Label: SHISEIDO SHEER AND PERFECT FOUNDATION I00- octinoxate and titanium dioxide emulsion
SHISEIDO SHEER AND PERFECT FOUNDATION I20- octinoxate and titanium dioxide emulsion
SHISEIDO SHEER AND PERFECT FOUNDATION I40- octinoxate and titanium dioxide emulsion
SHISEIDO SHEER AND PERFECT FOUNDATION I60- octinoxate and titanium dioxide emulsion
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Contains inactivated NDC Code(s)
NDC Code(s): 58411-103-10, 58411-104-10, 58411-105-10, 58411-106-10, view more58411-107-10, 58411-108-10, 58411-109-10, 58411-110-10, 58411-111-10, 58411-112-10, 58411-113-10, 58411-114-10, 58411-115-10, 58411-116-10, 58411-117-10, 58411-118-10, 58411-119-10, 58411-120-10 - Packager: SHISEIDO AMERICAS CORPORATION
- 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 19, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
- Warnings
-
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, SD ALCOHOL 40-B, NYLON-12, GLYCERIN, PEG-10 DIMETHICONE, DIPHENYLSILOXY PHENYL TRIMETHICONE, DIETHYLHEXYL SUCCINATE, POLYGLYCERYL-2 DIISOSTEARATE, ERYTHRITOL, XYLITOL, GLYCYL GLYCINE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SODIUM HYALURONATE, PAEONIA ALBIFLORA ROOT EXTRACT, PEG/PPG-36/41 DIMETHYL ETHER, ZINGIBER AROMATICUS EXTRACT, DIMETHICONE/PEG-10/15 CROSSPOLYMER, ALUMINUM HYDROXIDE, ALUMINUM DISTEARATE, DISODIUM EDTA, ALUMINA, POLYSILICONE-2, SODIUM CITRATE, TRIETHOXYCAPRYLYLSILANE, BHT, ALCOHOL, BUTYLENE GLYCOL, TOCOPHEROL, CITRIC ACID, DIPROPYLENE GLYCOL, BARIUM SULFATE, SODIUM METABISULFITE, METHICONE, TETRADECENE, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE, PHENOXYETHANOL, SODIUM DEHYDROACETATE, BENZOIC ACID, FRAGRANCE, IRON OXIDES, TITANIUM DIOXIDE, MICA,
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - I00
- PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - I20
- PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - I40
- PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - I60
- PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - I100
- PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - B00
- PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - B20
- PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - B40
- PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - B60
- PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - B100
- PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - O00
- PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - O20
- PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - O40
- PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - O60
- PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - O80
- PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - D10
- PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - D20
- PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - D30
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INGREDIENTS AND APPEARANCE
SHISEIDO SHEER AND PERFECT FOUNDATION I00
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 948 mg in 32.7 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1700 mg in 32.7 g Inactive Ingredients Ingredient Name Strength FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE (UNII: NMQ347994Z) NYLON-12 (UNII: 446U8J075B) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) DIGLYCINE (UNII: 10525P22U0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) EDETATE DISODIUM (UNII: 7FLD91C86K) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIPROPYLENE GLYCOL (UNII: E107L85C40) BARIUM SULFATE (UNII: 25BB7EKE2E) SODIUM METABISULFITE (UNII: 4VON5FNS3C) METHICONE (20 CST) (UNII: 6777U11MKT) TETRADECENE (UNII: FW23481S7S) DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) BENZOIC ACID (UNII: 8SKN0B0MIM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-103-10 1 in 1 CARTON 08/01/2013 1 32.7 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2013 SHISEIDO SHEER AND PERFECT FOUNDATION I20
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 948 mg in 32.7 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1700 mg in 32.7 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE (UNII: NMQ347994Z) NYLON-12 (UNII: 446U8J075B) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) DIGLYCINE (UNII: 10525P22U0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) EDETATE DISODIUM (UNII: 7FLD91C86K) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIPROPYLENE GLYCOL (UNII: E107L85C40) BARIUM SULFATE (UNII: 25BB7EKE2E) SODIUM METABISULFITE (UNII: 4VON5FNS3C) METHICONE (20 CST) (UNII: 6777U11MKT) TETRADECENE (UNII: FW23481S7S) DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) BENZOIC ACID (UNII: 8SKN0B0MIM) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-104-10 1 in 1 CARTON 08/01/2013 1 32.7 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2013 SHISEIDO SHEER AND PERFECT FOUNDATION I40
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-105 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 948 mg in 32.7 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1700 mg in 32.7 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE (UNII: NMQ347994Z) NYLON-12 (UNII: 446U8J075B) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) DIGLYCINE (UNII: 10525P22U0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) EDETATE DISODIUM (UNII: 7FLD91C86K) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIPROPYLENE GLYCOL (UNII: E107L85C40) BARIUM SULFATE (UNII: 25BB7EKE2E) SODIUM METABISULFITE (UNII: 4VON5FNS3C) METHICONE (20 CST) (UNII: 6777U11MKT) TETRADECENE (UNII: FW23481S7S) DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) BENZOIC ACID (UNII: 8SKN0B0MIM) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-105-10 1 in 1 CARTON 08/01/2013 1 32.7 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2013 SHISEIDO SHEER AND PERFECT FOUNDATION I60
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-106 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 948 mg in 32.7 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1700 mg in 32.7 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE (UNII: NMQ347994Z) NYLON-12 (UNII: 446U8J075B) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) DIGLYCINE (UNII: 10525P22U0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) EDETATE DISODIUM (UNII: 7FLD91C86K) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIPROPYLENE GLYCOL (UNII: E107L85C40) BARIUM SULFATE (UNII: 25BB7EKE2E) SODIUM METABISULFITE (UNII: 4VON5FNS3C) METHICONE (20 CST) (UNII: 6777U11MKT) TETRADECENE (UNII: FW23481S7S) DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) BENZOIC ACID (UNII: 8SKN0B0MIM) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-106-10 1 in 1 CARTON 08/01/2013 1 32.7 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2013 SHISEIDO SHEER AND PERFECT FOUNDATION I100
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-107 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 948 mg in 32.7 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1700 mg in 32.7 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE (UNII: NMQ347994Z) NYLON-12 (UNII: 446U8J075B) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) DIGLYCINE (UNII: 10525P22U0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) EDETATE DISODIUM (UNII: 7FLD91C86K) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIPROPYLENE GLYCOL (UNII: E107L85C40) BARIUM SULFATE (UNII: 25BB7EKE2E) SODIUM METABISULFITE (UNII: 4VON5FNS3C) METHICONE (20 CST) (UNII: 6777U11MKT) TETRADECENE (UNII: FW23481S7S) DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) BENZOIC ACID (UNII: 8SKN0B0MIM) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-107-10 1 in 1 CARTON 08/01/2013 1 32.7 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2013 SHISEIDO SHEER AND PERFECT FOUNDATION B00
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-108 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 948 mg in 32.7 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1700 mg in 32.7 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE (UNII: NMQ347994Z) NYLON-12 (UNII: 446U8J075B) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) DIGLYCINE (UNII: 10525P22U0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) EDETATE DISODIUM (UNII: 7FLD91C86K) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIPROPYLENE GLYCOL (UNII: E107L85C40) BARIUM SULFATE (UNII: 25BB7EKE2E) SODIUM METABISULFITE (UNII: 4VON5FNS3C) METHICONE (20 CST) (UNII: 6777U11MKT) TETRADECENE (UNII: FW23481S7S) DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) BENZOIC ACID (UNII: 8SKN0B0MIM) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-108-10 1 in 1 CARTON 08/01/2013 1 32.7 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2013 SHISEIDO SHEER AND PERFECT FOUNDATION B20
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-109 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 948 mg in 32.7 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1700 mg in 32.7 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE (UNII: NMQ347994Z) NYLON-12 (UNII: 446U8J075B) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) DIGLYCINE (UNII: 10525P22U0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) EDETATE DISODIUM (UNII: 7FLD91C86K) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIPROPYLENE GLYCOL (UNII: E107L85C40) BARIUM SULFATE (UNII: 25BB7EKE2E) SODIUM METABISULFITE (UNII: 4VON5FNS3C) METHICONE (20 CST) (UNII: 6777U11MKT) TETRADECENE (UNII: FW23481S7S) DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) BENZOIC ACID (UNII: 8SKN0B0MIM) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-109-10 1 in 1 CARTON 08/01/2013 1 32.7 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2013 SHISEIDO SHEER AND PERFECT FOUNDATION B40
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-110 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 948 mg in 32.7 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1700 mg in 32.7 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE (UNII: NMQ347994Z) NYLON-12 (UNII: 446U8J075B) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) DIGLYCINE (UNII: 10525P22U0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) EDETATE DISODIUM (UNII: 7FLD91C86K) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIPROPYLENE GLYCOL (UNII: E107L85C40) BARIUM SULFATE (UNII: 25BB7EKE2E) SODIUM METABISULFITE (UNII: 4VON5FNS3C) METHICONE (20 CST) (UNII: 6777U11MKT) TETRADECENE (UNII: FW23481S7S) DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) BENZOIC ACID (UNII: 8SKN0B0MIM) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-110-10 1 in 1 CARTON 08/01/2013 1 32.7 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2013 SHISEIDO SHEER AND PERFECT FOUNDATION B60
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 948 mg in 32.7 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1700 mg in 32.7 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE (UNII: NMQ347994Z) NYLON-12 (UNII: 446U8J075B) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) DIGLYCINE (UNII: 10525P22U0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) EDETATE DISODIUM (UNII: 7FLD91C86K) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIPROPYLENE GLYCOL (UNII: E107L85C40) BARIUM SULFATE (UNII: 25BB7EKE2E) SODIUM METABISULFITE (UNII: 4VON5FNS3C) METHICONE (20 CST) (UNII: 6777U11MKT) TETRADECENE (UNII: FW23481S7S) DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) BENZOIC ACID (UNII: 8SKN0B0MIM) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-111-10 1 in 1 CARTON 08/01/2013 1 32.7 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2013 SHISEIDO SHEER AND PERFECT FOUNDATION B100
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-112 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 948 mg in 32.7 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1700 mg in 32.7 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE (UNII: NMQ347994Z) NYLON-12 (UNII: 446U8J075B) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) DIGLYCINE (UNII: 10525P22U0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) EDETATE DISODIUM (UNII: 7FLD91C86K) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIPROPYLENE GLYCOL (UNII: E107L85C40) BARIUM SULFATE (UNII: 25BB7EKE2E) SODIUM METABISULFITE (UNII: 4VON5FNS3C) METHICONE (20 CST) (UNII: 6777U11MKT) TETRADECENE (UNII: FW23481S7S) DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) BENZOIC ACID (UNII: 8SKN0B0MIM) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-112-10 1 in 1 CARTON 08/01/2013 1 32.7 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2013 SHISEIDO SHEER AND PERFECT FOUNDATION O00
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-113 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 948 mg in 32.7 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1700 mg in 32.7 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE (UNII: NMQ347994Z) NYLON-12 (UNII: 446U8J075B) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) DIGLYCINE (UNII: 10525P22U0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) EDETATE DISODIUM (UNII: 7FLD91C86K) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIPROPYLENE GLYCOL (UNII: E107L85C40) BARIUM SULFATE (UNII: 25BB7EKE2E) SODIUM METABISULFITE (UNII: 4VON5FNS3C) METHICONE (20 CST) (UNII: 6777U11MKT) TETRADECENE (UNII: FW23481S7S) DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) BENZOIC ACID (UNII: 8SKN0B0MIM) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-113-10 1 in 1 CARTON 08/01/2013 1 32.7 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2013 SHISEIDO SHEER AND PERFECT FOUNDATION O20
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-114 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 948 mg in 32.7 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1700 mg in 32.7 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE (UNII: NMQ347994Z) NYLON-12 (UNII: 446U8J075B) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) DIGLYCINE (UNII: 10525P22U0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) EDETATE DISODIUM (UNII: 7FLD91C86K) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIPROPYLENE GLYCOL (UNII: E107L85C40) BARIUM SULFATE (UNII: 25BB7EKE2E) SODIUM METABISULFITE (UNII: 4VON5FNS3C) METHICONE (20 CST) (UNII: 6777U11MKT) TETRADECENE (UNII: FW23481S7S) DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) BENZOIC ACID (UNII: 8SKN0B0MIM) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-114-10 1 in 1 CARTON 08/01/2013 1 32.7 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2013 SHISEIDO SHEER AND PERFECT FOUNDATION O40
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-115 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 948 mg in 32.7 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1700 mg in 32.7 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE (UNII: NMQ347994Z) NYLON-12 (UNII: 446U8J075B) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) DIGLYCINE (UNII: 10525P22U0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) EDETATE DISODIUM (UNII: 7FLD91C86K) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIPROPYLENE GLYCOL (UNII: E107L85C40) BARIUM SULFATE (UNII: 25BB7EKE2E) SODIUM METABISULFITE (UNII: 4VON5FNS3C) METHICONE (20 CST) (UNII: 6777U11MKT) TETRADECENE (UNII: FW23481S7S) DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) BENZOIC ACID (UNII: 8SKN0B0MIM) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-115-10 1 in 1 CARTON 08/01/2013 1 32.7 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2013 SHISEIDO SHEER AND PERFECT FOUNDATION O60
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-116 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 948 mg in 32.7 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1700 mg in 32.7 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE (UNII: NMQ347994Z) NYLON-12 (UNII: 446U8J075B) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) DIGLYCINE (UNII: 10525P22U0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) EDETATE DISODIUM (UNII: 7FLD91C86K) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIPROPYLENE GLYCOL (UNII: E107L85C40) BARIUM SULFATE (UNII: 25BB7EKE2E) SODIUM METABISULFITE (UNII: 4VON5FNS3C) METHICONE (20 CST) (UNII: 6777U11MKT) TETRADECENE (UNII: FW23481S7S) DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) BENZOIC ACID (UNII: 8SKN0B0MIM) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-116-10 1 in 1 CARTON 08/01/2013 1 32.7 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2013 SHISEIDO SHEER AND PERFECT FOUNDATION O80
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-117 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 948 mg in 32.7 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1700 mg in 32.7 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE (UNII: NMQ347994Z) NYLON-12 (UNII: 446U8J075B) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) DIGLYCINE (UNII: 10525P22U0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) EDETATE DISODIUM (UNII: 7FLD91C86K) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIPROPYLENE GLYCOL (UNII: E107L85C40) BARIUM SULFATE (UNII: 25BB7EKE2E) SODIUM METABISULFITE (UNII: 4VON5FNS3C) METHICONE (20 CST) (UNII: 6777U11MKT) TETRADECENE (UNII: FW23481S7S) DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) BENZOIC ACID (UNII: 8SKN0B0MIM) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-117-10 1 in 1 CARTON 08/01/2013 1 32.7 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2013 SHISEIDO SHEER AND PERFECT FOUNDATION D10
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-118 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 948 mg in 32.7 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1700 mg in 32.7 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE (UNII: NMQ347994Z) NYLON-12 (UNII: 446U8J075B) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) DIGLYCINE (UNII: 10525P22U0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) EDETATE DISODIUM (UNII: 7FLD91C86K) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIPROPYLENE GLYCOL (UNII: E107L85C40) BARIUM SULFATE (UNII: 25BB7EKE2E) SODIUM METABISULFITE (UNII: 4VON5FNS3C) METHICONE (20 CST) (UNII: 6777U11MKT) TETRADECENE (UNII: FW23481S7S) DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) BENZOIC ACID (UNII: 8SKN0B0MIM) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-118-10 1 in 1 CARTON 08/01/2013 1 32.7 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2013 SHISEIDO SHEER AND PERFECT FOUNDATION D20
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-119 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 948 mg in 32.7 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1700 mg in 32.7 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE (UNII: NMQ347994Z) NYLON-12 (UNII: 446U8J075B) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) DIGLYCINE (UNII: 10525P22U0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) EDETATE DISODIUM (UNII: 7FLD91C86K) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIPROPYLENE GLYCOL (UNII: E107L85C40) BARIUM SULFATE (UNII: 25BB7EKE2E) SODIUM METABISULFITE (UNII: 4VON5FNS3C) METHICONE (20 CST) (UNII: 6777U11MKT) TETRADECENE (UNII: FW23481S7S) DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) BENZOIC ACID (UNII: 8SKN0B0MIM) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-119-10 1 in 1 CARTON 08/01/2013 1 32.7 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2013 SHISEIDO SHEER AND PERFECT FOUNDATION D30
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-120 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 948 mg in 32.7 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1700 mg in 32.7 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE (UNII: NMQ347994Z) NYLON-12 (UNII: 446U8J075B) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) DIGLYCINE (UNII: 10525P22U0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) EDETATE DISODIUM (UNII: 7FLD91C86K) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIPROPYLENE GLYCOL (UNII: E107L85C40) BARIUM SULFATE (UNII: 25BB7EKE2E) SODIUM METABISULFITE (UNII: 4VON5FNS3C) METHICONE (20 CST) (UNII: 6777U11MKT) TETRADECENE (UNII: FW23481S7S) DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) BENZOIC ACID (UNII: 8SKN0B0MIM) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-120-10 1 in 1 CARTON 08/01/2013 1 32.7 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2013 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 manufacture(58411-103, 58411-104, 58411-105, 58411-106, 58411-107, 58411-108, 58411-109, 58411-110, 58411-111, 58411-112, 58411-113, 58411-114, 58411-115, 58411-116, 58411-117, 58411-118, 58411-119, 58411-120) , analysis(58411-103, 58411-104, 58411-105, 58411-106, 58411-107, 58411-108, 58411-109, 58411-110, 58411-111, 58411-112, 58411-113, 58411-114, 58411-115, 58411-116, 58411-117, 58411-118, 58411-119, 58411-120)
