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, CAPRYLIC/CAPRIC TRIGLYCERIDE, LAUROYL
LYSINE, FLAVOR, PEG-8, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, TOCOPHEROL, ORCHID (CYMBIDIUM GRANIFLORUM) FLOWER EXTRACT, ASCORBYL PALMITATE, ASCORBIC ACID, CITRIC ACID, TITANIUM DIOXIDE, D&C RED NO.28 ALUMINUM LAKE, D&C RED NO.6.

KOSAN KOZMETIK SANAYI VE TICARET A.S.

GEBZE ORGANIZE SANAYI BOLGESI IHSAN DEDE CAD.900.SK NO:133 GEBZE, KOCAELI 41480 TURKEY MADE IN TURKEY
WWW.FLORMAR.COM TO REPORT A SERIOUS ADVERSE EVENT CONTACT [971] 766 – 7350. THIS TRANSLUCENT AND BRIGHT
SPF 15 SUNSCREEN LIP MOISTURIZER COMES WITH A FRUITY AROMA TO GIVE YOUR LIPS A FRESH AND GLOSSY LOOK. THIS MOISTURIZING FORMULA HELPS MAKE THE LIPS FEEL SUPPLE, SMOOTH, AND SOFT. APPLY ON THE LIPS. REAPPLY WHEN LIPS ARE EXPOSED TO STRONG SUN FOR PROTECTION. LIP MOISTURIZER WATERMELON SUNSCREEN STICK BROAD SPECTRUM SPF 15

Product Labels

flormar LIP MOISTURIZER WATERMELON SUNSCREEN STICK BROAD SPECTRUM SPF 15 Net Wt. 0.11 oz (3 g)

LipBalm_Watermelon

LipBalm_Watermelon_inner

FLORMAR LIP MOISTURIZER WATERMELON SUNSCREEN STICK BROAD SPECTRUM SPF 15
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61722-251
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIISOSTEARYL CITRATE (UNII: 50XT325OOH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
MICA (UNII: V8A1AW0880)
CANDELILLA WAX (UNII: WL0328HX19)
ZINC OXIDE (UNII: SOI2LOH54Z)
PENTAERYTHRITYL TETRABEHENATE (UNII: 9MNZ044IRY)
SHEA BUTTER (UNII: K49155WL9Y)
COCOA BUTTER (UNII: 512OYT1CRR)
CASTOR OIL (UNII: D5340Y2I9G)
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)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 6 (UNII: 481744AI4O)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:61722-251-00	1 in 1 BOX	12/23/2014
1		3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	12/23/2014

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

Flormar Lip Moisturizer Watermelon Sunscreen Stick Broad Spectrum SPF 15