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 78 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior27bb6424-9aa6-408a-a9f4-874cb60c8f1f2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorea170049-ec16-4c9d-a73d-368f6b747d572026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb6fb14f0-a3e3-4545-bb4a-f9c27190b11b2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6cb14dcf-8b70-40c3-882b-063d8922ce4c2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diore4dbfd77-0eec-4d1a-94d6-4daca096d8c72026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior72569958-cd7d-4d52-add4-2b13706e1b1e2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior0f5aa600-4168-419b-95d7-569764b5f0b92026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Diore5ab0cd9-ae7f-4558-b5ab-e0b5826772242026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb9fa3bb9-12ec-40d8-b433-a96d9d00cc902026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf7b2e348-2c7f-4ff5-8ab0-a3475c9d1f262026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior69924eb8-a8ca-4ea0-b087-c865a6a1313f2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5cafac21-fb2d-4d63-a7fe-01bf53b941e82026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorbfc27e8d-e59b-46f7-aec9-2a96a00a7c1c2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior8fd56c86-ef37-4f31-87d1-6283a19c84242026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior91b62ba7-2deb-47e6-b9af-25bb459b4d752026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6eec7554-38ed-48d4-916d-ab3660fbf7032026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior939e6d5c-3dd7-4b01-af18-697dc4ba2d992026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior7149784b-3548-4643-abf6-58fde237bb982026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior061181d8-5387-4541-a7d7-426cba5997a02026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf6ad554a-4795-4149-b066-c53a0989470e2026-01-16WarningsExact 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