Label: CERAMIDE LIFT AND FIRM DAY BROAD SPECTRUM SUNSCREEN SPF 30- octinoxate, oxybenzone, octisalate, octocrylene, and avobenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 67938-0964-1, 67938-0964-2 - Packager: Elizabeth Arden, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 18, 2013
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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.
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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
- OTC - ACTIVE INGREDIENT
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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
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - PURPOSE
- OTC - WHEN USING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CERAMIDE LIFT AND FIRM DAY BROAD SPECTRUM SUNSCREEN SPF 30
octinoxate, oxybenzone, octisalate, octocrylene, and avobenzone creamProduct 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)