Label: SHISEIDO REFINING MAKEUP PRIMER- octinoxate and titanium dioxide emulsion
- NDC Code(s): 58411-630-10
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated February 25, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
- Directions
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Inactive Ingredients
CYCLOMETHICONE • WATER • DIPROPYLENE GLYCOL • SILICA • GLYCERIN • POLYMETHYLSILSESQUIOXANE • POLYMETHYL METHACRYLATE • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER • PEG-10 DIMETHICONE • DISTEARDIMONIUM HECTORITE • TRIMETHYLSILOXYSILICATE • PEG/PPG-36/41 DIMETHYL ETHER • LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL • ALUMINUM DISTEARATE • ALUMINUM HYDROXIDE • ISOSTEARIC ACID • TRISODIUM EDTA • DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE • POLYSILICONE-2 • BHT • TOCOPHEROL • METHICONE • TETRADECENE • PHENOXYETHANOL • IRON OXIDES • MICA • TITANIUM DIOXIDE
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- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
SHISEIDO REFINING MAKEUP PRIMER
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-630 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.69 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.53 g in 30 mL Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE (UNII: NMQ347994Z) WATER (UNII: 059QF0KO0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F) LAVENDER OIL (UNII: ZBP1YXW0H8) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ISOSTEARIC ACID (UNII: X33R8U0062) EDETATE TRISODIUM (UNII: 420IP921MB) DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) METHICONE (20 CST) (UNII: 6777U11MKT) 1-TETRADECENE (UNII: FW23481S7S) PHENOXYETHANOL (UNII: HIE492ZZ3T) 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:58411-630-10 1 in 1 CARTON 01/01/2021 1 30 mL 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 FINAL part352 01/01/2021 Labeler - SHISEIDO AMERICAS CORPORATION (193691821)