FLORMAR SMOOTH TOUCH FOUNDATION 12 AMBER- octinoxate 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 Smooth Touch Foundation 12 Amber

Drug Facts

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, dimethicone, cyclopentasiloxane, butylene glycol, PEG-10 dimethicone, polymethylsilsesquioxane, glycerin, trimethylsiloxysilicate, disteardimonium hectorite, SD alcohol 40-B, phenoxyethanol, sodium chloride, polysilicone-11, triethoxycaprylylsilane, aluminum hydroxide, sodium PCA, fragrance, urea, caprylic/capric triglyceride, ethylhexylglycerin, algae extract, soluble collagen, trehalose, leuconostoc/radish root ferment filtrate, polyquaternium-51, cymbidium grandiflorum flower extract, nelumbo nucifera flower extract, sodium hyaluronate, chlorphenesin, propylene glycol, fig (ficus carica) fruit extract, cotton (gossypium hirsutum) seed extract, linseed (linum usitatissimum seed extract, sodium dehydroacetate. may contain: titanium dioxide, iron oxides.

​Package Labeling:

Label12Outer12

FLORMAR SMOOTH TOUCH FOUNDATION 12 AMBER 
octinoxate aerosol
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61722-281
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
UREA (UNII: 8W8T17847W)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TREHALOSE (UNII: B8WCK70T7I)  
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
CYMBIDIUM HOOKERIANUM FLOWER (UNII: H2DJ03DI5I)  
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FIG (UNII: TGD87RII2U)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61722-281-001 in 1 BOX02/14/2016
130 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 finalpart35202/14/2016
Labeler - Kosan Kozmetik Sanayi ve Ticaret A.S. (644090409)

Revised: 10/2019
Document Id: 9530e8bf-7eda-ca9a-e053-2a95a90ab98f
Set id: 3b3098c0-d3a3-4cd4-ba49-95cf65e24fa7
Version: 3
Effective Time: 20191018
 
Kosan Kozmetik Sanayi ve Ticaret A.S.