CERAMIDE LIFT AND FIRM DAY BROAD SPECTRUM SUNSCREEN SPF 30- octinoxate, oxybenzone, octisalate, and avobenzone lotion

Ceramide Lift And Firm Day Broad Spectrum Sunscreen SPF 30 by

Drug Labeling and Warnings

Ceramide Lift And Firm Day Broad Spectrum Sunscreen 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

A lightweight, oil-free lotion for face, neck, and decolletage to quickly infuse skin with ceramides for a youth-restoring boost. Absorbs quickly to provide intense hydration throughout the day, leaving skin feeling soft and firm. Diminished the appearance of surface lines and helps restore radiance for a more youthful looking complexion.

INDICATIONS AND USAGE

To Use: Apply to cleansed skin after Ceramide Capsules in the morning.

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

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 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-sleeve shirts, pants, hats, and sunglesses.

WARNINGS

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.

OTC - ACTIVE INGREDIENT

Active Ingredients: Octinoxate 7.5%, Oxybenzone 5.0%, Octisalate 5.0%, Avobenzone 2.0%.

INACTIVE INGREDIENT

Other Ingredients: Water/Aqua/Eau, Butylene Glycol, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Cetearyl Alcohol, Dimethicone, Styrene/Acrylates Copolymer, Glycerin, Dimethicone/Vinyl Dimethicone Crosspolymer, PPG-2 Isoceteth-20 Acetate, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea Butter) Extract, Caprylyl Methicone, Ceramide 1, Ceramide 3, Ceramide 6 II, Alpinia Speciosa Leaf Extract, Hibiscus Abeloschuss Seed Extract, Trifolium Pratense (Clover) Flower Extract, Sodium Hyaluronate, Ascorbyl Palmitate, Retinyl Linoleate, Retinyl Palmitate, Tocopherol, Tocopheryl Acetate, Hydrogenated Lecithin, Lecithin, Phospholipids, Phytosphingosine, Polyphosphorylcholine Glycol Acrylate, Sucrose, Cholesterol, Sodium Lauroyl Lactylate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-8 Laurate, Polysorbate 80, Potassium Cetyl Phosphate, Sodium Dodecylbenzenesulfonate, Polyquaternium-51, PEG-8, Carbomer, Xanthan Gum, Sodium Hydroxide, BHT, Disodium EDTA, Dimethiconol, Phenyl Trimethicone, Parfum/Fragrance, Alpha-Isomethyl Ionone, Benzyl Benzoate, Butylphenyl Methylpropional Citral, Citronellol, Eugenol, Geraniol, Hexyl Cinnamai, Hydroxyisohexyl 3-Cyclohexene, Carboxaldehyde Limonene, Linalool, Benzoic Acid, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Potassium Sorbate, Propylparaben, Sorbic Acid, Chlorphenesin, Red 4 (CI 14700), Yellow 6 (CI 15985).

DOSAGE & ADMINISTRATION

Apply to skin.

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 30 sun protection.

OTC - WHEN USING

Keep out of eyes.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAMIDE LIFT AND FIRM DAY BROAD SPECTRUM SUNSCREEN SPF 30 
octinoxate, oxybenzone, octisalate, and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-0802
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.75 g  in 50 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2.5 g  in 50 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 g  in 50 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
COCOA BUTTER (UNII: 512OYT1CRR)
SHEA BUTTER (UNII: K49155WL9Y)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 6 II (UNII: F1X8L2B00J)
ALPINIA ZERUMBET LEAF (UNII: MS8P33AMKX)
ABELMOSCHUS MOSCHATUS SEED (UNII: UN2QZ55I88)
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
RETINYL LINOLEATE (UNII: 61911N8D6W)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
ISOHEXADECANE (UNII: 918X1OUF1E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
TREHALOSE (UNII: B8WCK70T7I)
UREA (UNII: 8W8T17847W)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
SUCROSE (UNII: C151H8M554)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
PEG-8 LAURATE (UNII: 762O8IWA10)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
BENZYL BENZOATE (UNII: N863NB338G)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
CITRAL (UNII: T7EU0O9VPP)
EUGENOL (UNII: 3T8H1794QW)
GERANIOL (UNII: L837108USY)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
BENZOIC ACID (UNII: 8SKN0B0MIM)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SORBIC ACID (UNII: X045WJ989B)
CHLORPHENESIN (UNII: I670DAL4SZ)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-0802-1	1 in 1 BOX
1	NDC: 67938-0802-2	50 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/27/2009

Labeler - Elizabeth Arden, Inc (849222187)