Label: SHISEIDO WASO COLOR-SMART DAY MOISTURIZER OIL-FREE- octinoxate and titanium dioxide emulsion
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Contains inactivated NDC Code(s)
NDC Code(s): 58411-457-60 - Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 November 27, 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
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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
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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
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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
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Inactive Ingredients
WATER∙CYCLOPENTASILOXANE∙SD ALCOHOL 40-B GLYCERIN∙METHYL METHACRYLATE CROSSPOLYMER∙DIMETHICONE∙PEG-10 DIMETHICONE∙POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER∙LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE∙POLYMETHYLSILSESQUIOXANE∙TALC∙ERYTHRITOL∙SILICA∙TREHALOSE∙DISTEARDIMONIUM HECTORITE∙TRIMETHYLSILOXYSILICATE∙CAFFEINE∙BETAINE∙PEG/PPG-17/4 DIMETHYL ETHER∙PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE∙DIPEPTIDE-15∙ERIOBOTRYA JAPONICA LEAF PROTOPLASTS∙PAEONIA ALBIFLORA ROOT EXTRACT∙LAMIUM ALBUM FLOWER/LEAF/STEM EXTRACT∙CITRUS JUNOS SEED EXTRACT∙ERIOBOTRYA JAPONICA LEAF EXTRACT∙ALUMINUM HYDROXIDE∙STEARIC ACID ISOSTEARIC ACID∙BUTYLENE GLYCOL∙TRISODIUM EDTA∙POLYESTER-1 ALCOHOL∙SILICA DIMETHYL SILYLATE∙ALUMINA∙TRIETHOXYCAPRYLYLSILANE HYDROGEN DIMETHICONE∙BHT∙TOCOPHEROL∙PHENOXYETHANOL∙BENZOIC ACID∙FRAGRANCE TITANIUM DIOXIDE IRON OXIDES MICA∙
- Other Information
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
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INGREDIENTS AND APPEARANCE
SHISEIDO WASO COLOR-SMART DAY MOISTURIZER OIL-FREE
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-457 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4177 mg in 50 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2992 mg in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT) DIMETHICONE (UNII: 92RU3N3Y1O) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) TALC (UNII: 7SEV7J4R1U) ERYTHRITOL (UNII: RA96B954X6) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TREHALOSE (UNII: B8WCK70T7I) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) CAFFEINE (UNII: 3G6A5W338E) BETAINE (UNII: 3SCV180C9W) PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K) PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q) DIGLYCINE (UNII: 10525P22U0) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) LAMIUM ALBUM FLOWERING TOP (UNII: T95771X2XI) CITRUS JUNOS SEED (UNII: UY43O1Q45N) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) ISOSTEARIC ACID (UNII: X33R8U0062) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) EDETATE TRISODIUM (UNII: 420IP921MB) ALCOHOL (UNII: 3K9958V90M) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) ALUMINUM OXIDE (UNII: LMI26O6933) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) PHENOXYETHANOL (UNII: HIE492ZZ3T) 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:58411-457-60 1 in 1 CARTON 02/01/2019 1 50 mL 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 FINAL part352 02/01/2019 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 MANUFACTURE(58411-457) , ANALYSIS(58411-457)
