Label: SHISEIDO ULTIMATE SUN PROTECTOR- octisalate, titanium dioxide, octocrylene, and zinc oxide cream
- NDC Code(s): 58411-480-60
- 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 October 17, 2019
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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
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Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every two 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▪DIMETHICONE▪SD ALCOHOL 40-B▪ISOPROPYL MYRISTATE▪PEG/PPG-9/2 DIMETHYL ETHER▪METHYL METHACRYLATE CROSSPOLYMER▪LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE▪GLYCERIN▪ISOHEXADECANE▪POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER▪ISODODECANE▪TRIMETHYLSILOXYSILICATE▪DISTEARDIMONIUM HECTORITE▪DEXTRIN PALMITATE▪PEG/PPG-14/7 DIMETHYL ETHER▪SAXIFRAGA SARMENTOSA EXTRACT▪SCUTELLARIA BAICALENSIS ROOT EXTRACT▪CAMELLIA SINENSIS LEAF EXTRACT▪ONONIS SPINOSA ROOT EXTRACT▪SODIUM HYALURONATE▪SOPHORA ANGUSTIFOLIA ROOT EXTRACT▪ALUMINUM HYDROXIDE▪SILICA▪HYDROGEN DIMETHICONE▪STEARIC ACID▪SORBITAN SESQUIISOSTEARATE▪CARBOXYDECYL TRISILOXANE▪TRISODIUM EDTA▪BUTYLENE GLYCOL▪ALCOHOL▪POLYMETHYLSILSESQUIOXANE▪TALC▪TOCOPHEROL▪BHT▪SODIUM METABISULFITE▪PEG-6▪SYZYGIUM JAMBOS LEAF EXTRACT▪PHENOXYETHANOL▪FRAGRANCE▪
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Label
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INGREDIENTS AND APPEARANCE
SHISEIDO ULTIMATE SUN PROTECTOR
octisalate, titanium dioxide, octocrylene, and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-480 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3.105 g in 50 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.359 g in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 4.347 g in 50 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 12.047 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PEG/PPG-9/2 DIMETHYL ETHER (UNII: LM6Q66468X) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) ISODODECANE (UNII: A8289P68Y2) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ONONIS SPINOSA ROOT (UNII: FD2FMC53M1) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) STEARIC ACID (UNII: 4ELV7Z65AP) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALCOHOL (UNII: 3K9958V90M) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) TALC (UNII: 7SEV7J4R1U) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) .ALPHA.-CELLULOSE (UNII: I355QGZ19A) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-480-60 1 in 1 CARTON 01/01/2020 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 01/01/2020 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICAS INC. 782677132 MANUFACTURE(58411-480) , ANALYSIS(58411-480)
