ATOMY SUNSCREEN

Product NDC
52257-1240
Requested package NDC
52257-1240-1
11-digit product format
522571240
Labeler code
52257
Product ID
52257-1240_fdcc92d8-f02f-4daa-8bd4-696c403c7b1c
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octisalate, Zinc Oxide, Titanium Dioxide
Dosage form
CREAM
Route
TOPICAL
Labeler
ATOMY CO., LTD.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-02-01
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE
Active strength
4 mg/60mL; mg/60mL; mg/60mL; mg/60mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52257-124052257-1240-1DDiscontinued by firm2026-10-05

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD51ATOMY SUNSCREEN WHITE BROAD SPECTRUM SPF50 PLUS (OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ATOMY CO., LTD.]2
OctisalateACTIVE INGREDIENT4X49Y0596WATOMY SUNSCREEN WHITE BROAD SPECTRUM SPF50 PLUS (OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ATOMY CO., LTD.]2
Titanium DioxideACTIVE INGREDIENT15FIX9V2JPATOMY SUNSCREEN WHITE BROAD SPECTRUM SPF50 PLUS (OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ATOMY CO., LTD.]2
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZATOMY SUNSCREEN WHITE BROAD SPECTRUM SPF50 PLUS (OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ATOMY CO., LTD.]2
OCTINOXATEACTIVE MOIETY4Y5P7MUD51ATOMY SUNSCREEN WHITE BROAD SPECTRUM SPF50 PLUS (OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ATOMY CO., LTD.]2
OCTISALATEACTIVE MOIETY4X49Y0596WATOMY SUNSCREEN WHITE BROAD SPECTRUM SPF50 PLUS (OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ATOMY CO., LTD.]2
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPATOMY SUNSCREEN WHITE BROAD SPECTRUM SPF50 PLUS (OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ATOMY CO., LTD.]2
ZINC CATIONACTIVE MOIETY13S1S8SF37ATOMY SUNSCREEN WHITE BROAD SPECTRUM SPF50 PLUS (OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ATOMY CO., LTD.]2
BUTYLOCTYL SALICYLATEINACTIVE INGREDIENT2EH13UN8D3ATOMY SUNSCREEN WHITE BROAD SPECTRUM SPF50 PLUS (OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ATOMY CO., LTD.]2
WATERINACTIVE INGREDIENT059QF0KO0RATOMY SUNSCREEN WHITE BROAD SPECTRUM SPF50 PLUS (OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ATOMY CO., LTD.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52257-1240-15225712400160 mL in 1 CARTON (52257-1240-1) 60 ml2013-02-010000-00-00NoNoCurrent