FLORMAR SMOOTH TOUCH FOUNDATION 12 AMBER- octinoxate aerosol

Flormar Smooth Touch Foundation 12 Amber by

Drug Labeling and Warnings

Flormar Smooth Touch Foundation 12 Amber by is a Otc medication manufactured, distributed, or labeled by Kosan Kozmetik Sanayi ve Ticaret A.S.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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 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

• Shake well before use.
• After use, close the cap properly.
• 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 if 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.
• Keep the product cool.
• After use, close the tube properly with cap.

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:

INGREDIENTS AND APPEARANCE

FLORMAR SMOOTH TOUCH FOUNDATION 12 AMBER 
octinoxate aerosol

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61722-281
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61722-281-00	1 in 1 BOX	02/14/2016
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/14/2016

Labeler - Kosan Kozmetik Sanayi ve Ticaret A.S. (644090409)