FDA.reportPublic FDA data

ATOMY BB SUNSCREEN

Product NDC
52257-1430
11-digit product format
522571430
Labeler code
52257
Product ID
52257-1430_53421317-2f22-b017-e063-6294a90a41f2
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
ATOMY CO., LTD.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-01
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
8.22; 5.76 g/100mL; g/100mL
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 BB SUNSCREEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE8.22 g/100mL
ZINC OXIDE5.76 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
b0cd27ee-4917-4800-bcdf-c6e14b28c1d1Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52257-1430-12024-01-31C16284748780-11030e364-fa55-111a-e063-dadaa90a10e2b0cd27ee-4917-4800-bcdf-c6e14b28c1d1
52257-1430-12024-01-31C16284748780-11030e364-fa55-111a-e063-dadaa90a10e2b0cd27ee-4917-4800-bcdf-c6e14b28c1d1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52257-1430-1ATOMY BB SUNSCREEN40 mL in 1 CARTONCREAM403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52257-1430ATOMY BB SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ATOMY CO., LTD.]3Current NDC, 1 package rows20240201_b0cd27ee-4917-4800-bcdf-c6e14b28c1d1.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 313 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coola Bare Republic Mineral Body Gel-Lotion SPF 30ZINC OXIDE 18.2%COOLA LLCd745d12e-8741-4bf2-89ec-c6f72a8d548b2023-12-20WarningsExact identifier
application number: M020
COOLA Classic Body Sunscreen SPF 70 - Peach BlossomAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC6efa0d9f-0ff3-4b2f-9587-9630261bcbd12023-12-20WarningsExact identifier
application number: M020
sugar rush skin treat poreless tinted moisturizer Broad Spectrum SPF 20 Sunscreen lightTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.b49d5dc5-8d9b-49e4-8d07-d0d6af3fbbdc2023-12-20WarningsExact identifier
application number: M020
Coola Bare Republic Mineral Face Gel-Lotion SPF 30ZINC OXIDE 18.2%COOLA LLCad1614d4-5421-473d-a1e8-0ff18491df772023-12-20WarningsExact identifier
application number: M020
COOLA CLASSIC FACE SUNSCREEN White Tea Broad Spectrum SPF 50AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEBentley Laboratories, LLC4e0e426d-f037-428f-98f2-2d3e945bd0402023-12-19WarningsExact identifier
application number: M020
COOLA Classic Body Sunscreen Fragrance-Free SPF 50AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEBentley Laboratories, LLC57f2fdeb-2abc-4ad3-bb89-5faee883c0e52023-12-19WarningsExact identifier
application number: M020
Baby Bare Republic Mineral Sunscreen SoftStick SPF 50ZINC OXIDECOOLA LLC1a603f62-86ec-4e66-a73f-718c5d0126762023-12-19WarningsExact identifier
application number: M020
COOLA Classic Body Sunscreen Pina Colada SPF 30AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEBentley Laboratories, LLCd508cef6-977f-4231-8c19-491569e999212023-12-19WarningsExact identifier
application number: M020
Nudestix Daily Mineral Veil SPF 30 Tint - HotZINC OXIDE 15%Bentley Laboratories, LLCa9e7a203-52f0-4a67-b3ea-65ff0968ec182023-12-19WarningsExact identifier
application number: M020
COOLA Refreshing Water Mist SPF 18AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBentley Laboratories, LLC658bf3fe-2246-40b6-8cb1-969bfdaffd1b2023-12-19WarningsExact identifier
application number: M020
Nudestix Daily Mineral Veil SPF 30 Tint Free - CoolZINC OXIDE 15%Bentley Laboratories, LLCcd80661f-348c-4bfd-a85c-041db1a1d0f42023-12-19WarningsExact identifier
application number: M020
Nudestix Daily Mineral Veil SPF 30 Tint - WarmZINC OXIDE 15%Bentley Laboratories, LLCd5fd3fea-5dcf-42ef-927a-3b4a3e1ccff82023-12-19WarningsExact identifier
application number: M020
foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 13N fair neutralTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.f5d54e9d-4963-419a-a091-bdbd1decd2b82023-12-19WarningsExact identifier
application number: M020
CHEVOURI Brightening Serum Broad Spectrum SPF-40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECHE'VOURI LLC5a93d5f9-9313-4194-8c39-c513f5a858532023-12-18WarningsExact identifier
application number: M020
Valentino Very Valentino Light Lasting Perfecting Foundation Broad Spectrum SPF 26 SunscreenOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE9598949a-0dd6-4932-9dc8-354f9e10b6012023-12-18WarningsExact identifier
application number: M020
BB blur tinted moisturizer Broad Spectrum SPF 30 lightTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.207aaa0c-777f-4abd-96b7-64666eb87f532023-12-18WarningsExact identifier
application number: M020
Valentino Very Valentino Light Lasting Perfecting Foundation Broad Spectrum SPF 26 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc69e0d803-be76-4cc3-bdeb-b50401d5d6d42023-12-18WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 DeepTITANIUM DIOXIDE AND ZINC OXIDECosmetique Active Production8bdd63f7-2f67-4280-9484-d6c8e80ad9b92023-12-16WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium DeepTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc8ab49def-c9cd-489e-a936-467067a889402023-12-16WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium DeepTITANIUM DIOXIDE AND ZINC OXIDECosmetique Active Production0cb8f22d-2343-415e-9f16-1791567864a12023-12-16WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52257-1430-15225714300140 mL in 1 CARTON (52257-1430-1) 40 ml2023-10-01NoNoCurrent