Atomy Sunscreen White Broad Spectrum SPF 50 PLUS

Product NDC
52257-1450
Requested package NDC
52257-1450-1
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 134 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-Aging Sun Protection NTTITANIUM DIOXIDE, ZINC OXIDEDERMOPERFECTION SKINCARE SERVICES, LLC351a20df-bd8a-8ea6-e063-6294a90abaaf2025-12-11Exact identifier
application number: M020
Tinted Primer Anti-AgingTITANIUM DIOXIDE, ZINC OXIDEDERMOPERFECTION SKINCARE SERVICES, LLC351aaaad-44ce-3558-e063-6294a90a2b462025-12-11Exact identifier
application number: M020
Total Body Block SunscreenZINC OXIDEADR SUNCARE38f4928c-6389-5aa1-e063-6294a90a8f9d2025-12-11Exact identifier
application number: M020
Magic VeilZINC OXIDETHE COMPLEXIONIST38f574ad-c4bf-fca1-e063-6394a90a00c52025-12-11Exact identifier
application number: M020
Magic VeilZINC OXIDETHE COMPLEXIONIST38f5a0b9-bbe2-50f4-e063-6294a90a10d72025-12-11Exact identifier
application number: M020
Daily Tinted Antioxidant Mineral SunscreenZINC OXIDEMONIKA G KIRIPOLSKY MD INC.3b3f19c1-4bff-315f-e063-6394a90a9a852025-12-11WarningsExact identifier
application number: M020
Daily Repair Moisturizing TintedZINC OXIDESkintique37dd83db-aa43-7f66-e063-6294a90a893b2025-12-11Exact identifier
application number: M020
Daily Repair Moisturizing Non TintedZINC OXIDESkintique37de01d0-7694-69c1-e063-6394a90acf0a2025-12-11Exact identifier
application number: M020
Daily Shield Facial PrimerTITANIUM DIOXIDE, ZINC OXIDESkintique37dd5228-5fe4-5e7b-e063-6294a90adffb2025-12-11Exact identifier
application number: M020
Daily Repair Moisturizing Non TintedZINC OXIDESkintique37ddc177-376d-b2fe-e063-6294a90a5e072025-12-11Exact identifier
application number: M020
Daily Shield Facial PrimerTITANIUM DIOXIDE, ZINC OXIDESkintique37de2f44-e0da-0d1c-e063-6294a90ae18b2025-12-11Exact identifier
application number: M020
Daily Repair Moisturizing TintedZINC OXIDESkintique37de5a51-0bc4-34ad-e063-6294a90a0eef2025-12-11Exact identifier
application number: M020
Mineral SunscreenZINC OXIDELEILANI VIDAL36d51157-1bcd-79c8-e063-6394a90aba712025-12-11Exact identifier
application number: M020
Mineral SunscreenZINC OXIDELEILANI VIDAL36d4b998-c29c-ff89-e063-6394a90a12d82025-12-11Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELEILANI VIDAL36d5831a-7128-729a-e063-6394a90a80362025-12-11Exact identifier
application number: M020
Mineral Matte Non-Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEORAIOS BEAUTY LLC3ac219bd-dfc8-fe22-e063-6394a90a4a8c2025-12-11WarningsExact identifier
application number: M020
Tinted Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEORAIOS BEAUTY LLC3ac25d06-d885-48a2-e063-6294a90a0d0b2025-12-11WarningsExact identifier
application number: M020
Tinted Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEORAIOS BEAUTY LLC3ac27b6c-1341-1f05-e063-6394a90a98602025-12-11WarningsExact identifier
application number: M020
Facial Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEDR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST37287e4c-6fdf-62c5-e063-6394a90a12962025-12-11Exact identifier
application number: M020
Facial Mineral Sunscreen Non TintedTITANIUM DIOXIDE, ZINC OXIDEDR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST37284de3-32d4-3611-e063-6394a90a63932025-12-11Exact 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