ATOMY SUNSCREEN

Product NDC
52257-1240
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52257-1240DDiscontinued by firm2026-10-05
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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52257-1240-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52257-1240-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52257-1240-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52257-1240-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52257-1240-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52257-1240-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52257-1240-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52257-1240-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52257-1240-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52257-1240-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52257-1240-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52257-1240-1557ba5c1ecfa…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