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

  • 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

If you are a consumer or patient please visit this version.

  • 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

    LFDCarton

    LFDOnsert

    LFDBaseLabel

  • INGREDIENTS AND APPEARANCE
    CERAMIDE LIFT AND FIRM DAY BROAD SPECTRUM SUNSCREEN SPF 30 
    octinoxate, oxybenzone, octisalate, octocrylene, and avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0964
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.675 g  in 49 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2.45 g  in 49 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.45 g  in 49 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.078 g  in 49 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.98 g  in 49 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67938-0964-11 in 1 BOX
    1NDC:67938-0964-249 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/27/2009
    Labeler - Elizabeth Arden, Inc (849222187)