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 more52686-236-60, 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.
- 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, 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
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 30mL B 00 Tube Carton
- PRINCIPAL DISPLAY PANEL - 30mL B 20 Tube Carton
- PRINCIPAL DISPLAY PANEL - 30mL B 40 Tube Carton
- PRINCIPAL DISPLAY PANEL - 30mL B 60 Tube Carton
- PRINCIPAL DISPLAY PANEL - 30mL B 100 Tube Carton
- PRINCIPAL DISPLAY PANEL - 30mL I 00 Tube Carton
- PRINCIPAL DISPLAY PANEL - 30mL I 20 Tube Carton
- PRINCIPAL DISPLAY PANEL - 30mL I 40 Tube Carton
- PRINCIPAL DISPLAY PANEL - 30mL I 60 Tube Carton
- PRINCIPAL DISPLAY PANEL - 30mL I 100 Tube Carton
- PRINCIPAL DISPLAY PANEL - 30mL O 00 Tube Carton
- PRINCIPAL DISPLAY PANEL - 30mL O 20 Tube Carton
- PRINCIPAL DISPLAY PANEL - 30mL O 40 Tube Carton
- PRINCIPAL DISPLAY PANEL - 30mL O 60 Tube Carton
- PRINCIPAL DISPLAY PANEL - 30mL O 80 Tube Carton
-
INGREDIENTS AND APPEARANCE
SHISEIDO PERFECT REFINING FOUNDATION I00
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-232 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.63555 g in 33.45 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.37145 g in 33.45 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:52686-232-60 1 in 1 CARTON 02/01/2011 1 33.45 g in 1 TUBE; 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 02/01/2011 SHISEIDO PERFECT REFINING FOUNDATION I20
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-233 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.63555 g in 33.45 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.37145 g in 33.45 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:52686-233-60 1 in 1 CARTON 02/01/2011 1 33.45 g in 1 TUBE; 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 02/01/2011 SHISEIDO PERFECT REFINING FOUNDATION I40
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-234 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.63555 g in 33.45 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.37145 g in 33.45 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:52686-234-60 1 in 1 CARTON 02/01/2011 1 33.45 g in 1 TUBE; 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 02/01/2011 SHISEIDO PERFECT REFINING FOUNDATION I60
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-235 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.63555 g in 33.45 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.37145 g in 33.45 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:52686-235-60 1 in 1 CARTON 02/01/2011 1 33.45 g in 1 TUBE; 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 02/01/2011 SHISEIDO PERFECT REFINING FOUNDATION I100
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-236 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.63555 g in 33.45 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.37145 g in 33.45 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:52686-236-60 1 in 1 CARTON 02/01/2011 1 33.45 g in 1 TUBE; 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 02/01/2011 SHISEIDO PERFECT REFINING FOUNDATION B00
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-237 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.63555 g in 33.45 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.37145 g in 33.45 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:52686-237-60 1 in 1 CARTON 02/01/2011 1 33.45 g in 1 TUBE; 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 02/01/2011 SHISEIDO PERFECT REFINING FOUNDATION B20
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-238 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.63555 g in 33.45 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.37145 g in 33.45 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:52686-238-60 1 in 1 CARTON 02/01/2011 1 33.45 g in 1 TUBE; 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 02/01/2011 SHISEIDO PERFECT REFINING FOUNDATION B40
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-239 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.63555 g in 33.45 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.37145 g in 33.45 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:52686-239-60 1 in 1 CARTON 02/01/2011 1 33.45 g in 1 TUBE; 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 02/01/2011 SHISEIDO PERFECT REFINING FOUNDATION B60
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-240 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.63555 g in 33.45 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.37145 g in 33.45 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:52686-240-60 1 in 1 CARTON 02/01/2011 1 33.45 g in 1 TUBE; 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 02/01/2011 SHISEIDO PERFECT REFINING FOUNDATION B100
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-241 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.63555 g in 33.45 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.37145 g in 33.45 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:52686-241-60 1 in 1 CARTON 02/01/2011 1 33.45 g in 1 TUBE; 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 02/01/2011 SHISEIDO PERFECT REFINING FOUNDATION O00
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-242 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.63555 g in 33.45 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.37145 g in 33.45 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:52686-242-60 1 in 1 CARTON 02/01/2011 1 33.45 g in 1 TUBE; 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 02/01/2011 SHISEIDO PERFECT REFINING FOUNDATION O20
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-243 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.63555 g in 33.45 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.37145 g in 33.45 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:52686-243-60 1 in 1 CARTON 02/01/2011 1 33.45 g in 1 TUBE; 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 02/01/2011 SHISEIDO PERFECT REFINING FOUNDATION O40
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-244 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.63555 g in 33.45 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.37145 g in 33.45 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:52686-244-60 1 in 1 CARTON 02/01/2011 1 33.45 g in 1 TUBE; 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 02/01/2011 SHISEIDO PERFECT REFINING FOUNDATION O60
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-245 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.63555 g in 33.45 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.37145 g in 33.45 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:52686-245-60 1 in 1 CARTON 02/01/2011 1 33.45 g in 1 TUBE; 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 02/01/2011 SHISEIDO PERFECT REFINING FOUNDATION O80
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-246 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.63555 g in 33.45 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.37145 g in 33.45 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:52686-246-60 1 in 1 CARTON 02/01/2011 1 33.45 g in 1 TUBE; 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 02/01/2011 Labeler - SHISEIDO AMERICA INC. (782677132) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 manufacture(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)