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 67 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Touch in SOL No Poreblem Airbrushed PrimerOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEBONNE Co., Ltd4685ff24-0bb0-3502-e063-6394a90abfee2026-01-29WarningsExact identifier
application number: M020
Sheer Touch Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEAldi, Incc7650d20-7cb9-4861-8a30-cf4a9cd424e92026-01-29Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEAldi, Inc32c0613e-0f5a-47f5-b2f3-f32ae07cbc762026-01-29Warnings, Adverse reactionsExact identifier
application number: M020
Vacation Original Coconut SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.a9a0b558-b8e6-44ea-9b57-6938837a04fb2026-01-29WarningsExact identifier
application number: M020
SHISEIDO SPORTS BB DARKOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONf4fc4b6a-9507-496e-9ecb-8400055ecf2d2026-01-28WarningsExact identifier
application number: M020
Hampton Sun SPF 30 MineralZINC OXIDE 7.20% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCb8ee428e-07d3-4c6c-853c-cfbe3e4002d92026-01-28WarningsExact identifier
application number: M020
SHISEIDO FUTURE LX UNIVERSAL DEFENSE SOCTISALATE, OCTOCRYLENE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATION0a6f8eef-48e9-44f5-9811-629bc0dc07d02026-01-28WarningsExact identifier
application number: M020
Hampton Sun SPF 45 Tinted FaceHOMOSALATE 10% OCTOCRYLENE 6% AVOBENZONE 3%S&C Hampton Sun LLC0fc0f2c7-ec0f-4976-9872-82a6bfe8b46b2026-01-28WarningsExact identifier
application number: M020
Walgreens 70 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY49775d1a-e573-a596-e063-6294a90a7cf62026-01-28WarningsExact identifier
application number: M020
AVON ANEW ULTIMATE MULTI-PERFORMANCE DAY BROAD SPECTRUM SPF 25 SUNSCREENAVOBENZONE, HOMOSALATE, OCTINOXATE, OXYBENZONEThe Avon Company49784430-2ffe-0cbb-e063-6394a90adb232026-01-28WarningsExact identifier
application number: M020
ALOE UP SPORT SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC3f2f90f1-28dd-48e8-9083-ea04815acc6b2026-01-28WarningsExact identifier
application number: M020
ALOE UP PRO 30 CONTINUOUS SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEAloe Care International, LLCbaf32d84-4db5-4ed0-9814-5470b7d1f4a42026-01-28WarningsExact identifier
application number: M020
ALOE UP PRO 15AVOBENZONE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC5b0f43fc-f4a6-4403-a40e-e0198a6f2ebd2026-01-28WarningsExact identifier
application number: M020
ALOE UP PRO 50 CONTINUOUS SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEAloe Care International, LLCdc33d9e8-3463-485d-a1ee-6319ed91454c2026-01-28WarningsExact identifier
application number: M020
ALOE ICE SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEAloe Care International, LLCe4b861d2-3680-4ed7-8650-d1d839da5ab22026-01-28WarningsExact identifier
application number: M020
ALOE UP SPORT SPF-15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC1bf1635a-825e-417f-97b4-4bce6d251d192026-01-28WarningsExact identifier
application number: M020
Mineral SunscreenZINC OXIDE 20%The Daily Suncare LLC, DBA Daily Shade1a392f6b-1bb1-c49d-e063-6294a90a791d2026-01-28WarningsExact identifier
application number: M020
KIZO LAB UV DEFENSE CLEAR SUNSCREN SPF50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEYB CHEMIA LLC0053ae49-b9a1-c3f4-e063-6394a90abcb82026-01-28WarningsExact identifier
application number: M020
Orange GelAVOBENZONE OCTISALATE OCTOCRYLENE HOMOSALATEVacation Inc.132896ef-d6c6-4ec7-e063-6294a90a103b2026-01-28WarningsExact identifier
application number: M020
REDEFINE Triple DefenseAVOBENZONE, OCTISALATE, OCTOCRYLENERodan & Fieldsd1dd62c6-33ac-4941-ab99-9eb8cc3c208a2026-01-27WarningsExact 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