FLORMAR DELICIOUS LIP STYLO SUNSCREEN BROAD SPECTRUM SPF 15 DS16 MEET SO BLACK- titanium dioxide stick

Flormar Delicious Lip Stylo Sunscreen Broad Spectrum SPF 15 DS16 Meet So Black by

Drug Labeling and Warnings

Flormar Delicious Lip Stylo Sunscreen Broad Spectrum SPF 15 DS16 Meet So Black 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

Titanium Dioxide 2%

Purpose

Sunscreen

Use

• 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

Stop use and ask a doctor if

rash occurs

Directions

• Apply on the center of the lips and blend
• 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 of 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.

Other information

Protect this product in this container from excessive heat and direct sun

Inactive ingredients

DIISOSTEARYL MALATE, TRIDECYL TRIMELLITATE, CASTOR (RICINUS COMMUNIS (CASTOR) SEED OIL, POLYETHYLENE, OCTYLDODECANOL, HYDROGENATED POLYDECENE, PHENYL TRIMETHICONE, POLYETHYLENE, MICROCRYSTALLINE WAX, SILICA, MICA, BIS-DIGLYCERYL POLYACYLADIPATE-2, TRIISOSTEARYL CITRATE, CANDELILLA (EUPHORBIA CERIFERA) WAX, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PENTAERTHRITYL TETRABEHENATE, POLYMETHYL METHACRYLATE, POLYBUTENE, SHEA (BUTYROSPERMUM PARKII) BUTTER, COCOA (THEOBROMA COCAO) SEED BUTTER, CAPRYLIC/CAPRIC TRIGLYCERIDE, LAUROYL LYSINE, FRAGRANCE, PEG-8, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, TOCOPHEROL, ORCHID (CYMBIDIUM GRANDIFLORUM) FLOWER EXTRACT, ASCORBYL PALMITATE, ASCORBIC ACID, CITRIC ACID, IRON OXIDES.

Product Label

INGREDIENTS AND APPEARANCE

FLORMAR DELICIOUS LIP STYLO SUNSCREEN BROAD SPECTRUM SPF 15 DS16 MEET SO BLACK 
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61722-241
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
TRIISOSTEARYL CITRATE (UNII: 50XT325OOH)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
LAUROYL LYSINE (UNII: 113171Q70B)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61722-241-00	1 in 1 BOX	01/30/2015
1		3 g 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	01/30/2015

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