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
2027-12-31
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
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
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 260 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 40OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEBobbi Brown Professional Cosmetics Inc.dc6b28ca-b922-460a-8028-fb3f5afdbe9d2024-12-16WarningsExact identifier
application number: M020
BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 30OCTINOXATE, TITANIUM DIOXIDE AND ZINC OXIDEBobbi Brown Professional Cosmetics Inc.1f9a4b71-45aa-4156-9fe6-ffa81f808a852024-12-16WarningsExact identifier
application number: M020
AHAVA Protecting Moisturizing SPF50AVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEAHAVA - Dead Sea Laboratories Ltd7502e06d-754b-4cb8-ba4c-91eee04539322024-12-16WarningsExact identifier
application number: M020
Natural Finish Pressed Foundation SPF 20 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEColoresciencec389e183-bfad-4813-af09-fae3aa05e82a2024-12-16WarningsExact identifier
application number: M020
Sunforgettable Total Protection Brush-On Shield SPF 50TITANIUM DIOXIDE AND ZINC OXIDEColoresciencec77357f1-7ada-4325-86f7-5ee801610f422024-12-16WarningsExact identifier
application number: M020
Sunforgettable Total Protection Sheet Matte Sunscreen SPF 30ZINC OXIDEColorescience5b6f906e-6620-48b0-9c39-0eb1c8dc1c632024-12-16WarningsExact identifier
application number: M020
Ryshi SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Rite Aide313350f-74d9-370b-e053-2995a90aeeaf2024-12-15WarningsExact identifier
application number: M020
Annmarie SPF 20 SunscreenZINC OXIDE 15%Annmarie Gianni Skin Care LLCcc722ce1-0ded-19d5-e053-2995a90a7d032024-12-15WarningsExact identifier
application number: M020
Zinka SPF 30 Clear SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8%Zinka, Incc054ac39-d03f-17c1-e053-2a95a90aa5ef2024-12-15WarningsExact identifier
application number: M020
QC SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%CDMAf82080b1-ef90-a027-e053-6294a90a19f22024-12-15WarningsExact identifier
application number: M020
QC SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6%CDMAf80ceb05-0bd4-1355-e053-6294a90afb192024-12-15WarningsExact identifier
application number: M020
Lip Shine SPF35 SunscreenZINC OXIDEColorescience3a6506c4-1ba9-493a-a4c8-e5f9c60d221b2024-12-13WarningsExact identifier
application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM DEEPZINC OXIDECOSMAX USA, CORPORATION292165af-545d-db43-e063-6394a90ad1832024-12-13WarningsExact identifier
application number: M020
Tinted Lip Cream SPF 15ZINC OXIDECOSMAX USA, CORPORATION29227121-e579-8eea-e063-6394a90a302f2024-12-13WarningsExact identifier
application number: M020
BOBBI BROWN PRIMER PLUS PROTECTION BROAD SPECTRUM SPF50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,AND OXYBENZONEBobbi Brown Professional Cosmetics Inc.03372376-ef03-943d-e063-6394a90a52ee2024-12-13WarningsExact identifier
application number: M020
WEIGHTLESS SKIN FOUNDATION BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDEBobbi Brown Professional Cosmetics Inc.fbd04b66-738b-2762-e053-6394a90a8b722024-12-13WarningsExact identifier
application number: M020
Mentholatum Natural Ice CherryDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company33f43f14-8e0b-41b1-8ad0-5723d2a7bf192024-12-13WarningsExact identifier
application number: M020
Absolutely Natural Broad Spectrum SPF 8 SunscreenZINC OXIDEAbsolutely Naturala26217cf-22ab-4c39-980a-b73467e16b912024-12-13WarningsExact identifier
application number: M020
Calming Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColorescienced681cdb5-307e-4a2a-8e1d-2b29131d48d02024-12-13WarningsExact identifier
application number: M020
Absolutely Natural Broad Spectrum SPF 15 SunscreenZINC OXIDEAbsolutely Natural8084a3ee-fe31-4cb4-8d3c-e4035d29e5612024-12-13WarningsExact 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