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

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 moisture treatment for face, neck, and decolletage to quickly infuse skin with ceramides for a youth-restoring boost. Hydrates intensely throughout the day, leaving skin feeling softer and firmer. Diminishes the appearance of surface lines and targets deeper wrinkles. 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 ever 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 sunglasses.

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%, Octocrylene 2.2%, Avobenzone 2.0%.

INACTIVE INGREDIENT

Other Ingredients: Water/Aqua/Eau, Dimethicone, C12-15 Alkyl Benzoate, Butylene Glycol, Cyclopentasiloxane, Isostearyl Neopentanoate, Theobroma Cacao (Cocoa) Seed Butter, Dimethicone/Vinyl Cimethicon Crosspolymer, Butyrospermum Parkii (Shea Butter) Extract, PPG-2 Isoceteth-20 Acetate, Glycerin Caprylic/Capric Triglyceride, Ceramide 1, Ceramide 3, Ceramide 6 II, Apinia Speciosa Leaf Extract, Hibiscus Abelmoschuss Seed Extract, Trifolium Pratense (Clover) Flower Extract, Sodium Hyaluronate, Ascorbyl Palmitate, Retinyl Linoleate Retinyl Plamitate, Tocopherol, Tocopheryl Acetate, Cetearyl Dimethicon Crosspolymer, Isohexadecane, Acetyo Octapeptide-3, Propylene Glycol, Sodium PCA, Trehalose Urea, Hydrogenated Lecithin, Lecithin Phopholipids, Phytosphingosing, Polyphosphorylcholine Glycol Acrylate, Sucrose, Cetearly Alcohol, Cholesterorl, Sodium lauroyl Lactylate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 80, Trideceth-6, Acrylamide/Sodium Acrylate Copolymer, Polyquaternium-51, PEG-8, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Xanthan Gum, Sodium Hydroxide, BHT, Mineral Oil/Paraddinum Liquid/Huile Minerale, Dimethiconol. Phenyl Trimethicone, Parfum/Fragrance, Alpha-Isomethyl Ionone, Benzyl Benzoate, Butylphenyl Metyhlpropional, Citral, Citronellol, Eugenol, Geraniol, Hexyl Cinnamal Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool, Benzoic Acid, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Potassium Sorbate, Propylparaben, Chlorphenesin, Red 4 (CI 14700), Yellow 6 (CI15985).

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, octocrylene, and avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-0964
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.675 g  in 49 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2.45 g  in 49 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.45 g  in 49 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.078 g  in 49 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.98 g  in 49 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
COCOA BUTTER (UNII: 512OYT1CRR)
SHEANUT OIL (UNII: O88E196QRF)
PPG-2 ISOCETETH-20 ACETATE (UNII: BI6C7YO419)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
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)
ISOHEXADECANE (UNII: 918X1OUF1E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
TREHALOSE (UNII: B8WCK70T7I)
UREA (UNII: 8W8T17847W)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
SUCROSE (UNII: C151H8M554)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MINERAL OIL (UNII: T5L8T28FGP)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
BENZYL BENZOATE (UNII: N863NB338G)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
CITRAL (UNII: T7EU0O9VPP)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
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)
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: 67938-0964-1	1 in 1 BOX
1	NDC: 67938-0964-2	49 g in 1 JAR

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)