FDA.reportPublic FDA data

Atomy Sunscreen White Broad Spectrum SPF 50 PLUS

Product NDC
52257-1450
11-digit product format
522571450
Labeler code
52257
Product ID
52257-1450_ef3ff0c4-289d-4a0d-9c99-32c7a106bec5
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
2026-12-31
Current FDA listing
Yes

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
2026-12-31

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
b8bc0021-bb4d-45f2-a570-3f2e61edf21dAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52257-1450-1Atomy Sunscreen White Broad Spectrum SPF 50 PLUS60 mL in 1 CARTONCREAM601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52257-1450ATOMY SUNSCREEN WHITE BROAD SPECTRUM SPF 50 PLUS (HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ATOMY CO., LTD.]1Current NDC, 1 package rows20240217_b8bc0021-bb4d-45f2-a570-3f2e61edf21d.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 80 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NELLY DEVUYST BIOSOLAR COLORLIFT 3 TINTED SUNSCREEN SPF30ZINC OXIDELABORATOIRES DRUIDE INC19af4441-31b2-72db-e063-6394a90a813c2026-01-14WarningsExact identifier
application number: M020
Sqween Paint-On Sun Protection for Independent Kids Mineral Sunscreen SPF 30ZINC OXIDESqween LLC9c3cf35b-4bde-46e3-8abd-5f4d1ad6e4862026-01-14WarningsExact identifier
application number: M020
SCENTUAL AROMA BEAUTY SUN VEIL SPF30TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES DRUIDE INC0799ac38-9a41-6579-e063-6394a90ac4b62026-01-14WarningsExact identifier
application number: M020
NUDA CANADA SOLARGLOW MINERAL SERUM SUNSCREEN SPF30ZINC OXIDELABORATOIRES DRUIDE INC0b412e24-baf6-e68e-e063-6394a90a5f492026-01-14WarningsExact identifier
application number: M020
Dr. C. Tuna Sun Stick SPF 50AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETIfc89d1b5-1ffe-4f06-8c5c-31f2eb0b56412026-01-14WarningsExact identifier
application number: M020
Oiana Mineral Sunscreen DropsZINC OXIDEOiana LLC4860257d-a8bf-7ce5-e063-6394a90a74db2026-01-14WarningsExact identifier
application number: M020
Standard Procedure Lip Balm SPF 50ZINC OXIDE HOMOSALATE OCTOCRYLENEStandard Procedure Inc1e3db995-b1c5-3a2e-e063-6294a90af75e2026-01-14WarningsExact identifier
application number: M020
Standard Procedure SPF 50 SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEStandard Procedure Inc1d3f87de-90c0-75c0-e063-6394a90a2ef42026-01-14WarningsExact identifier
application number: M020
EELHOE Bio Sun StickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.48654406-505b-518b-e063-6394a90a5add2026-01-14WarningsExact identifier
application number: M020
JAYSUING Hyaluronic Acid Moisturizing SunscreenTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.48662fae-2d41-4a4a-e063-6394a90a15222026-01-14WarningsExact identifier
application number: M020
CALIFORNIA ALOE FRESH POW DERY SUNHOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANENATURE REPUBLIC CO., LTD.aa10dbbf-97b3-4258-bbd3-0d8cc9935e122026-01-13WarningsExact identifier
application number: M020
COSRXVITAMIN E VITALIZING SUNSCREENCOSRX inc.4840f608-944a-3e3d-e063-6394a90a1d9d2026-01-13WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Face Serum Sunscreen Broad Spectrum SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCb043f0f3-b263-4c49-86ca-9ecc71a22aa82026-01-13WarningsExact identifier
application number: M020
ARAMORE MULTI-DEFENSE SUNSCREEN - AM Broad Spectrum SPF 30ZINC OXIDENew Frontier Bio, Incef6c8443-fd10-2022-e053-2a95a90a45ea2026-01-13WarningsExact identifier
application number: M020
Bluevado SunfixZINC OXIDE, TITANIUM DIOXIDEMagic Blue, LLC2e5315bf-39f4-401c-8207-18ef6a97e0242026-01-13WarningsExact identifier
application number: M020
Intellishade TruPhysical SPF 45TITANIUM DIOXIDE, ZINC OXIDERevision, LLCe20f5dc9-e863-b090-e053-2a95a90a50442026-01-13WarningsExact identifier
application number: M020
Intellishade TruPhysical Clear SPF 50TITANIUM DIOXIDE, ZINC OXIDERevision, LLC1305fa94-47d5-7a42-e063-6394a90a0aba2026-01-13WarningsExact identifier
application number: M020
Intellishade Clear SPF 50AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATERevision, LLCe213b46d-d061-dc83-e053-2995a90ad8752026-01-13WarningsExact identifier
application number: M020
Intellishade Matte SPF 45OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDERevision, LLCe213ae87-4db2-3070-e053-2995a90a083b2026-01-13WarningsExact identifier
application number: M020
Sun Project MoistureHOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE, BUTYL METHOXYDIBENZOYLMETHANETHANK YOU FARMER CO., LTD20a83f02-d851-4aac-e063-6394a90ae1a62026-01-13WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52257-1450-15225714500160 mL in 1 CARTON (52257-1450-1) 60 ml2021-06-01NoNoCurrent