Label: TINTED SPF 45- octinoxate, octisalate, zinc oxide 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 December 5, 2011

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

  • Revision Skincare 1.7oz Retail Intellishade®

        Intellishade®
        SPF 45 Original

         anti-aging
         tinted moisturizer
         for all skin types


         NT WT 1.7 OZ / 48 G

        Active Ingredient   Purpose

         Octinoxate 7.5%        Sunscreen
         Octisalate 5%            Sunscreen
         Zinc Oxide 2%           Sunscreen

        Uses
    • helps prevent sunburn
    • higher SPF gives more sun protection
    • for skin highly sensitive to sunburn

        Warnings

        for external use only

        When using this product

    • keep out of eyes, rinse with water to remove.

        Stop use and ask a doctor if
    • rash or irritation develops and lasts.

        Keep this and all drugs out of reach
        of children.
      If swallowed, get medical
        help or contact a Poison Control
        Center right away.

        Directions
    • apply evenly before sun exposure and as needed.

        Other Information
        High sun protection product

       Inactive ingredients
        Water (Aqua), Cyclopentasiloxane, Ethylhexyl Stearate, Sorbitol,
        Caprylic/Capric Triglyceride, Glycerin, Polyglyceryl-4 Isostearate,
        Cetyl PEG/PPG 10/1 Dimethicone, Hexyl Laurate, Aloe Barbadensis
        Leaf Juice, Cetyl Dimethicone, Betula Alba (White Birch) Extract,
        Camellia Sinensis (Green Tea) Leaf Extract, Plankton Extract,
        Beeswax, Dimethicone, Squalane, Tocopheryl Acetate, Tetrahexyldecyl
        Ascorbate, Hydrogenated Castor Oil, Lecithin, Butylene Glycol, Caprylyl
        Glycol, Palmitoyl Tripeptide-5, Saccharomyces Cerevisiae Extract,
        Ubiquinone, Retinyl Palmitate, Sodium Chloride, Phenoxyethanol,
        Chlorphenesin, Triethoxycaprylylsilane, Benzoic Acid, Sorbic Acid,
        Titanium Dioxide, Iron Oxides


        Dist. by Revision, Inc.
        Dallas, TX 75247 Made in U.S.A.
  • Revercel 1.7oz Retail Triple Duty Sunscreen

        triple duty
        sunscreen


        spf 45
        sheer tint


        net. wt. 1.7oz / 48g

         Active Ingredient   Purpose

         Octinoxate 7.50%        Sunscreen
         Octisalate 5.00%         Sunscreen
         Zinc Oxide 2.00%        Sunscreen

        Uses

    • Helps prevent sunburn.
    • Higher SPF gives more sun protection.
    • For skin highly sensitive to sunburn.

        Warnings

        For external use only.

        When using this product

    • Keep out of eyes. Rinse with water to remove.

        Stop use and ask a doctor if

    • Rash or irritation develops and lasts.

        Keep out of reach of children.
        If swallowed, get medical help or contact a
        Poison Control Center right away.

        Directions

    • Apply evenly before sun exposure and as needed.
    • Children under 6 months of age: ask a doctor.
    • Reapply as needed or after towel drying, swimming or perspiring.

        Other Information
        High sun protection product.

       Inactive ingredients
        Water (Aqua), Cyclopentasiloxane, Ethylhexyl Stearate, Sorbitol,
        Caprylic/Capric Triglyceride, Glycerin, Polyglyceryl-4 Isostearate,
        Cetyl PEG/PPG 10/1 Dimethicone, Hexyl Laurate, Aloe Barbadensis
        Leaf Juice, Cetyl Dimethicone, Betula Alba (White Birch) Extract,
        Camellia Sinensis (Green Tea) Leaf Extract, Plankton Extract,
        Beeswax, Dimethicone, Squalane, Tocopheryl Acetate, Tetrahexyldecyl
        Ascorbate, Hydrogenated Castor Oil, Lecithin, Butylene Glycol, Caprylyl
        Glycol, Palmitoyl Tripeptide-5, Saccharomyces Cerevisiae Extract,
        Ubiquinone, Retinyl Palmitate, Sodium Chloride, Phenoxyethanol,
        Chlorphenesin, Triethoxycaprylylsilane, Benzoic Acid, Sorbic Acid,
        Titanium Dioxide, Iron Oxides

    Made in the USA

    Distributed by Revercel, LLC
    Cambell, CA 95008

  • Revision Skincare 8oz Professional Intellishade®

    Intellishade®
    SPF 45 Original

    tinted moisturizer
    for all skin types


    NT WT 8 OZ / 227 G

         Skin Type:

        Suitable for all skin types to even out skin tone
        and protect against sunburn after procedures
        such as laser therapy, microdermabrasion and
        chemical peels.

        Active Ingredients:

        Octinoxate 7.5%, Octisalate 5.0%, Zinc Oxide 2.0%

        Key Ingredients and Benefits:

    • Broad spectrum sunscreens protect against UVA and UVB damage
    • Coenzyme Q10 and standardized Green Tea Extract provide antioxidant benefits
    • Natural minerals even out skin tone and conceal redness
    • THD Ascorbate (Vitamin C) and Palmitoyl Tripeptide-5 help reduce the appearance of fine lines and wrinkles

       

        Directions:

         Apply liberally to face and neck to help protect skin and conceal redness.


        Professional size only. Not for resale.

        Dist. by Revision, Inc
        Dallas, TX 75247 Made in U.S.A.

  • PRINCIPAL DISPLAY PANEL


    Intellishade® SPF 45 1.7oz Carton Image

    Triple Duty SPF 45 1.7oz Carton Image

    Intellishade® SPF 45 8oz Carton Image

    Intellishade® SPF 45 0.12oz Carton Image

  • INGREDIENTS AND APPEARANCE
    TINTED SPF 45 
    octinoxate, octisalate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10477-2627
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    SORBITOL (UNII: 506T60A25R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BETULA PUBESCENS BARK (UNII: 3R504894L9)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SQUALANE (UNII: GW89575KF9)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SORBIC ACID (UNII: X045WJ989B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10477-2627-11 in 1 CARTON
    148 g in 1 TUBE
    2NDC:10477-2627-2227 g in 1 TUBE
    3NDC:10477-2627-33 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/2007
    Labeler - Goodier Cosmetics, LP (007317209)
    Registrant - Goodier Cosmetics, LP (007317209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Goodier Cosmetics, LP007317209manufacture