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 206 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc48980ef3-ebda-450e-9f15-effad27dec9a2025-07-11WarningsExact identifier
application number: M020
KLARINA Sheer Mineral Sunscreen Blender SPF 50ZINC OXIDEKLARINA INC081941e3-02da-43a2-bf6f-a6d0f053272f2025-07-10WarningsExact identifier
application number: M020
ATHLETIC COSMETIC COMPANY Clear Power Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEATHLETIC COSMETIC COMPANY LLCf143a8e0-b32b-4b14-a6ae-f013627b484c2025-07-10WarningsExact identifier
application number: M020
Venofye Orchard Bee Brilliance SPF 30OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONEInnovation Brands Inc.7c36c7e5-bc0b-40e6-bdbc-fd34f0b0eafe2025-07-10WarningsExact identifier
application number: M020
Touch Anti-Aging SPF 30 MoisturizerZINC OXIDE, OCTINOXATE, AND OCTISALATEDiractions Capital LLC47ce948e-5848-43a1-880e-aeb78e9ad1b32025-07-10WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc06f2ced8-273e-454f-92b4-2846f6674b372025-07-10WarningsExact identifier
application number: M020
SPF30 unseen sunscreen 01BUTYL METHOXYDIBENZOYLMETH, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENECosmuses Cosmetics (Ningbo) Co., Ltd.398bb1f5-80ea-c589-e063-6294a90abefd2025-07-09WarningsExact identifier
application number: M020
Prada Reveal Skin Optimizing Foundation Broad Spectrum SPF 17 SunscreenENSULIZOLESICOS ET CIE1ac50772-0bea-4a41-8300-03f65f0bed522025-07-09WarningsExact identifier
application number: M020
Prada Reveal Skin Optimizing Foundation Broad Spectrum SPF 17 SunscreenENSULIZOLEL'Oreal USA Products Ince74a8c43-ec70-4de1-b2b5-0e89e40bfb402025-07-08WarningsExact identifier
application number: M020
IT COSMETICS HELLO SUNSHINE INVISIBLE HYDRATING SERUM BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inc.84fbbb01-bb16-41a6-a53a-6e85d515ca2c2025-07-08WarningsExact identifier
application number: M020
CeraVe Developed with Dermatologists Hydrating Sheer Sunscreen Broad Spectrum SPF 30 Face and Body Water Resistant 80 Minutes Hybrid FormulaHOMOSALATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDEL'Oreal USA Products, Inc.cd69df67-5231-4a75-a9fb-a8669806a8922025-07-08WarningsExact identifier
application number: M020
Neutrogena Beach Defense Kids Sunscreen SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLCfea50c84-0567-8547-e053-6394a90aafb72025-07-07WarningsExact identifier
application number: M020
24K Skin Tone Moisturizer SPF 30OCTINOXATE, HOMOSALATE, OCTISILATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.b4f37f69-c61d-40c6-86cc-95d041b4d1b52025-07-07WarningsExact identifier
application number: M020
Vine Vera Resveratrol Cabernet Replenishing MoistureOCTINOXATE, HOMOSALATE, OCTISILATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.c48a7346-3971-4946-b527-a5549a98e2462025-07-07WarningsExact identifier
application number: M020
Lavelier Divine Day Defense Broad Spectrum SPF 30OCTINOXATE, HOMOSALATE, OCTISILATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.1f33a93f-ae3f-4024-9d23-26b01eed17642025-07-03WarningsExact identifier
application number: M020
HIGHHEAT Sunscreen SPF 50 Performance For AthletesAVOBENZONE, OCTISALATE, OCTOCRYLENEDUGOUT ESSENTIALS LLC3b7cddb5-00d2-4998-8eec-5e5a7c5a60972025-07-03WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.39093b2d-3fbb-8378-e063-6294a90ac6d82025-07-03Exact identifier
application number: M020
Neutrogena Clear Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC09ccb37b-78ee-b510-e063-6294a90a48d52025-07-01WarningsExact identifier
application number: M020
First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEPort Jervis Laboratories, Inc.4b442fdf-a9cf-7e5a-e063-6394a90a9e1e2025-07-01WarningsExact identifier
application number: M020
Sincerely Yours Sunny Side Up Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDESincerely Yours Inc.4c9dfa22-70f7-83f6-e063-6394a90aa8c52025-07-01WarningsExact 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