CERAMIDE PLUMP PERFECT LIP MOISTURE SPF 30- octinoxate cream

Ceramide Plump Perfect Lip Moisture SPF 30 by

Drug Labeling and Warnings

Ceramide Plump Perfect Lip Moisture SPF 30 by is a Otc medication manufactured, distributed, or labeled by Elizabeth Arden, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Lip plumping benefits plus moisture-boosting hydration and SPF 30 protection. Contains Maxi-Lip, a proven lip plump plump, and Argireline, a potent lip plumper. Together they help plump up lip volume and reduce the appearance of vertical lines for smoother, fuller-looking lips. Our moisture-rich Ceramide Triple Complex helps reinforce skin's own natural protective barrier. SPF 30 helps protect from the damaging effects of the sun.

INDICATIONS AND USAGE

To Use: Smooth over and around lips before sun exposure and lipstick application.

WARNINGS

WARNING: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rash appear. If irritation or rash persists, consult a doctor. Keep out of reach of children. Clinically, dermatologist, and allergy tested.

OTC - ACTIVE INGREDIENT

Active Ingredients: Octinoxate 7.50 %, Octisalate 5.00%, Avobenzone 3.00%, Oxybenzone 2.70%.

INACTIVE INGREDIENT

Other Ingredients: Water, Synthetic Beeswax, Pentylene Glycol, Dipentaerythrityl Tetrahyroxystearate/Tetreisostearate, Isostearyl Neopentanoate, Butylene Gloycol, Ceteareth-20, Isostearyl Alcohol, Cetearyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Caprylic/Capric Triglyceride, Butylene Glycol Cocoate, Polymethylmethacrylate, PPG-51/SMDI Coplymer, Ceramide 1, Ceramide 3, Ceramide 6 II, Alpinia Speciosa Leaf Extract, Butrospermum Park II (Shea Butter) Extract, Melissa Oficinalis (Balm Mint) Water, Mentha Piperita (Peppermint) Leaf Water, Rosmarinus Officinalis (Rosemary) Leaf Water, Trifolium Pratense (Clover) Flower Extract, Retinyl Linoleate, Tribehenin, Ethylhexyl Palmitate, Hydrogenated Polysobutene, PEG-40 Hydrogenated Castor Oil, Glycerin, Propylene Glycol, Acetyl Hexapeptide-3, Hydrogenated Lecithin, Lecithin, Palmitoyl Oligopeptide, Phospholipids, Phytospingosine, Polyphosphorylcholine Glycol, Acrylate, Fructose, Sucrose, Ammonium Acryloyldimethyl Taurate/VP Copolymer, BIS-PEG/PPG-16/16PEG/PPG-16/16 Dimethicone, Sorbitan Isostearate, Steareth-2, Tridecth-9, Polyether-1, Ethylcellulose, Ceteth-20, Colesterol, PEG-100 Stearate, Sodium Lauroyl Lactylate, Stearic Acid, Carbomer, Silica, Cyclopentasiloxane, Dimethicone, Flavor, Ammonium Cylcyrrhizate, Menthol, Benzoic Acid, Ethyl Maltol, Methylparaben, Phenoxyethanol, Propylparaben, Chlophenesin.

DOSAGE & ADMINISTRATION

Smooth over and around lips.

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTC - PURPOSE

Provides SPF 30 sun protection.

OTC - WHEN USING

Avoid contact with eyes.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAMIDE PLUMP PERFECT LIP MOISTURE SPF 30 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-0967
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.091 g  in 14.55 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.7275 g  in 14.55 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.4365 g  in 14.55 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.3928 g  in 14.55 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
COCOA BUTTER (UNII: 512OYT1CRR)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARETH-2 (UNII: V56DFE46J5)
CETETH-20 (UNII: I835H2IHHX)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
GLYCYRRHIZIN, AMMONIATED (UNII: 3VRD35U26C)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
STEARIC ACID (UNII: 4ELV7Z65AP)
CHLORPHENESIN (UNII: I670DAL4SZ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
MENTHOL (UNII: L7T10EIP3A)
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)
SUCROSE (UNII: C151H8M554)
FRUCTOSE (UNII: 6YSS42VSEV)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERIN (UNII: PDC6A3C0OX)
BENZOIC ACID (UNII: 8SKN0B0MIM)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
ETHYL MALTOL (UNII: L6Q8K29L05)
PEPPERMINT OIL (UNII: AV092KU4JH)
ROSEMARY OIL (UNII: 8LGU7VM393)
CERAMIDE 3 (UNII: 4370DF050B)
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)
XANTHAN GUM (UNII: TTV12P4NEE)
ACETYL HEXAPEPTIDE-3 (UNII: L4EL31FWIL)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALPINIA ZERUMBET LEAF (UNII: MS8P33AMKX)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-0967-1	1 in 1 BOX
1	NDC: 67938-0967-2	14.55 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/30/2004

Labeler - Elizabeth Arden, Inc (849222187)