FDA.reportPublic FDA data

Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUS

Product NDC
52257-1420
11-digit product format
522571420
Labeler code
52257
Product ID
52257-1420_53422040-2fac-e1fd-e063-6294a90a328b
Type
HUMAN OTC DRUG
Nonproprietary name
HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
ATOMY CO., LTD.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-01
Substance
HOMOSALATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength
4.5; 2.7; 1.32; 7.62 g/60mL; g/60mL; g/60mL; g/60mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52257-1420-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52257-1420-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52257-1420-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52257-1420-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52257-1420-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52257-1420-11332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE4.5 g/60mL
OCTISALATE2.7 g/60mL
TITANIUM DIOXIDE1.32 g/60mL
ZINC OXIDE7.62 g/60mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
994d5680-284e-4faf-a29b-4d28f8d46e8fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-12-03994d5680-284e-4faf-a29b-4d28f8d46e8f
2024-12-03994d5680-284e-4faf-a29b-4d28f8d46e8f
2024-01-30994d5680-284e-4faf-a29b-4d28f8d46e8f
2024-01-30994d5680-284e-4faf-a29b-4d28f8d46e8f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52257-1420-1Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUS60 mL in 1 CARTONCREAM603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52257-1420ATOMY SUNSCREEN BEIGE BROAD SPECTRUM SPF 50 PLUS (HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ATOMY CO., LTD.]3Current NDC, Legacy NDC, 1 package rows20241205_994d5680-284e-4faf-a29b-4d28f8d46e8f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 62 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e.l.f. Wake the E.L.F. Up Skincare SetAVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATEe.l.f. Cosmetics, Inc4b20c56a-3e91-3419-e063-6294a90ad3612026-02-18WarningsExact identifier
application number: M020
Dermatone Mineral SPF 30ZINC OXIDE 20%Dermatone Labs LLC26e3209f-cb5c-484e-9b2e-74dc397d47902026-02-18WarningsExact identifier
application number: M020
SHISEIDO ESSENTIAL ENERGY HYDRATING DAYHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONESHISEIDO AMERICAS CORPORATION8b88039a-09fe-458b-b80f-49cde49b65952026-02-17WarningsExact identifier
application number: M020
cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED nAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONf3729d0b-e601-48bb-9907-1d6e3ab319962026-02-17WarningsExact identifier
application number: M020
Luminesce Daily Moisturizing ComplexAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEVelovita Inc.4b0c2213-8667-be6f-e063-6394a90a5e862026-02-17WarningsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEValu Merchandisers Companye168f8e8-22d0-4a60-b9f9-dec9d0fab3f12026-02-16Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen for Kids SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEValu Merchandisers Companycfc3b202-6511-450a-b3c1-2d8e8ebc070d2026-02-16Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEValu Merchandisers Company5a8af0ea-b31c-456a-bc23-31e2473ca75a2026-02-16Warnings, Adverse reactionsExact identifier
application number: M020
Sparms 100% Organic Face SunscreenZINC OXIDE SUNSCREENVEGANIC SKN LIMITED4ae6b187-142b-e4a6-e063-6294a90af3652026-02-15WarningsExact identifier
application number: M020
Lotus Harmony - Quinn Shield Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED4ae73d23-1118-716c-e063-6394a90a68c72026-02-15WarningsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC4ab542aa-bd05-ba7a-e063-6294a90ae5842026-02-13Warnings, Adverse reactionsExact identifier
application number: M020
Beauty HydratingHOMOSALATE, ZINC OXIDETopco Associates LLC6e88ccc8-8576-4573-8a5b-28e64008a3492026-02-13Warnings, Adverse reactionsExact identifier
application number: M020
Wotnot Naturals Natural Zinc Sunscreen SPF 30ZINC OXIDEECOdirect Pty Ltd (Trading as Wotnot Naturals)4ab759ae-0c1c-bddc-e063-6394a90a1d092026-02-13WarningsExact identifier
application number: M020
Wotnot Naturals Natural Zinc Sunscreen SPF 30ZINC OXIDEECOdirect Pty Ltd (Trading as Wotnot Naturals)4ab83b34-9376-d169-e063-6394a90a18cd2026-02-13WarningsExact identifier
application number: M020
Homosalate, Octisalate, Zinc oxideHOMOSALATE, OCTISALATE, ZINC OXIDETopco Associates LLC48fb9a3c-c058-ce71-e063-6294a90aaf1e2026-02-13Warnings, Adverse reactionsExact identifier
application number: M020
Ambi Even and Clear Facial MoisturizerHOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 3%, AVOBENZONE 3%73453-112469440e9-bf47-bebd-e063-6294a90acca22026-02-12WarningsExact identifier
application number: M020
Intelligent Defense Mineral SunscreenZINC OXIDEGLO PHARMA4ab664aa-5f0c-7ddb-e063-6294a90a97532026-02-12WarningsExact identifier
application number: M020
Sky and Sol Sports SunscreenZINC OXIDEDelta Ecommerce LLC4dd054cd-8f53-4210-e063-6394a90ade272026-02-12WarningsExact identifier
application number: M020
Sky and Sol Kids and Babies SunscreenZINC OXIDEDelta Ecommerce LLC4de67653-ab31-c6b2-e063-6394a90a7e8c2026-02-12WarningsExact identifier
application number: M020
Eva Claire Natural Professional SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEEva Claire Cosmetics Co., Ltd.4a870452-cac2-4d2c-e063-6294a90abb072026-02-11WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52257-1420-15225714200160 mL in 1 CARTON (52257-1420-1) 60 ml2021-06-010000-00-00NoNoCurrent