Label: SHISEIDO ULTIMATE SUN PROTECTION- octinoxate, octocrylene, titanium dioxide, and zinc oxide lotion
- NDC Code(s): 58411-253-10, 58411-253-80
- Packager: SHISEIDO AMERICAS CORPORATION
- 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 June 19, 2020
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
-
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
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 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•BUTYLENE GLYCOL•ISOPROPYL MYRISTATE•ISOHEXADECANE•SD ALCOHOL 40-B•ISODODECANE•METHYL METHACRYLATE CROSSPOLYMER•PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE•TRIMETHYLSILOXYSILICATE•POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER•XYLITOL•GLYCERIN•METHYL GLUCETH-10•PEG/PPG-14/7 DIMETHYL ETHER•SAXIFRAGA SARMENTOSA EXTRACT•SCUTELLARIA BAICALENSIS ROOT EXTRACT•ECTOIN•SOPHORA ANGUSTIFOLIA ROOT EXTRACT•HYDROGENATED POLYDECENE•HYDROGEN DIMETHICONE•ISOSTEARIC ACID•DEXTRIN PALMITATE•ALUMINUM HYDROXIDE•STEARIC ACID•DISTEARDIMONIUM HECTORITE•SILICA•POLYMETHYLSILSESQUIOXANE•TALC•ALCOHOL•TRISODIUM EDTA•BHT•SYZYGIUM JAMBOS LEAF EXTRACT•TOCOPHEROL•FRAGRANCE•
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton
-
INGREDIENTS AND APPEARANCE
SHISEIDO ULTIMATE SUN PROTECTION
octinoxate, octocrylene, titanium dioxide, and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-253 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 8406 mg in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 3408 mg in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1590 mg in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 18630 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ISOHEXADECANE (UNII: 918X1OUF1E) ISODODECANE (UNII: A8289P68Y2) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) XYLITOL (UNII: VCQ006KQ1E) GLYCERIN (UNII: PDC6A3C0OX) METHYL GLUCETH-10 (UNII: N0MWT4C7WH) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) ECTOINE (UNII: 7GXZ3858RY) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) ISOSTEARIC ACID (UNII: X33R8U0062) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) TALC (UNII: 7SEV7J4R1U) ALCOHOL (UNII: 3K9958V90M) EDETATE TRISODIUM (UNII: 420IP921MB) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-253-10 1 in 1 CARTON 02/01/2015 1 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:58411-253-80 2 mL in 1 POUCH; Type 0: Not a Combination Product 02/01/2015 12/31/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2015 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 manufacture(58411-253) , analysis(58411-253)
