CERAMIDE LIFT AND FIRM EYE SUNSCREEN SPF 15- octinoxate and oxybenzone cream

Ceramide Lift And Firm Eye Sunscreen SPF 15 by

Drug Labeling and Warnings

Ceramide Lift And Firm Eye Sunscreen SPF 15 by is a Otc medication manufactured, distributed, or labeled by Elizabeth Arden, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

An eye moisture treatment to diminish the appearance of fine lines and wrinkles, crow's feet, dark circles, and puffiness. Gently lifts and firms the look of skin in the eye area for a brighter, visibly youthful, and more rested look.

INDICATIONS AND USAGE

To Use: Pat gently to cleansed skin around the eye area.

For Sunscreen Use: Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.

WARNINGS

Warnings:

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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.

OTC - ACTIVE INGREDIENT

Active Ingredients: Octinoxate 4.09%, Oxybenzone 1.40%.

INACTIVE INGREDIENT

Othe Ingredients: Water/Aqua/Eau, Dimethicone, Cetyl Ricinoleate, Octinoxate, Cetearyl Alcohol, Glycerin, Synthetic Beeswax, Butylene Glycol, Stearyl Heptanoate, Myristal Myristate, Isononyl Isononanoate, Oxybenzone, Ammonium Acryloyldimethyltaurate/VP Copolymer, Copernicia Cerifera (Carnauba) Wax/Cera Carnauba/Cire de Carnauba, PPG-2 Isoceteth-20 Acetate, Ceteth-20, Penoxyethanol, Cyclopentasiloxane, Myristyl Laurate, PEG-100 Stearate, Ascorbyl Glucoside, Beeswax/Cera Alba/Cire d'Abeille, BIS-PEG-12 Dimethicone, PEG-20, Sorbitan Tristearate, Steareth-100, Hibiscus Abelmoschuss Seed Extract, Propylene Glycol, VP/Eicosense Copolymer, BHT, Diazolidnyl Urea, Disodium EDTA, Hesperidin Methyl Chalcone, Sodium Hydroxide, Steareth-20, Pyrus Malus (Apple) Fruit Extract, Camellia Sinensis Leaf Extract, Methylparaben, Sodium Lauroyl Lactylate, Xanthan Gum, Silica, Propylparaben, Glycine Soja (Soybean) Seed Extract, PVP, Ceramide 3, Chlorhexdine Digluconate, Phospholipids, Ceramide 6 II, Dipeptide-2, Phytosphingosine, Potassium Sorbate, Tocopheryl Acetate, Ascorbyl Palmitate, Palmitoyl Tetrapeptide-7, Acetyl Octapeptide-3, Ceramide 1.

DOSAGE & ADMINISTRATION

Pat around eyes.

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control center immediately.

OTC - PURPOSE

Provides SPF 15 sun protection.

OTC - WHEN USING

Keep out of eyes.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAMIDE LIFT AND FIRM EYE SUNSCREEN SPF 15 
octinoxate and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-0993
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.58896 g  in 14.4 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.2016 g  in 14.4 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL RICINOLEATE (UNII: 1P677500YD)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
STEARYL HEPTANOATE (UNII: 2M4UGL1NCN)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
CARNAUBA WAX (UNII: R12CBM0EIZ)
PPG-2 ISOCETETH-20 ACETATE (UNII: BI6C7YO419)
CETETH-20 (UNII: I835H2IHHX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MYRISTYL LAURATE (UNII: 58U0NZN2BT)
PEG-100 STEARATE (UNII: YD01N1999R)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
YELLOW WAX (UNII: 2ZA36H0S2V)
SORBITAN TRISTEARATE (UNII: 6LUM696811)
STEARETH-100 (UNII: 4OH5W9UM87)
ABELMOSCHUS MOSCHATUS SEED (UNII: UN2QZ55I88)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HESPERIDIN METHYLCHALCONE (UNII: 4T2GVA922X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARETH-20 (UNII: L0Q8IK9E08)
APPLE (UNII: B423VGH5S9)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
XANTHAN GUM (UNII: TTV12P4NEE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SOYBEAN (UNII: L7HT8F1ZOD)
CERAMIDE 3 (UNII: 4370DF050B)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)
CERAMIDE 6 II (UNII: F1X8L2B00J)
VALYLTRYPTOPHAN (UNII: 3G64B4AFQN)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
CERAMIDE 1 (UNII: 5THT33P7X7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-0993-1	1 in 1 BOX
1	NDC: 67938-0993-2	14.4 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/27/2010

Labeler - Elizabeth Arden, Inc (849222187)