FDA.reportPublic FDA data

Atomy Sunscreen White Broad Spectrum SPF 50 PLUS

Product NDC
52257-1410
11-digit product format
522571410
Labeler code
52257
Product ID
52257-1410_53421adc-c420-4009-e063-6394a90a7360
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 packagepackage52257-1410-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52257-1410-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52257-1410-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52257-1410-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52257-1410-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52257-1410-11332a3947898…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 White 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
ad0b9091-a990-45bf-93f4-d886be1bbffeAvailable 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
2024-12-03ad0b9091-a990-45bf-93f4-d886be1bbffe
2024-12-03ad0b9091-a990-45bf-93f4-d886be1bbffe
2024-01-30ad0b9091-a990-45bf-93f4-d886be1bbffe
2024-01-30ad0b9091-a990-45bf-93f4-d886be1bbffe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52257-1410-1Atomy Sunscreen White Broad Spectrum SPF 50 PLUS60 mL in 1 CARTONCREAM603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52257-1410ATOMY SUNSCREEN WHITE BROAD SPECTRUM SPF 50 PLUS (HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ATOMY CO., LTD.]3Current NDC, Legacy NDC, 1 package rows20241205_ad0b9091-a990-45bf-93f4-d886be1bbffe.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 338 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Strawberry Limoncello SPF 15 Broad Spectrum Lip BalmSTRAWBERRY LIMONCELLO SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incc222bd6e-59b0-394a-e053-2995a90ae4292023-10-18WarningsExact identifier
application number: M020
Raspberry Lime Margarita SPF 15 Broad Spectrum Lip BalmRASPBERRY LIME MARGARITA SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incc2150247-ff7d-9863-e053-2995a90a3f012023-10-18WarningsExact identifier
application number: M020
Key Lime Pie Shake SPF 15 Broad Spectrum Lip BalmKEY LIME PIE SHAKE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incc214e5c2-53ea-31bd-e053-2995a90a886a2023-10-18WarningsExact identifier
application number: M020
Summer Sangria SPF 15 Broad Spectrum Lip BalmSUMMER SANGRIA SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incc222cc2d-232c-0f3d-e053-2995a90af79b2023-10-18WarningsExact identifier
application number: M020
Broad Spectrum SPF 30 Mineral Sun StickBROAD SPECTRUM SPF 30 MINERAL SUN STICKRaining Rosec2261a55-12e4-9a75-e053-2a95a90a82112023-10-18WarningsExact identifier
application number: M020
Broad Spectrum SPF 30 SunscreenBROAD SPECTRUM SPF 30 SUNSCREENRaining Rosec238ce45-91d9-e9fa-e053-2a95a90a7d652023-10-18WarningsExact identifier
application number: M020
Broad Spectrum SPF 30 SunscreenBROAD SPECTRUM SPF 30 SUNSCREENRaining Rosec23d49bd-8447-4920-e053-2a95a90a0a062023-10-18WarningsExact identifier
application number: M020
Tropical Mint Broad Spectrum SPF 15 Lip MoisturizerTROPICAL MINT SPF 15 BROAD SPECTRUM LIP MOISTURIZERRaining Rose, Incaef6b419-efac-4e37-e053-2995a90a0d2f2023-10-18WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Cherry Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN CHERRY LIP BALMRaining Roseefbd2179-5f6d-a8c6-e053-2a95a90a17e72023-10-18WarningsExact identifier
application number: M020
Vanilla Mint Broad Spectrum SPF 15 Lip MoisturizerVANILLA MINT SPF 15 BROAD SPECTRUM LIP MOISTURIZERRaining Rose, Incaf10a007-6597-2231-e053-2995a90a87172023-10-18WarningsExact identifier
application number: M020
Mint Broad Spectrum SPF 15 Lip MoisturizerMINT SPF 15 BROAD SPECTRUM LIP MOISTURIZERRaining Rose, Incaf471721-54e4-0738-e053-2a95a90a7e122023-10-18WarningsExact identifier
application number: M020
Spearmint SPF 15 Broad Spectrum Lip BalmSPEARMINT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca9029e6d-7443-efe2-e053-2995a90a81252023-10-18WarningsExact identifier
application number: M020
Watermelon Twist SPF 15 Broad Spectrum Lip BalmWATERMELON TWIST SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca903a7cc-0de5-5adc-e053-2a95a90aa9612023-10-18WarningsExact identifier
application number: M020
Vanilla Mint SPF 15 Broad Spectrum Lip BalmVANILLA MINT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca9031b15-d2b0-d248-e053-2a95a90a65ff2023-10-18WarningsExact identifier
application number: M020
Cherry SPF 15 Broad Spectrum Lip BalmCHERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca75a7326-aaa4-767b-e053-2995a90adf162023-10-18WarningsExact identifier
application number: M020
Wildberry SPF 15 Broad Spectrum Lip BalmWILDBERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca903c855-867b-4f14-e053-2a95a90a53332023-10-18WarningsExact identifier
application number: M020
Tropical SPF 15 Broad Spectrum Lip BalmTROPICAL SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca903202b-1dc6-85ad-e053-2995a90a4ab82023-10-18WarningsExact identifier
application number: M020
Pomegranate SPF 15 Broad Spectrum Lip BalmPOMEGRANATE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca901e45d-2ea6-bae8-e053-2a95a90afc982023-10-18WarningsExact identifier
application number: M020
Vanilla SPF 15 Broad Spectrum Lip BalmVANILLA SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca903a7cc-0dd5-5adc-e053-2a95a90aa9612023-10-18WarningsExact identifier
application number: M020
Raspberry SPF 15 Broad Spectrum Lip BalmRASPBERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca902917c-b8fb-b2d0-e053-2995a90a42db2023-10-18WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52257-1410-15225714100160 mL in 1 CARTON (52257-1410-1) 60 ml2021-06-010000-00-00NoNoCurrent