FLORMAR LIP MOISTURIZER CREAM CARMEL SUNSCREEN BROAD SPECTRUM SPF 15- octinoxate stick

Flormar Lip Moisturizer Cream Carmel Sunscreen Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Flormar Lip Moisturizer Cream Carmel Sunscreen Broad Spectrum SPF 15 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 6.8%

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

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

• Apply on the lips. Reapply when lips are exposed to strong sun for protection.
• 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 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.

                   Children under 6 months of age: Ask a doctor. 

Other information

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

Inactive ingredients

DIISOSTEARYL MALATE, TRIDECYL TRIMELLITATE, OCTYLDODECANOL, HYDROGENATED POLYDECENE, PHENYL TRIMETHICONE, POLYETHYLENE, BIS-DIGLYCERYL POLYACYLADIPATE-2, TRIISOSTEARYL CITRATE, SILICA, MICROCRYSTALLINE WAX, MICA, CANDELILLA (EUPHORBIA CERIFERA) WAX, ZINC OXIDE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, POLYMETHYL METHACRYLATE, PENTAERTHRITYL TETRABEHENATE, POLYBUTENE, SHEA (BUTYROSPERMUM PARKII) BUTTER, COCOA (THEOBROMA COCAO) SEED BUTTER, CASTOR (RICINUS COMMUNIS) SEED OIL, CAPRYLIC/CAPRIC TRIGLYCERIDE, LAUROYL LYSINE, FLAVOR, PEG-8, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, TOCOPHEROL, ORCHID (CYMBIDIUM GRANDIFLORUM) FLOWER EXTRACT, ASCORBYL PALMITATE, ASCORBIC ACID, CITRIC ACID, TITANIUM DIOXIDE, IRON OXIDES, D&C RED NO. 6., FD&C YELLOW NO.5 ALUMINUM LAKE.

Product Label

INGREDIENTS AND APPEARANCE

FLORMAR LIP MOISTURIZER CREAM CARMEL SUNSCREEN BROAD SPECTRUM SPF 15 
octinoxate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61722-253
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	68 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
OCTYLDECANOL (UNII: 07UG7TSU58)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIISOSTEARYL CITRATE (UNII: 50XT325OOH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
MICA (UNII: V8A1AW0880)
ZINC OXIDE (UNII: SOI2LOH54Z)
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)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 6 (UNII: 481744AI4O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61722-253-00	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)