FDA.reportPublic FDA data

ATOMY SUN

Product NDC
52257-1390
11-digit product format
522571390
Labeler code
52257
Product ID
52257-1390_c14f4060-24d5-4889-be57-c06b4d1e8bf3
Type
HUMAN OTC DRUG
Nonproprietary name
HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE
Dosage form
STICK
Route
TOPICAL
Labeler
ATOMY CO., LTD.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-01
Substance
HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength
2.02; 1.35; .67; .4 g/15g; g/15g; g/15g; g/15g
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 SUN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE2.02 g/15g
OCTOCRYLENE1.35 g/15g
OCTISALATE.67 g/15g
AVOBENZONE.4 g/15g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bdf0a11d-3563-4b09-a430-f031709cb3f3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52257-1390-1ATOMY SUN15 g in 1 CARTONSTICK152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52257-1390ATOMY SUN (HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE) STICK [ATOMY CO., LTD.]2Current NDC, Legacy NDC, 1 package rows20240131_bdf0a11d-3563-4b09-a430-f031709cb3f3.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 297 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RMS SUNCOVERUP SUPER TINT SPF 50 MAHOGANYZINC OXIDERms organics LLC1a1aebea-ed0c-ac92-e063-6294a90aeae62024-06-04WarningsExact identifier
application number: M020
Brush On Block SPF 30 Mineral Powder Translucent Zinc OnlyZINC OXIDESPF Ventures, LLC1a1bf910-f1bc-bd75-e063-6294a90a663f2024-06-04WarningsExact identifier
application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD0b62062d-b77e-4e6c-b3ab-b35ab24db7cb2024-06-04WarningsExact identifier
application number: M020
Protectif Deep TintZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.19b19023-1340-6609-e063-6394a90a6eaf2024-05-30WarningsExact identifier
application number: M020
EltaMD UV Sport SPF50ZINC OXIDE, OCTINOXATE AND OCTISALATE SUNSCREENCP Skin Health Group, Inc.dffc3fde-5b6e-4a62-8289-9733be43455b2024-05-30WarningsExact identifier
application number: M020
Vacation by Vacation Scent and Shimmer DuoAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation Inc.aef8388f-84bb-4e2b-8ae2-aa64f415a6322024-05-28WarningsExact identifier
application number: M020
SPF50 Sunscreen CariposaZINC OXIDETalent Brands Company LLC1938fa13-875a-140e-e063-6294a90a55142024-05-24WarningsExact identifier
application number: M020
Derma E Vitamin C Weightless Moisturizer SPF 45ZINC OXIDEderma ea3b404a6-e4b1-4c08-a8ef-77446dd2e4112024-05-24WarningsExact identifier
application number: M020
COOLA Classic Liplux Lip Balm SPF 30 OriginalAVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA, LLCeeb420f0-c92f-0d96-e053-2a95a90afe362024-05-22WarningsExact identifier
application number: M020
COOLA Mineral Liplux Lip Balm SPF 30 Nude BeachTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCee2842c3-65e0-3904-e053-2a95a90aabff2024-05-22WarningsExact identifier
application number: M020
COOLA Mineral Liplux Lip Balm SPF 30 FirecrackerTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCee026a1c-885b-256f-e053-2a95a90af5642024-05-22WarningsExact identifier
application number: M020
Bare Republic SPF 50 Mineral Sunscreen Vanilla CocoTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCec96dee8-85e8-3147-e053-2995a90aaf532024-05-22WarningsExact identifier
application number: M020
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Bronze GoddessTITANIUM DIOXIDECOOLA, LLCeeb406c6-a543-379a-e053-2995a90a49982024-05-22WarningsExact identifier
application number: M020
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Fresh RoseTITANIUM DIOXIDECOOLA, LLCee01642f-478e-b307-e053-2a95a90a7d812024-05-22WarningsExact identifier
application number: M020
Bare Republic SPF 30 Mineral Sunscreen Coco MangoZINC OXIDECOOLA, LLCeca9ae89-19dc-516d-e053-2995a90a46982024-05-22WarningsExact identifier
application number: M020
Bare Republic Mineral Matte Untinted Face SPF 30TITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCecabcc89-fb09-41a9-e053-2995a90a8b312024-05-22WarningsExact identifier
application number: M020
Bare Republic Mineral Matte Tinted Face SPF 30TITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCee018c21-dca7-28aa-e053-2a95a90a3bdb2024-05-22WarningsExact identifier
application number: M020
Bare Republic SPF 30 Mineral Sunscreen Citrus CoolerZINC OXIDECOOLA, LLCecaad342-1873-60bc-e053-2995a90a59522024-05-22WarningsExact identifier
application number: M020
Bare Republic Mineral Shimmer SPF 30 Golden DazeTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCeeb70034-0f8d-a46d-e053-2a95a90a81302024-05-22WarningsExact identifier
application number: M020
Bare Republic Mineral Shimmer SPF 30 Diamond DustTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCeec83ecb-d0ab-7857-e053-2995a90a40ed2024-05-22WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52257-1390-15225713900115 g in 1 CARTON (52257-1390-1) 15 g2021-05-010000-00-00NoNoCurrent