Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUS

Product NDC
52257-1460
11-digit product format
522571460
Labeler code
52257
Product ID
52257-1460_8e047cb0-2107-4da5-bf4b-389e0a44f60d
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 Beige 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
711aa92c-81b0-42e4-b83f-9ce95116ec03Available 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
52257-1460-1Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUS60 mL in 1 CARTONCREAM601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52257-1460ATOMY SUNSCREEN BEIGE BROAD SPECTRUM SPF 50 PLUS (HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ATOMY CO., LTD.]1Current NDC, 1 package rows20240217_711aa92c-81b0-42e4-b83f-9ce95116ec03.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 346 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antioxidant Sunscreen SPF 40OCTINOXATE AND ZINC OXIDETopiderm, Inc.2686378c-8827-47fb-b3ed-07438bd4e9e22019-11-13WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool VanillaOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASd701c221-9f68-47ff-b766-2f4f1998649f2019-10-08WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 AmberOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS7f5e6872-4d26-410e-8afe-16a016f9a3992019-10-08WarningsExact identifier
application number: M020
No7 Perfect and Perfect Advanced All in One Foundation SPF 50 Warm IvoryOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS1124ba7d-a328-409b-8c88-e74bb3e501f52019-10-08WarningsExact identifier
application number: M020
No7 Perfect and Perfect Advanced All in One Foundation SPF 50 HoneyOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS9c407dc7-fcde-4660-9a06-57bd8a6b867d2019-10-08WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 ChestnutOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASf07e8bb2-30ae-4337-ad60-84f55f2ff3542019-10-08WarningsExact identifier
application number: M020
Thinkbaby Sunscreen SPF 30ZINC OXIDEthinkOperations,LLC86249f33-e635-4455-a039-3a25aa3478df2019-03-25WarningsExact identifier
application number: M020
Sun Defense Mineral Sunscreen SPF 30 FaceZINC OXIDEderma e635ae850-7ce4-4cb7-bdaf-bec00904ca022018-11-12WarningsExact identifier
application number: M020
Thinksport Sunscreen SPF 30ZINC OXIDEthinkOperations,LLCa8591509-65f7-4e62-8642-4b8e63f1fef32018-11-08WarningsExact identifier
application number: M020
Essential Defense Everyday Clear Broad Spectrum SPF 47 SunscreenZINC OXIDE AND OCTINOXATEAllergan, Inc.bc872876-20e7-40cb-b79d-68998883681a2016-03-01WarningsExact identifier
application number: M020
TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen (Tinted)OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.6a996e03-907f-4e6a-b232-0892b86956b02015-08-21WarningsExact identifier
application number: M020
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD.30468afc-9616-4765-b046-12e97a0a78272010-12-20WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52257-1460-15225714600160 mL in 1 CARTON (52257-1460-1) 60 ml2021-06-01NoNoCurrent