Label: SHISEIDO RADIANT LIFTING FOUNDATION D10- octinoxate and titanium dioxide cream
SHISEIDO RADIANT LIFTING FOUNDATION D20- octinoxate and titanium dioxide cream
SHISEIDO RADIANT LIFTING FOUNDATION D30- octinoxate and titanium dioxide 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 September 14, 2012

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:Purpose
    OCTINOXATE 3.4%Sunscreen
    TITANIUM DIOXIDE 5.8%Sunscreen
  • INDICATIONS & USAGE

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • 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

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

  • Directions

    For sunscreen use:

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • 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
    • children under 6 months: Ask a doctor
  • Inactive Ingredients

    WATER, GLYCERIN, DIMETHICONE, BUTYLENE GLYCOL, NYLON-12, DIETHYLHEXYL SUCCINATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PEG-10 DIMETHICONE, DIPHENYLSILOXY PHENYL TRIMETHICONE, BIS-BUTYLDIMETHICONE POLYGLYCERYL-3, POLYMETHYL METHACRYLATE, TOCOPHERYL ACETATE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, HYDROXYPROLINE, PEG/PPG-36/41 DIMETHYL ETHER, ALUMINUM HYDROXIDE, ALUMINUM DISTEARATE, CYCLOMETHICONE, DISTEARDIMONIUM HECTORITE, TRISODIUM EDTA, POLYSILICONE-2, TOCOPHEROL, ALUMINA, TRIETHOXYCAPRYLYLSILANE, SODIUM METABISULFITE, HYDRATED SILICA, BARIUM SULFATE, BHT, METHICONE, SYZYGIUM JAMBOS LEAF EXTRACT, TETRADECENE, HYDROGEN DIMETHICONE, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE, TIN OXIDE, PHENOXYETHANOL, SODIUM DEHYDROACETATE, IRON OXIDES, TITANIUM DIOXIDE, MICA,

  • Other information

    • protect this product in this container from excessive heat and direct sun.
  • Questions or comments?

    Call toll free 1-800-906-7503

  • PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - D10

    SHISEIDO

    D10

    Radiant Lifting
    Foundation

    Firming and Anti-wrinkle

    BROAD SPECTRUM
    SPF 17
    sunscreen

    30mL NET WT. 1.2 OZ.

    Principal Display Panel - 30mL Bottle Carton - D10
  • PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - D20

    SHISEIDO

    D20

    Radiant Lifting
    Foundation

    Firming and Anti-wrinkle

    BROAD SPECTRUM
    SPF 17
    sunscreen

    30mL NET WT. 1.2 OZ.

    Principal Display Panel - 30mL Bottle Carton - D20
  • PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - D30

    SHISEIDO

    D30

    Radiant Lifting
    Foundation

    Firming and Anti-wrinkle

    BROAD SPECTRUM
    SPF 17
    sunscreen

    30mL NET WT. 1.2 OZ.

    Principal Display Panel - 30mL Bottle Carton - D30
  • INGREDIENTS AND APPEARANCE
    SHISEIDO RADIANT LIFTING FOUNDATION   D10
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-326
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1220 mg  in 35.88 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2081 mg  in 35.88 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    NYLON-12 (UNII: 446U8J075B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    MICA (UNII: V8A1AW0880)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HYDROXYPROLINE (UNII: RMB44WO89X)  
    PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)  
    SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TETRADECENE (UNII: FW23481S7S)  
    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-326-101 in 1 CARTON
    135.88 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35208/01/2012
    SHISEIDO RADIANT LIFTING FOUNDATION   D20
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-327
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1220 mg  in 35.88 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2081 mg  in 35.88 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    NYLON-12 (UNII: 446U8J075B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    MICA (UNII: V8A1AW0880)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HYDROXYPROLINE (UNII: RMB44WO89X)  
    PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)  
    SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TETRADECENE (UNII: FW23481S7S)  
    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-327-101 in 1 CARTON
    135.88 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35208/01/2012
    SHISEIDO RADIANT LIFTING FOUNDATION   D30
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-328
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1220 mg  in 35.88 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2081 mg  in 35.88 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    NYLON-12 (UNII: 446U8J075B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    MICA (UNII: V8A1AW0880)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HYDROXYPROLINE (UNII: RMB44WO89X)  
    PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)  
    SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TETRADECENE (UNII: FW23481S7S)  
    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-328-101 in 1 CARTON
    135.88 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35208/01/2012
    Labeler - SHISEIDO AMERICA INC. (782677132)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHISEIDO AMERICA INC.782677132MANUFACTURE(52686-326, 52686-327, 52686-328) , ANALYSIS(52686-326, 52686-327, 52686-328)
    Establishment
    NameAddressID/FEIBusiness Operations
    Davlyn Industries Inc624436254MANUFACTURE(52686-326, 52686-327, 52686-328)