Label: SHISEIDO PERFECT REFINING FOUNDATION D10- octinoxate and titanium dioxide cream
SHISEIDO PERFECT REFINING FOUNDATION D20- octinoxate and titanium dioxide cream
SHISEIDO PERFECT REFINING FOUNDATION D30- octinoxate and titanium dioxide cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 52686-277-60, 52686-278-60, 52686-279-60 - Packager: SHISEIDO AMERICA INC.
- 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, NYLON-12, SD ALCOHOL 40-B, DIETHYLHEXYL SUCCINATE, GLYCERIN, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PEG-10 DIMETHICONE, ERYTHRITOL, XYLITOL, POLYGLYCERYL-2 DIISOSTEARATE, PEG/PPG-36/41 DIMETHYL ETHER, SODIUM HYALURONATE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, PAEONIA ALBIFLORA ROOT EXTRACT, ALUMINUM HYDROXIDE, ALUMINUM DISTEARATE, TRISODIUM EDTA, DISTEARDIMONIUM HECTORITE, POLYSILICONE-2, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, BUTYLENE GLYCOL, TOCOPHEROL, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE, BARIUM SULFATE, SODIUM METABISULFITE, BHT, METHICONE, TETRADECENE, HYDROGEN DIMETHICONE, ALUMINA, PHENOXYETHANOL, BENZOIC ACID, IRON OXIDES, ZINC OXIDE, MICA, TITANIUM DIOXIDE,
- Other information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30mL D 10 Tube Carton
- PRINCIPAL DISPLAY PANEL - 30mL D 20 Tube Carton
- PRINCIPAL DISPLAY PANEL - 30mL D 30 Tube Carton
-
INGREDIENTS AND APPEARANCE
SHISEIDO PERFECT REFINING FOUNDATION D10
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-277 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 983 mg in 33.9 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1966 mg in 33.9 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE (UNII: NMQ347994Z) NYLON-12 (UNII: 446U8J075B) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETATE TRISODIUM (UNII: 420IP921MB) PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F) HYALURONATE SODIUM (UNII: YSE9PPT4TH) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ZINC OXIDE (UNII: SOI2LOH54Z) MICA (UNII: V8A1AW0880) 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) ALUMINUM OXIDE (UNII: LMI26O6933) BENZOIC ACID (UNII: 8SKN0B0MIM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52686-277-60 1 in 1 CARTON 02/01/2011 1 33.9 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 D20
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-278 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 983 mg in 33.9 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1966 mg in 33.9 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE (UNII: NMQ347994Z) NYLON-12 (UNII: 446U8J075B) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETATE TRISODIUM (UNII: 420IP921MB) PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F) HYALURONATE SODIUM (UNII: YSE9PPT4TH) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ZINC OXIDE (UNII: SOI2LOH54Z) MICA (UNII: V8A1AW0880) 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) ALUMINUM OXIDE (UNII: LMI26O6933) BENZOIC ACID (UNII: 8SKN0B0MIM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52686-278-60 1 in 1 CARTON 02/01/2011 1 33.9 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 D30
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-279 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 983 mg in 33.9 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1966 mg in 33.9 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE (UNII: NMQ347994Z) NYLON-12 (UNII: 446U8J075B) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ERYTHRITOL (UNII: RA96B954X6) XYLITOL (UNII: VCQ006KQ1E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETATE TRISODIUM (UNII: 420IP921MB) PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F) HYALURONATE SODIUM (UNII: YSE9PPT4TH) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ZINC OXIDE (UNII: SOI2LOH54Z) MICA (UNII: V8A1AW0880) 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) ALUMINUM OXIDE (UNII: LMI26O6933) BENZOIC ACID (UNII: 8SKN0B0MIM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52686-279-60 1 in 1 CARTON 02/01/2011 1 33.9 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(52686-277, 52686-278, 52686-279) , analysis(52686-277, 52686-278, 52686-279)