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 252 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RV Illuminance Serum Tint Broad Spectrum 15 Buff BeigeFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b3b8b-d38b-cd4d-e063-6294a90a919a2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 HazelFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b3b8b-d38c-cd4d-e063-6294a90a919a2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Cool BeigeFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b48b8-5953-9ab7-e063-6394a90a6b242024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Creamy NaturalFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b311f-9dcd-9b26-e063-6394a90a29a82024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Rich MahoganyFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b6b99-883b-ffd4-e063-6294a90a7f4b2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Light TanFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b557a-ff60-f33f-e063-6394a90ac66f2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Light BeigeFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b6b99-8839-ffd4-e063-6294a90a7f4b2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Light NaturalFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b668d-036e-893e-e063-6294a90a82af2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Rich SandFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b6ba3-b5da-f2f7-e063-6394a90a86ae2024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Soft NutmegFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b856a-d714-892c-e063-6294a90a4ae92024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 SandalwoodFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b856a-d712-892c-e063-6294a90a4ae92024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Tan SandFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b5cca-4e4f-efb6-e063-6294a90a62062024-12-24WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Warm CaramelFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0b9147-3c7a-d549-e063-6394a90a68692024-12-24WarningsExact identifier
application number: M020
Nu Skin 180 Degree UV Defense Hydrator SPF 18OCTINOXATE AND ZINC OXIDENSE Products, Inc91a22a5a-87fd-4db0-9183-caebee4013042024-12-24WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 27 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Incaefd7884-6bc3-4b0b-ba36-1f3e8fe49f932024-12-23WarningsExact identifier
application number: M020
Attitude mineral sunscreen tropical SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude56e57ca0-d163-4580-9bca-747acce4d69f2024-12-23WarningsExact identifier
application number: M020
(S)UNDERCOVER SPF 50ZINC OXIDETUBBY TODDdca478a0-c319-68d8-e053-2a95a90a10fc2024-12-23WarningsExact identifier
application number: M020
LOreal Paris Revitalift Triple Power Anti Aging Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Ince7bef1da-ea35-4306-b043-73d566a7e6bb2024-12-23WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios UV Tone Broad Spectrum SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc46aa9917-52ac-4c57-afde-366d2d3ca2002024-12-23WarningsExact identifier
application number: M020
La Roche Posay Anthelios UV Clear Daily Invisible Broad Spectrum SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc1d115945-fa1b-485b-bf53-44308fd1a6302024-12-23WarningsExact 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