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

  • 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 19, 2013

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

  • 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

    LFLCarton

    LFLOnsert

    LFLTube

  • INGREDIENTS AND APPEARANCE
    CERAMIDE LIFT AND FIRM DAY BROAD SPECTRUM SUNSCREEN SPF 30 
    octinoxate, oxybenzone, octisalate, and avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0802
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 g  in 50 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2.5 g  in 50 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 g  in 50 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67938-0802-11 in 1 BOX
    1NDC:67938-0802-250 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/27/2009
    Labeler - Elizabeth Arden, Inc (849222187)