Ceramide Plump Perfect Lip Moisture SPF 30

Dosage form: cream
Ingredients: OCTINOXATE 1.091g in 14.55g, OCTISALATE 0.7275g in 14.55g, AVOBENZONE 0.4365g in 14.55g, OXYBENZONE 0.3928g in 14.55g
Labeler: Elizabeth Arden, Inc
NDC Code: 67938-0967

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

BC0967

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.

CERAMIDE PLUMP PERFECT LIP MOISTURE SPF 30 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0967
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE1.091 g  in 14.55 g
OCTISALATE (OCTISALATE) OCTISALATE0.7275 g  in 14.55 g
AVOBENZONE (AVOBENZONE) AVOBENZONE0.4365 g  in 14.55 g
OXYBENZONE (OXYBENZONE) OXYBENZONE0.3928 g  in 14.55 g
Inactive Ingredients
Ingredient NameStrength
WATER 
PENTYLENE GLYCOL 
BUTYLENE GLYCOL 
POLYOXYL 20 CETOSTEARYL ETHER 
ISOSTEARYL ALCOHOL 
CETOSTEARYL ALCOHOL 
COCOA BUTTER 
MEDIUM-CHAIN TRIGLYCERIDES 
PEG-100 STEARATE 
PHENOXYETHANOL 
ETHYLHEXYL PALMITATE 
DIMETHICONE 
SILICON DIOXIDE 
STEARETH-2 
CETETH-20 
TRIBEHENIN 
GLYCYRRHIZIN, AMMONIATED 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
STEARIC ACID 
CHLORPHENESIN 
CYCLOMETHICONE 5 
ETHYLCELLULOSES 
MENTHOL 
TRIFOLIUM PRATENSE FLOWER 
SUCROSE 
FRUCTOSE 
METHYLPARABEN 
GLYCERIN 
BENZOIC ACID 
PROPYLENE GLYCOL 
SODIUM LAUROYL LACTYLATE 
ETHYL MALTOL 
PEPPERMINT OIL 
ROSEMARY OIL 
CERAMIDE 3 
PALMITOYL OLIGOPEPTIDE 
XANTHAN GUM 
ACETYL HEXAPEPTIDE-3 
PROPYLPARABEN 
ALPINIA ZERUMBET LEAF 
BUTYLPARABEN 
ETHYLPARABEN 
CHOLESTEROL 
ISOBUTYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:67938-0967-11 TUBE (1 TUBE) in 1 BOX
1NDC:67938-0967-214.55 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/30/2004
Labeler - Elizabeth Arden, Inc (849222187)

Revised: 07/2011
 
Elizabeth Arden, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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