Label: SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) I00- octinoxate and titanium dioxide powder
SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) I20- octinoxate and titanium dioxide powder
SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) I40- octinoxate and titanium dioxide powder
SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) I60- octinoxate and titanium dioxide powder
SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) B20- octinoxate and titanium dioxide powder
SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) B40- octinoxate and titanium dioxide powder
SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) B60- octinoxate and titanium dioxide powder
SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) O20- octinoxate and titanium dioxide powder
SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) O40- octinoxate and titanium dioxide powder
SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) O60- octinoxate and titanium dioxide powder
SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) O80- octinoxate and titanium dioxide powder
-
NDC Code(s):
52685-433-30,
52685-434-30,
52685-435-30,
52685-436-30, view more52685-437-30, 52685-438-30, 52685-439-30, 52685-440-30, 52685-441-30, 52685-442-30, 52685-443-30
- Packager: SHISEIDO CO., LTD.
- 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 13, 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
BARIUM SULFATE • TALC • TITANIUM DIOXIDE • MICA • VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER • SYNTHETIC FLUORPHLOGOPITE • IRON OXIDES • ZINC MYRISTATE • DIMETHICONE • BORON NITRIDE • DIISOSTEARYL MALATE • PETROLATUM • SQUALANE • ZINC OXIDE • SORBITAN SESQUIISOSTEARATE • POLYSILICONE-2 • ALUMINUM HYDROXIDE • ALUMINUM DISTEARATE • ETHYLHEXYLGLYCERIN • PEG/PPG-36/41 DIMETHYL ETHER • ALCOHOL • WATER • TOCOPHEROL • POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE • FRAGRANCE • PHENOXYETHANOL • ALUMINA • BHT • ROYAL JELLY EXTRACT
- Other information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 10g Tray Carton (I 00)
- PRINCIPAL DISPLAY PANEL - 10g Tray Carton (I 20)
- PRINCIPAL DISPLAY PANEL - 10g Tray Carton (I 40)
- PRINCIPAL DISPLAY PANEL - 10g Tray Carton (I 60)
- PRINCIPAL DISPLAY PANEL - 10g Tray Carton (B 20)
- PRINCIPAL DISPLAY PANEL - 10g Tray Carton (B 40)
- PRINCIPAL DISPLAY PANEL - 10g Tray Carton (B 60)
- PRINCIPAL DISPLAY PANEL - 10g Tray Carton (O 20)
- PRINCIPAL DISPLAY PANEL - 10g Tray Carton (O 40)
- PRINCIPAL DISPLAY PANEL - 10g Tray Carton (O 60)
- PRINCIPAL DISPLAY PANEL - 10g Tray Carton (O 80)
-
INGREDIENTS AND APPEARANCE
SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) I00
octinoxate and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52685-433 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 140 mg in 10 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 250 mg in 10 g Inactive Ingredients Ingredient Name Strength BARIUM SULFATE (UNII: 25BB7EKE2E) TALC (UNII: 7SEV7J4R1U) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ZINC MYRISTATE (UNII: K09A9E2GGO) DIMETHICONE (UNII: 92RU3N3Y1O) BORON NITRIDE (UNII: 2U4T60A6YD) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PETROLATUM (UNII: 4T6H12BN9U) SQUALANE (UNII: GW89575KF9) ZINC OXIDE (UNII: SOI2LOH54Z) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ROYAL JELLY (UNII: L497I37F0C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52685-433-30 1 in 1 CARTON 09/01/2008 1 10 g in 1 TRAY; 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 09/01/2008 SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) I20
octinoxate and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52685-434 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 140 mg in 10 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 250 mg in 10 g Inactive Ingredients Ingredient Name Strength BARIUM SULFATE (UNII: 25BB7EKE2E) TALC (UNII: 7SEV7J4R1U) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ZINC MYRISTATE (UNII: K09A9E2GGO) DIMETHICONE (UNII: 92RU3N3Y1O) BORON NITRIDE (UNII: 2U4T60A6YD) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PETROLATUM (UNII: 4T6H12BN9U) SQUALANE (UNII: GW89575KF9) ZINC OXIDE (UNII: SOI2LOH54Z) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ROYAL JELLY (UNII: L497I37F0C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52685-434-30 1 in 1 CARTON 09/01/2008 1 10 g in 1 TRAY; 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 09/01/2008 SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) I40
octinoxate and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52685-435 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 140 mg in 10 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 250 mg in 10 g Inactive Ingredients Ingredient Name Strength BARIUM SULFATE (UNII: 25BB7EKE2E) TALC (UNII: 7SEV7J4R1U) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ZINC MYRISTATE (UNII: K09A9E2GGO) DIMETHICONE (UNII: 92RU3N3Y1O) BORON NITRIDE (UNII: 2U4T60A6YD) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PETROLATUM (UNII: 4T6H12BN9U) SQUALANE (UNII: GW89575KF9) ZINC OXIDE (UNII: SOI2LOH54Z) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ROYAL JELLY (UNII: L497I37F0C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52685-435-30 1 in 1 CARTON 09/01/2008 1 10 g in 1 TRAY; 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 09/01/2008 SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) I60
octinoxate and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52685-436 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 140 mg in 10 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 250 mg in 10 g Inactive Ingredients Ingredient Name Strength BARIUM SULFATE (UNII: 25BB7EKE2E) TALC (UNII: 7SEV7J4R1U) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ZINC MYRISTATE (UNII: K09A9E2GGO) DIMETHICONE (UNII: 92RU3N3Y1O) BORON NITRIDE (UNII: 2U4T60A6YD) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PETROLATUM (UNII: 4T6H12BN9U) SQUALANE (UNII: GW89575KF9) ZINC OXIDE (UNII: SOI2LOH54Z) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ROYAL JELLY (UNII: L497I37F0C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52685-436-30 1 in 1 CARTON 09/01/2008 1 10 g in 1 TRAY; 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 09/01/2008 SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) B20
octinoxate and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52685-437 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 140 mg in 10 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 250 mg in 10 g Inactive Ingredients Ingredient Name Strength BARIUM SULFATE (UNII: 25BB7EKE2E) TALC (UNII: 7SEV7J4R1U) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ZINC MYRISTATE (UNII: K09A9E2GGO) DIMETHICONE (UNII: 92RU3N3Y1O) BORON NITRIDE (UNII: 2U4T60A6YD) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PETROLATUM (UNII: 4T6H12BN9U) SQUALANE (UNII: GW89575KF9) ZINC OXIDE (UNII: SOI2LOH54Z) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ROYAL JELLY (UNII: L497I37F0C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52685-437-30 1 in 1 CARTON 09/01/2008 1 10 g in 1 TRAY; 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 09/01/2008 SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) B40
octinoxate and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52685-438 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 140 mg in 10 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 250 mg in 10 g Inactive Ingredients Ingredient Name Strength BARIUM SULFATE (UNII: 25BB7EKE2E) TALC (UNII: 7SEV7J4R1U) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ZINC MYRISTATE (UNII: K09A9E2GGO) DIMETHICONE (UNII: 92RU3N3Y1O) BORON NITRIDE (UNII: 2U4T60A6YD) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PETROLATUM (UNII: 4T6H12BN9U) SQUALANE (UNII: GW89575KF9) ZINC OXIDE (UNII: SOI2LOH54Z) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ROYAL JELLY (UNII: L497I37F0C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52685-438-30 1 in 1 CARTON 09/01/2008 1 10 g in 1 TRAY; 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 09/01/2008 SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) B60
octinoxate and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52685-439 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 140 mg in 10 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 250 mg in 10 g Inactive Ingredients Ingredient Name Strength BARIUM SULFATE (UNII: 25BB7EKE2E) TALC (UNII: 7SEV7J4R1U) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ZINC MYRISTATE (UNII: K09A9E2GGO) DIMETHICONE (UNII: 92RU3N3Y1O) BORON NITRIDE (UNII: 2U4T60A6YD) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PETROLATUM (UNII: 4T6H12BN9U) SQUALANE (UNII: GW89575KF9) ZINC OXIDE (UNII: SOI2LOH54Z) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ROYAL JELLY (UNII: L497I37F0C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52685-439-30 1 in 1 CARTON 09/01/2008 1 10 g in 1 TRAY; 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 09/01/2008 SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) O20
octinoxate and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52685-440 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 140 mg in 10 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 250 mg in 10 g Inactive Ingredients Ingredient Name Strength BARIUM SULFATE (UNII: 25BB7EKE2E) TALC (UNII: 7SEV7J4R1U) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ZINC MYRISTATE (UNII: K09A9E2GGO) DIMETHICONE (UNII: 92RU3N3Y1O) BORON NITRIDE (UNII: 2U4T60A6YD) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PETROLATUM (UNII: 4T6H12BN9U) SQUALANE (UNII: GW89575KF9) ZINC OXIDE (UNII: SOI2LOH54Z) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ROYAL JELLY (UNII: L497I37F0C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52685-440-30 1 in 1 CARTON 09/01/2008 1 10 g in 1 TRAY; 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 09/01/2008 SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) O40
octinoxate and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52685-441 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 140 mg in 10 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 250 mg in 10 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) SQUALANE (UNII: GW89575KF9) ZINC OXIDE (UNII: SOI2LOH54Z) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ROYAL JELLY (UNII: L497I37F0C) BARIUM SULFATE (UNII: 25BB7EKE2E) TALC (UNII: 7SEV7J4R1U) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ZINC MYRISTATE (UNII: K09A9E2GGO) DIMETHICONE (UNII: 92RU3N3Y1O) BORON NITRIDE (UNII: 2U4T60A6YD) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52685-441-30 1 in 1 CARTON 09/01/2008 1 10 g in 1 TRAY; 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 09/01/2008 SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) O60
octinoxate and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52685-442 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 140 mg in 10 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 250 mg in 10 g Inactive Ingredients Ingredient Name Strength BARIUM SULFATE (UNII: 25BB7EKE2E) TALC (UNII: 7SEV7J4R1U) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ZINC MYRISTATE (UNII: K09A9E2GGO) DIMETHICONE (UNII: 92RU3N3Y1O) BORON NITRIDE (UNII: 2U4T60A6YD) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PETROLATUM (UNII: 4T6H12BN9U) SQUALANE (UNII: GW89575KF9) ZINC OXIDE (UNII: SOI2LOH54Z) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ROYAL JELLY (UNII: L497I37F0C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52685-442-30 1 in 1 CARTON 09/01/2008 1 10 g in 1 TRAY; 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 09/01/2008 SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) O80
octinoxate and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52685-443 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 140 mg in 10 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 250 mg in 10 g Inactive Ingredients Ingredient Name Strength BARIUM SULFATE (UNII: 25BB7EKE2E) TALC (UNII: 7SEV7J4R1U) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ZINC MYRISTATE (UNII: K09A9E2GGO) DIMETHICONE (UNII: 92RU3N3Y1O) BORON NITRIDE (UNII: 2U4T60A6YD) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PETROLATUM (UNII: 4T6H12BN9U) SQUALANE (UNII: GW89575KF9) ZINC OXIDE (UNII: SOI2LOH54Z) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ROYAL JELLY (UNII: L497I37F0C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52685-443-30 1 in 1 CARTON 09/01/2008 1 10 g in 1 TRAY; 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 09/01/2008 Labeler - SHISEIDO CO., LTD. (690536453) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 manufacture(52685-433, 52685-434, 52685-435, 52685-436, 52685-437, 52685-438, 52685-439, 52685-440, 52685-441, 52685-442, 52685-443) , analysis(52685-433, 52685-434, 52685-435, 52685-436, 52685-437, 52685-438, 52685-439, 52685-440, 52685-441, 52685-442, 52685-443)