dioxide, iron oxides.

Package Labeling:

BW03 Dark Mediumtube2

FLORMAR BB WHITE BW03 DARK MEDIUM 
octinoxate, octocrylene, avobenzone aerosol
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61722-292
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
LAURETH-12 (UNII: OAH19558U1)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61722-292-001 in 1 BOX05/02/2016
140 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/02/2016
Labeler - Kosan Kozmetik Sanayi ve Ticaret A.S. (644090409)

Revised: 10/2019
Document Id: 95306de8-b2cd-5f08-e053-2995a90acb6d
Set id: 3d541159-f702-430d-9bfb-7439e88ae948
Version: 4
Effective Time: 20191018
 
Kosan Kozmetik Sanayi ve Ticaret A.S.