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 323 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DERMAKA Broad Spectrum SPF-42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEDERMAKA SKIN PRODUCTS32b892fd-c68f-4670-bbaa-0b3de57128492023-11-11WarningsExact identifier
application number: M020
WILMA SCHUMANN Moisture Protektiv Day Cream SPF-20OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDESKINMETICS INC4a719986-d1d0-4156-b803-04004b7215042023-11-11WarningsExact identifier
application number: M020
DERMAKA Broad Spectrum SPF-42 Sunscreen UntintedTITANIUM DIOXIDE, ZINC OXIDEDERMAKA SKIN PRODUCTS9aa24e1f-e338-4947-a437-554fb6b227a22023-11-11WarningsExact identifier
application number: M020
TIGER BABY Baby Sunscreen SPF-50ZINC OXIDEBRICKELL BRANDS LLCf2aa0e03-e8b6-42d0-8fa0-2e96ca486b5c2023-11-11WarningsExact identifier
application number: M020
Brickell Mens Products Daily Defense Face Moisturizer SPF-20OCTISALATE, ZINC OXIDEBRICKELL BRANDS LLCa61e20e4-d5c9-4dc4-a18a-cc88b358d15c2023-11-11WarningsExact identifier
application number: M020
EIGHT SAINTS Chase The Sun SPF-30OCTOCRYLENE, OCTISALATE, ZINC OXIDEBRICKELL BRANDS LLC9b19b2b4-d8b9-415d-a217-4a5ef3d75a8c2023-11-11WarningsExact identifier
application number: M020
LUCKY 13s ALL NATURAL TATTOO SUNSCREEN SPF-30ZINC OXIDESALES BRAIN HOLDINGS LLCec06bc4b-90d6-4b41-9086-f57737a34d912023-11-11WarningsExact identifier
application number: M020
TRENDY JOHN SPF-32 Sheer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETRENDY JOHN LLC80dccecb-fbb3-4af6-9cb4-6acea733e9962023-11-11WarningsExact identifier
application number: M020
CARIBBEAN SOL Natural Sunscreen SPF-30ZINC OXIDECaribbean Sol International, LLC19117321-c37b-4b37-9bd6-7c5c973e2f312023-11-11WarningsExact identifier
application number: M020
MIAMI BEACH BUM Blocked SPF-30 SunscreenZINC OXIDEMIAMI BEACH BUM669443a1-7b54-454f-b22f-8cfa9df38bbb2023-11-11WarningsExact identifier
application number: M020
STRYX Daily Moisturizer SPF-30OCTISALATE, ENSULIZOLESTRYX MEN, INC.2bac4348-5b5d-41cc-893e-b9d5c1215ab02023-11-11WarningsExact identifier
application number: M020
SIMPLI DAY All In One SmartCream SPF 42ZINC OXIDE, OCTISALATE, OCTOCRYLENE, ENSULIZOLESIMPLI SKIN MD LLCe5aab0ec-eda2-4073-998a-966202dc22332023-11-11WarningsExact identifier
application number: M020
HAWAIIAN SOL Natural Sunscreen SPF-30ZINC OXIDECaribbean Sol International, LLC3c43fe36-2c24-4859-a262-8af4d3420e472023-11-11WarningsExact identifier
application number: M020
JOYSPRING Kids Mineral Sunscreen SPF-30ZINC OXIDEJOYSPRING HOLDINGS LLC3ca50033-5bcb-4a6d-8aba-a797c5b8d0e92023-11-11WarningsExact identifier
application number: M020
TANCEUTICALS SPF DROPS Broad Spectrum SPF-30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETANCEUTICALS, LLC8640b971-7c99-4c8f-ac5c-ecdd88b99fe02023-11-11WarningsExact identifier
application number: M020
PROTEKT SPF-50 Sheer Mineral SunscreenZINC OXIDEProtekt Products, Inc.806b4e40-0e02-424b-80e7-026a211b4dfe2023-11-11WarningsExact identifier
application number: M020
KOVR All-Natural SPF-30 Moisturizing Sunscreen for WomenTITANIUM DIOXIDE, ZINC OXIDEACTIVE LIFE INC0ddc3bb9-595e-4ebd-ad3e-df4d94fd34ed2023-11-11WarningsExact identifier
application number: M020
Personalized Day Moisturizer with SPF 50ZINC OXIDEProven Skincarebb921e91-9faf-4210-9091-ab511af9012a2023-11-10WarningsExact identifier
application number: M020
Personalized Day Moisturizer with SPFZINC OXIDEProven Skincaref4d682bc-825f-494c-8528-3d328dc639942023-11-10WarningsExact identifier
application number: M020
Ultra Replenishing Sunscreen SPF 40HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXYIDE CREAMCosMedical Technologies, LLC92ad5d7a-9adb-7d55-e053-2995a90a80e72023-11-10WarningsExact 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