Label: CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SPICE- octinoxate and titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL

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 July 5, 2013

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • DESCRIPTION

    - For normal to dry skin.

    - Medium to full coverage. Luminous finish.

    Makeup goes ultra to smooth, lift, and firm the look of skin. This moisturizing cream foundation with CPT technology, Ceramides, and Advanced Moisture Complex diminished the appearance of fine lines, perfects skin tone, and creates a luminous finish that lasts all day. Provides Broad Spectrum Sunscreen SPF 15 protection.

  • INDICATIONS AND USAGE

    To Use: Smooth onto face.

    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 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 4.0%, Titanium Dioxide 3.0%.

  • INACTIVE INGREDIENT

    Other Ingredients: Water/Aqua/Eau, Cyclopentasiloxane, Dimethicone, Isohexadecane, Mica, Glycerin, Sorbitan, Isostearate, Dimethicone Crosspolymer, Alumina, Caprylyl Dimethicone Ethoxy Glucoside, Aluminum/Magnesium Hydroxide Stearate, Ceramide 1, Ceramide 3, Ceramide 6 II, Alpinia Speciosa Leaf Extract, Hibiscus Abelmoschus Seed Extract, Trifolium Pratense (Clover) Flower Extract, Sodium Hyaluronate, Ascorbyl Palmitate, Retinyl palmitate, Tocopherol, Alanine, Aspartic Acide, Glumatic Acid, Silica Silyate, Acetyl Octatpeptide-3, Mannitol, Sodium PCA, Sorbitol, Trehalose, Urea, Lecithin, PCA Dimethicone, Phytosphingosine, Polyperfluoroethoxymethoxy Difluororethyl PEG Phostphate, Fructose, Glucose, Sucrose, Cholesterol, Sodium Lauroyl Lactylate, Polyquaternium-51, Dextrin, Butylene Glycol, Hexylene Glycol, Carbomer, Xanthan Gum, BHT, Sodium Choloride, Zinc Stearate, Benzoic Acid, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Pottasium Sorbate, Propylparaben, Chlorphenesin, Iron Oxides (CI 77481, CI 77482), Titanium Dioxide (CI 77891).

  • DOSAGE & ADMINISTRATION

    Smooth on to face.

  • 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 right away.

  • OTC - PURPOSE

    Provides SPF 15 sun protection.

  • OTC - WHEN USING

    Keep out of eyes.

  • PRINCIPAL DISPLAY PANEL

    CLFMCarton

    CLFMOnsert

    CLFMBaseLabel

     

  • INGREDIENTS AND APPEARANCE
    CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SPICE 
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0951
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.28 g  in 32 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.96 g  in 32 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    MICA (UNII: V8A1AW0880)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ALANINE (UNII: OF5P57N2ZX)  
    ASPARTIC ACID (UNII: 30KYC7MIAI)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    MANNITOL (UNII: 3OWL53L36A)  
    SORBITOL (UNII: 506T60A25R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    UREA (UNII: 8W8T17847W)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    SUCROSE (UNII: C151H8M554)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    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)  
    Product Characteristics
    ColorBROWN (Spice) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67938-0951-11 in 1 BOX
    1NDC:67938-0951-232 g in 1 JAR
    2NDC:67938-0951-325000 g in 1 PAIL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/05/2010
    Labeler - Elizabeth Arden, Inc (849222187)