Label: SHISEIDO PERFECT REFINING FOUNDATION I00- octinoxate and titanium dioxide cream
SHISEIDO PERFECT REFINING FOUNDATION I20- octinoxate and titanium dioxide cream
SHISEIDO PERFECT REFINING FOUNDATION I40- octinoxate and titanium dioxide cream
SHISEIDO PERFECT REFINING FOUNDATION I60- octinoxate and titanium dioxide cream
SHISEIDO PERFECT REFINING FOUNDATION I100- octinoxate and titanium dioxide cream
SHISEIDO PERFECT REFINING FOUNDATION B00- octinoxate and titanium dioxide cream
SHISEIDO PERFECT REFINING FOUNDATION B20- octinoxate and titanium dioxide cream
SHISEIDO PERFECT REFINING FOUNDATION B40- octinoxate and titanium dioxide cream
SHISEIDO PERFECT REFINING FOUNDATION B60- octinoxate and titanium dioxide cream
SHISEIDO PERFECT REFINING FOUNDATION B100- octinoxate and titanium dioxide cream
SHISEIDO PERFECT REFINING FOUNDATION O00- octinoxate and titanium dioxide cream
SHISEIDO PERFECT REFINING FOUNDATION O20- octinoxate and titanium dioxide cream
SHISEIDO PERFECT REFINING FOUNDATION O40- octinoxate and titanium dioxide cream
SHISEIDO PERFECT REFINING FOUNDATION O60- octinoxate and titanium dioxide cream
SHISEIDO PERFECT REFINING FOUNDATION O80- octinoxate and titanium dioxide cream

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    52686-232-60, 52686-233-60, 52686-234-60, 52686-235-60, view more
    52686-236-60, 52686-237-60, 52686-238-60, 52686-239-60, 52686-240-60, 52686-241-60, 52686-242-60, 52686-243-60, 52686-244-60, 52686-245-60, 52686-246-60
  • Packager: SHISEIDO AMERICA INC.
  • 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 December 19, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    OCTINOXATE 1.9%Sunscreen
    TITANIUM DIOXIDE 4.1%Sunscreen
  • Use

    • helps prevent sunburn
  • 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, DIMETHICONE, CYCLOMETHICONE, NYLON-12, SD ALCOHOL 40-B, DIETHYLHEXYL SUCCINATE, GLYCERIN, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PEG-10 DIMETHICONE, ERYTHRITOL, XYLITOL, SODIUM GLUTAMATE, POLYGLYCERYL-2 DIISOSTEARATE, PEG/PPG-36/41 DIMETHYL ETHER, SODIUM HYALURONATE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, PAEONIA ALBIFLORA ROOT EXTRACT, ALUMINUM HYDROXIDE, ALUMINUM DISTEARATE, ALUMINA, DISTEARDIMONIUM HECTORITE, TRIETHOXYCAPRYLYLSILANE, POLYSILICONE-2, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, BUTYLENE GLYCOL, TOCOPHEROL, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE, BARIUM SULFATE, SODIUM METABISULFITE, BHT, METHICONE, HYDROGEN DIMETHICONE, TETRADECENE, PHENOXYETHANOL, BENZOIC ACID, TITANIUM DIOXIDE, IRON OXIDES, ZINC OXIDE, 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 B 00 Tube Carton

    SHISEIDO

    B 00

    Perfect Refining
    Foundation

    All-Day Flawless,
    Optimal Moisture

    BROAD SPECTRUM
    SPF 15
    sunscreen

    30mL 1FL. OZ.

    PRINCIPAL DISPLAY PANEL - 30mL B 00 Tube Carton
  • PRINCIPAL DISPLAY PANEL - 30mL B 20 Tube Carton

    SHISEIDO

    B 20

    Perfect Refining
    Foundation

    All-Day Flawless,
    Optimal Moisture

    BROAD SPECTRUM
    SPF 15
    sunscreen

    30mL 1FL. OZ.

    PRINCIPAL DISPLAY PANEL - 30mL B 20 Tube Carton
  • PRINCIPAL DISPLAY PANEL - 30mL B 40 Tube Carton

    SHISEIDO

    B 40

    Perfect Refining
    Foundation

    All-Day Flawless,
    Optimal Moisture

    BROAD SPECTRUM
    SPF 15
    sunscreen

    30mL 1FL. OZ.

    PRINCIPAL DISPLAY PANEL - 30mL B 40 Tube Carton
  • PRINCIPAL DISPLAY PANEL - 30mL B 60 Tube Carton

    SHISEIDO

    B 60

    Perfect Refining
    Foundation

    All-Day Flawless,
    Optimal Moisture

    BROAD SPECTRUM
    SPF 15
    sunscreen

    30mL 1FL. OZ.

    PRINCIPAL DISPLAY PANEL - 30mL B 60 Tube Carton
  • PRINCIPAL DISPLAY PANEL - 30mL B 100 Tube Carton

    SHISEIDO

    B 100

    Perfect Refining
    Foundation

    All-Day Flawless,
    Optimal Moisture

    BROAD SPECTRUM
    SPF 15
    sunscreen

    30mL 1FL. OZ.

    PRINCIPAL DISPLAY PANEL - 30mL B 100 Tube Carton
  • PRINCIPAL DISPLAY PANEL - 30mL I 00 Tube Carton

    SHISEIDO

    I 00

    Perfect Refining
    Foundation

    All-Day Flawless,
    Optimal Moisture

    BROAD SPECTRUM
    SPF 15
    sunscreen

    30mL 1FL. OZ.

    PRINCIPAL DISPLAY PANEL - 30mL I 00 Tube Carton
  • PRINCIPAL DISPLAY PANEL - 30mL I 20 Tube Carton

    SHISEIDO

    I 20

    Perfect Refining
    Foundation

    All-Day Flawless,
    Optimal Moisture

    BROAD SPECTRUM
    SPF 15
    sunscreen

    30mL 1FL. OZ.

    PRINCIPAL DISPLAY PANEL - 30mL I 20 Tube Carton
  • PRINCIPAL DISPLAY PANEL - 30mL I 40 Tube Carton

    SHISEIDO

    I 40

    Perfect Refining
    Foundation

    All-Day Flawless,
    Optimal Moisture

    BROAD SPECTRUM
    SPF 15
    sunscreen

    30mL 1FL. OZ.

    PRINCIPAL DISPLAY PANEL - 30mL I 40 Tube Carton
  • PRINCIPAL DISPLAY PANEL - 30mL I 60 Tube Carton

    SHISEIDO

    I 60

    Perfect Refining
    Foundation

    All-Day Flawless,
    Optimal Moisture

    BROAD SPECTRUM
    SPF 15
    sunscreen

    30mL 1FL. OZ.

    PRINCIPAL DISPLAY PANEL - 30mL I 60 Tube Carton
  • PRINCIPAL DISPLAY PANEL - 30mL I 100 Tube Carton

    SHISEIDO

    I 100

    Perfect Refining
    Foundation

    All-Day Flawless,
    Optimal Moisture

    BROAD SPECTRUM
    SPF 15
    sunscreen

    30mL 1FL. OZ.

    PRINCIPAL DISPLAY PANEL - 30mL I 100 Tube Carton
  • PRINCIPAL DISPLAY PANEL - 30mL O 00 Tube Carton

    SHISEIDO

    O 00

    Perfect Refining
    Foundation

    All-Day Flawless,
    Optimal Moisture

    BROAD SPECTRUM
    SPF 15
    sunscreen

    30mL 1FL. OZ.

    PRINCIPAL DISPLAY PANEL - 30mL O 00 Tube Carton
  • PRINCIPAL DISPLAY PANEL - 30mL O 20 Tube Carton

    SHISEIDO

    O 20

    Perfect Refining
    Foundation

    All-Day Flawless,
    Optimal Moisture

    BROAD SPECTRUM
    SPF 15
    sunscreen

    30mL 1FL. OZ.

    PRINCIPAL DISPLAY PANEL - 30mL O 20 Tube Carton
  • PRINCIPAL DISPLAY PANEL - 30mL O 40 Tube Carton

    SHISEIDO

    O 40

    Perfect Refining
    Foundation

    All-Day Flawless,
    Optimal Moisture

    BROAD SPECTRUM
    SPF 15
    sunscreen

    30mL 1FL. OZ.

    PRINCIPAL DISPLAY PANEL - 30mL O 40 Tube Carton
  • PRINCIPAL DISPLAY PANEL - 30mL O 60 Tube Carton

    SHISEIDO

    O 60

    Perfect Refining
    Foundation

    All-Day Flawless,
    Optimal Moisture

    BROAD SPECTRUM
    SPF 15
    sunscreen

    30mL 1FL. OZ.

    PRINCIPAL DISPLAY PANEL - 30mL O 60 Tube Carton
  • PRINCIPAL DISPLAY PANEL - 30mL O 80 Tube Carton

    SHISEIDO

    O 80

    Perfect Refining
    Foundation

    All-Day Flawless,
    Optimal Moisture

    BROAD SPECTRUM
    SPF 15
    sunscreen

    30mL 1FL. OZ.

    PRINCIPAL DISPLAY PANEL - 30mL O 80 Tube Carton
  • INGREDIENTS AND APPEARANCE
    SHISEIDO PERFECT REFINING FOUNDATION  I00
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-232
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.63555 g  in 33.45 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.37145 g  in 33.45 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ERYTHRITOL (UNII: RA96B954X6)  
    MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)  
    XYLITOL (UNII: VCQ006KQ1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TETRADECENE (UNII: FW23481S7S)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-232-601 in 1 CARTON02/01/2011
    133.45 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2011
    SHISEIDO PERFECT REFINING FOUNDATION  I20
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-233
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.63555 g  in 33.45 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.37145 g  in 33.45 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ERYTHRITOL (UNII: RA96B954X6)  
    MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)  
    XYLITOL (UNII: VCQ006KQ1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TETRADECENE (UNII: FW23481S7S)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-233-601 in 1 CARTON02/01/2011
    133.45 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2011
    SHISEIDO PERFECT REFINING FOUNDATION  I40
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-234
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.63555 g  in 33.45 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.37145 g  in 33.45 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ERYTHRITOL (UNII: RA96B954X6)  
    MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)  
    XYLITOL (UNII: VCQ006KQ1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TETRADECENE (UNII: FW23481S7S)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-234-601 in 1 CARTON02/01/2011
    133.45 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2011
    SHISEIDO PERFECT REFINING FOUNDATION  I60
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-235
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.63555 g  in 33.45 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.37145 g  in 33.45 g
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TETRADECENE (UNII: FW23481S7S)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    MICA (UNII: V8A1AW0880)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ERYTHRITOL (UNII: RA96B954X6)  
    MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-235-601 in 1 CARTON02/01/2011
    133.45 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2011
    SHISEIDO PERFECT REFINING FOUNDATION  I100
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-236
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.63555 g  in 33.45 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.37145 g  in 33.45 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ERYTHRITOL (UNII: RA96B954X6)  
    MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)  
    XYLITOL (UNII: VCQ006KQ1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TETRADECENE (UNII: FW23481S7S)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-236-601 in 1 CARTON02/01/2011
    133.45 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2011
    SHISEIDO PERFECT REFINING FOUNDATION  B00
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-237
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.63555 g  in 33.45 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.37145 g  in 33.45 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ERYTHRITOL (UNII: RA96B954X6)  
    MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)  
    XYLITOL (UNII: VCQ006KQ1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TETRADECENE (UNII: FW23481S7S)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-237-601 in 1 CARTON02/01/2011
    133.45 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2011
    SHISEIDO PERFECT REFINING FOUNDATION  B20
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-238
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.63555 g  in 33.45 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.37145 g  in 33.45 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ERYTHRITOL (UNII: RA96B954X6)  
    MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)  
    XYLITOL (UNII: VCQ006KQ1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TETRADECENE (UNII: FW23481S7S)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-238-601 in 1 CARTON02/01/2011
    133.45 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2011
    SHISEIDO PERFECT REFINING FOUNDATION  B40
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-239
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.63555 g  in 33.45 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.37145 g  in 33.45 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ERYTHRITOL (UNII: RA96B954X6)  
    MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)  
    XYLITOL (UNII: VCQ006KQ1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TETRADECENE (UNII: FW23481S7S)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-239-601 in 1 CARTON02/01/2011
    133.45 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2011
    SHISEIDO PERFECT REFINING FOUNDATION  B60
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-240
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.63555 g  in 33.45 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.37145 g  in 33.45 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ERYTHRITOL (UNII: RA96B954X6)  
    MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)  
    XYLITOL (UNII: VCQ006KQ1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TETRADECENE (UNII: FW23481S7S)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-240-601 in 1 CARTON02/01/2011
    133.45 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2011
    SHISEIDO PERFECT REFINING FOUNDATION  B100
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-241
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.63555 g  in 33.45 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.37145 g  in 33.45 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ERYTHRITOL (UNII: RA96B954X6)  
    MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)  
    XYLITOL (UNII: VCQ006KQ1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TETRADECENE (UNII: FW23481S7S)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-241-601 in 1 CARTON02/01/2011
    133.45 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2011
    SHISEIDO PERFECT REFINING FOUNDATION  O00
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-242
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.63555 g  in 33.45 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.37145 g  in 33.45 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ERYTHRITOL (UNII: RA96B954X6)  
    MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)  
    XYLITOL (UNII: VCQ006KQ1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TETRADECENE (UNII: FW23481S7S)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-242-601 in 1 CARTON02/01/2011
    133.45 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2011
    SHISEIDO PERFECT REFINING FOUNDATION  O20
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-243
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.63555 g  in 33.45 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.37145 g  in 33.45 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ERYTHRITOL (UNII: RA96B954X6)  
    MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)  
    XYLITOL (UNII: VCQ006KQ1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TETRADECENE (UNII: FW23481S7S)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-243-601 in 1 CARTON02/01/2011
    133.45 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2011
    SHISEIDO PERFECT REFINING FOUNDATION  O40
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-244
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.63555 g  in 33.45 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.37145 g  in 33.45 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ERYTHRITOL (UNII: RA96B954X6)  
    MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)  
    XYLITOL (UNII: VCQ006KQ1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TETRADECENE (UNII: FW23481S7S)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-244-601 in 1 CARTON02/01/2011
    133.45 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2011
    SHISEIDO PERFECT REFINING FOUNDATION  O60
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-245
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.63555 g  in 33.45 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.37145 g  in 33.45 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ERYTHRITOL (UNII: RA96B954X6)  
    MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)  
    XYLITOL (UNII: VCQ006KQ1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TETRADECENE (UNII: FW23481S7S)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-245-601 in 1 CARTON02/01/2011
    133.45 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2011
    SHISEIDO PERFECT REFINING FOUNDATION  O80
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-246
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.63555 g  in 33.45 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.37145 g  in 33.45 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    NYLON-12 (UNII: 446U8J075B)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ERYTHRITOL (UNII: RA96B954X6)  
    MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)  
    XYLITOL (UNII: VCQ006KQ1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TETRADECENE (UNII: FW23481S7S)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-246-601 in 1 CARTON02/01/2011
    133.45 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2011
    Labeler - SHISEIDO AMERICA INC. (782677132)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHISEIDO AMERICA INC.782677132manufacture(52686-232, 52686-233, 52686-234, 52686-235, 52686-236, 52686-237, 52686-238, 52686-239, 52686-240, 52686-241, 52686-242, 52686-243, 52686-244, 52686-245, 52686-246) , analysis(52686-232, 52686-233, 52686-234, 52686-235, 52686-236, 52686-237, 52686-238, 52686-239, 52686-240, 52686-241, 52686-242, 52686-243, 52686-244, 52686-245, 52686-246)