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#

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 184 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr Lift Mineral SPF 50TITANIUM DIOXIDE, ZINC OXIDESpa de Soleil40c03d65-8d09-371a-e063-6294a90a7ac62025-10-09WarningsExact identifier
application number: M020
Organys Derma Made SheerZINC OXIDEOrganys Beauty0b39f550-bd34-509d-e063-6294a90a51d02025-10-09WarningsExact identifier
application number: M020
Organys Derma MadeZINC OXIDEOrganys Beauty0b37a73b-73ca-501f-e063-6294a90a62912025-10-09WarningsExact identifier
application number: M020
Organys Derma MadeZINC OXIDEOrganys Beauty09b8b8c0-4066-9cbe-e063-6394a90aca242025-10-09WarningsExact identifier
application number: M020
Dr Lift Mineral SPF 30TITANIUM DIOXIDESpa de Soleil40c0e0d2-2c1d-e629-e063-6394a90a5aaf2025-10-09WarningsExact identifier
application number: M020
Daybird Tinted Skincare (SHADE 3)ZINC OXIDEResette, Incdc89ab76-da32-4f6f-e053-2995a90a8bcb2025-10-09WarningsExact identifier
application number: M020
Daybird Tinted Skincare (SHADE 4)ZINC OXIDEResette, Incdc89ab0b-d53e-983f-e053-2a95a90a127f2025-10-09WarningsExact identifier
application number: M020
Petroleum-Free Lip BalmOCTINOXATE AND OXYBENZONEMedline Industries, LP6125d98a-6fc7-4f50-924e-3b1f7ee951f42025-10-09WarningsExact identifier
application number: M020
Daybird Tinted Skincare (SHADE 1)ZINC OXIDEResette, Incdc89429a-022c-dd10-e053-2a95a90ac26a2025-10-09WarningsExact identifier
application number: M020
Daybird Tinted Skincare (SHADE 2)ZINC OXIDEResette, Incdc89ab76-da2f-4f6f-e053-2995a90a8bcb2025-10-09WarningsExact identifier
application number: M020
Dr Lift SPF 50 Clear StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESpa de Soleil40c11b19-fc91-2033-e063-6394a90a5a5f2025-10-09WarningsExact identifier
application number: M020
Black Girl Sunscreen Make It Mineral BabyZINC OXIDEBlack Girl Sunscreen302bccc6-7bf3-cc69-e063-6294a90a625c2025-10-09WarningsExact identifier
application number: M020
Babo Botanicals Sheer Zinc Mineral Sunscreen SPF30ZINC OXIDEBabo Botanicals, Inc.08f0436b-85b6-5099-e063-6294a90a4c2e2025-10-09WarningsExact identifier
application number: M020
CoreTex Professional Outdoor Skin Protection WalletCORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLETCoreTex Products Incf57bc089-405b-cdcd-e053-2995a90a9d122025-10-09WarningsExact identifier
application number: M020
Mist Me SPF-40ZINC OXIDECove Suncare LLCb7f09089-54a4-4f60-b632-e3f4321313ec2025-10-09WarningsExact identifier
application number: M020
Essential Defense Mineral Shield Broad Spectrum SPF 35 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.29817fdc-f14c-4013-a8ed-4367f3b2867c2025-10-09WarningsExact identifier
application number: M020
Skinny Dip SPF-50ZINC OXIDECove Suncare LLC7bef2966-9351-4ea6-aeed-0d568376d86b2025-10-08WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Broad Spectrum SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC0f0ba2e9-126f-13c0-e063-6394a90aa6a42025-10-08WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC08997bd4-d6b9-fffc-e063-6294a90a77ae2025-10-08WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEKenvue Brands LLC75f81b2d-cabc-443f-b4b5-76bd2321826b2025-10-08WarningsExact 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