Home NDC 52686-335 SHISEIDO SUN PROTECTION EYE
Product NDC 52686-335
11-digit product format 526860335
Labeler code 52686
Product ID 52686-335_7cf01061-59fb-9400-e053-2991aa0aba4f
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler SHISEIDO AMERICA INC.
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2012-12-01
Marketing end 0000-00-00
Substance OCTINOXATE; OCTOCRYLENE; ZINC OXIDE
Active strength 479 mg/16.5g; mg/16.5g; mg/16.5g
NDC exclude flag No
Listing certified through 2019-12-31
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 · 33 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 52686-335-60 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 52686-335-60 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 52686-335-60 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 52686-335-60 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 52686-335-60 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 52686-335-60 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 52686-335-60 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 52686-335-60 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 52686-335-60 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 52686-335-60 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 52686-335-60 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 52686-335-60 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 52686-335-60 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 52686-335-60 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 52686-335-60 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 52686-335-60 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 52686-335-60 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 52686-335-60 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52686-335-60 SHISEIDO SUN PROTECTION EYE 1 in 1 CARTON CREAM 1 4 52686-335-60 SHISEIDO SUN PROTECTION EYE 16.5 g in 1 TUBE CREAM 16.5 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 ZINC OXIDE ACTIVE MOIETY SOI2LOH54Z SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 .ALPHA.-TOCOPHEROL INACTIVE INGREDIENT H4N855PNZ1 SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 .ALPHA.-TOCOPHEROL ACETATE, DL- INACTIVE INGREDIENT WR1WPI7EW8 SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 BUTYLENE GLYCOL INACTIVE INGREDIENT 3XUS85K0RA SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 DIPROPYLENE GLYCOL INACTIVE INGREDIENT E107L85C40 SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 ECTOINE INACTIVE INGREDIENT 7GXZ3858RY SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 EDETATE TRISODIUM INACTIVE INGREDIENT 420IP921MB SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 GLYCYRRHIZINATE DIPOTASSIUM INACTIVE INGREDIENT CA2Y0FE3FX SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 ISODODECANE INACTIVE INGREDIENT A8289P68Y2 SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 ISOHEXADECANE INACTIVE INGREDIENT 918X1OUF1E SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 ISOSTEARIC ACID INACTIVE INGREDIENT X33R8U0062 SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 METHYL GLUCETH-10 INACTIVE INGREDIENT N0MWT4C7WH SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 ONONIS SPINOSA ROOT INACTIVE INGREDIENT FD2FMC53M1 SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 PEG/PPG-14/7 DIMETHYL ETHER INACTIVE INGREDIENT 6DNW9T7YT2 SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 SCUTELLARIA BAICALENSIS ROOT INACTIVE INGREDIENT 7J95K7ID2S SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 SOPHORA FLAVESCENS ROOT INACTIVE INGREDIENT IYR6K8KQ5K SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 SYZYGIUM JAMBOS LEAF INACTIVE INGREDIENT 407Z4W5LFF SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 TRIETHOXYCAPRYLYLSILANE INACTIVE INGREDIENT LDC331P08E SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) INACTIVE INGREDIENT 5041RX63GN SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2 ZINC MYRISTATE INACTIVE INGREDIENT K09A9E2GGO SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52686-335 SHISEIDO SUN PROTECTION EYE (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.] 4 Legacy NDC, 2 package rows 20231228_5b3cc278-efaa-4adc-a5fb-9833243d2c0d.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 52686-335-60 52686033560 1 in 1 CARTON Historical