Home NDC 58411-253-10 SHISEIDO ULTIMATE SUN PROTECTION
Product NDC 58411-253
Requested package NDC 58411-253-10
11-digit product format 584110253
Labeler code 58411
Product ID 58411-253_934d88e8-7244-49f9-b0e1-419f4d2ab0d2
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, and ZINC OXIDE
Dosage form LOTION
Route TOPICAL
Labeler SHISEIDO AMERICAS CORPORATION
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2015-02-01
Marketing end 0000-00-00
Substance OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength 8406 mg/100mL; mg/100mL; mg/100mL; mg/100mL
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 TITANIUM DIOXIDE ACTIVE INGREDIENT 15FIX9V2JP SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 TITANIUM DIOXIDE ACTIVE MOIETY 15FIX9V2JP SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 ZINC OXIDE ACTIVE MOIETY SOI2LOH54Z SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 .ALPHA.-TOCOPHEROL INACTIVE INGREDIENT H4N855PNZ1 SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 ALUMINUM HYDROXIDE INACTIVE INGREDIENT 5QB0T2IUN0 SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 BUTYLENE GLYCOL INACTIVE INGREDIENT 3XUS85K0RA SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 DISTEARDIMONIUM HECTORITE INACTIVE INGREDIENT X687XDK09L SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 ECTOINE INACTIVE INGREDIENT 7GXZ3858RY SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 EDETATE TRISODIUM INACTIVE INGREDIENT 420IP921MB SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 HYDROGENATED POLYDECENE (550 MW) INACTIVE INGREDIENT U333RI6EB7 SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 ISODODECANE INACTIVE INGREDIENT A8289P68Y2 SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 ISOHEXADECANE INACTIVE INGREDIENT 918X1OUF1E SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 ISOSTEARIC ACID INACTIVE INGREDIENT X33R8U0062 SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 METHYL GLUCETH-10 INACTIVE INGREDIENT N0MWT4C7WH SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE INACTIVE INGREDIENT TYP81E471F SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 PEG/PPG-14/7 DIMETHYL ETHER INACTIVE INGREDIENT 6DNW9T7YT2 SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) INACTIVE INGREDIENT 59Z907ZB69 SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 SAXIFRAGA STOLONIFERA LEAF INACTIVE INGREDIENT O3TMV4903H SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 SCUTELLARIA BAICALENSIS ROOT INACTIVE INGREDIENT 7J95K7ID2S SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 SOPHORA FLAVESCENS ROOT INACTIVE INGREDIENT IYR6K8KQ5K SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 SYZYGIUM JAMBOS LEAF INACTIVE INGREDIENT 407Z4W5LFF SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) INACTIVE INGREDIENT 5041RX63GN SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 58411-253-10 58411025310 1 BOTTLE, PLASTIC in 1 CARTON (58411-253-10) > 100 mL in 1 BOTTLE, PLASTIC 2015-02-01 0000-00-00 No No Current