FDA.reportPublic FDA data

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 230 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetaphil Sheer Mineral Sunscreen Stick SPF 50TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.54f6df65-e90c-4070-aa95-f47496dd11bd2025-01-27WarningsExact identifier
application number: M020
Cetaphil Healthy Renew Day Cream Broad Spectrum SPF 30HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEGalderma Laboratories, L.P.5b4e25ad-cd72-4960-9259-fc710bfd59da2025-01-27WarningsExact identifier
application number: M020
Well People Daygleamer Liquid Mineral Sunscreen SPF 34ZINC OXIDEe.l.f. Cosmetics, Inc.2c7621e9-0f1d-4712-e063-6294a90abd642025-01-24WarningsExact identifier
application number: M020
Equate Sunscreen SPF 30 SPORT Broad SpectrumAVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENEWal-Mart Stores Inc1697628a-91d2-45bc-bd1b-91fb38f3f8df2025-01-24WarningsExact identifier
application number: M020
DR.JART EVERY SUN DAY SUN FLUIDHOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEHave & Be Co., Ltd.f06d8f90-f3df-6d76-e053-2a95a90af1f82025-01-24WarningsExact identifier
application number: M020
CoTZ Silky Foam - TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDd63088d7-a1d7-4b56-a7d8-ad217011a8a82025-01-24WarningsExact identifier
application number: M020
CoTZ Silky Foam Non-TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD9c04b76e-ae65-4183-b475-3b8e8764db592025-01-24WarningsExact identifier
application number: M020
natural lip balm SPF15(unflavored) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.2c5a460a-dc93-14cc-e063-6294a90a0b612025-01-23WarningsExact identifier
application number: M020
360 by QUR Lemon Verbena lip balmOCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEQur, Incbedb14c2-9181-5970-e053-2a95a90a41612025-01-23WarningsExact identifier
application number: M020
Soleo Organics SunscreenZINC OXIDESE Operations Pty Ltd59ea43e3-f6e6-4d10-9d8f-2f14eaf2f79b2025-01-22WarningsExact identifier
application number: M020
Neptune Ave. High Dive Barrier Repair Moisturizer Broad Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENENeptune Ave. Inc.25034563-6420-daf6-e063-6394a90af9802025-01-22WarningsExact identifier
application number: M020
Jafra Sun body protector sunscreen broad spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.b8e49dd6-305c-f717-e053-2995a90a659c2025-01-22WarningsExact identifier
application number: M020
Jafra Royal Defy Sample KitAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.c3b265b1-ab84-4ea9-b283-c92f5a4cf4612025-01-22WarningsExact identifier
application number: M020
SUNSCREEN BROAD SPECTRUM SPF 50 FACE AND BODYAVOBENZONE/OCTISALATE/OCTOCRYLENEMary Kay Inc.2c4eaf2e-b034-8185-e063-6394a90a82752025-01-22WarningsExact identifier
application number: M020
Herbalife SKIN Protective Moisturizer Broad Spectrum SPF 30 Mineral SunscreenZINC OXIDEHerbalife International of America Inc.d30b7cf1-73bb-3568-e053-2995a90ad5792025-01-21WarningsExact identifier
application number: M020
Herbalife Herbal Aloe Face and Body Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEHerbalife International of America, Inc.d30d9d02-bc31-db3c-e053-2a95a90a0dab2025-01-21WarningsExact identifier
application number: M020
Sugargirl Disco Stick SPF 30HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC36f30834-62be-4076-9493-f385720a1e222025-01-20WarningsExact identifier
application number: M020
Sugargirl Glowy Face Screen Shimmer Sunscreen SPF 30HOMOSALATE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, AVOBENZONEI World LLC757897b0-fc65-4147-8444-2a0efdc6f81c2025-01-20WarningsExact identifier
application number: M020
Sugargirl Hot Body Screen Shimmer Sunscreen SPF 30HOMOSALATE, OCTOCRYLENE, OCTINOXATE, AVOBENZONE, OCTISALATEI World LLCa9bf1342-1c4b-48ad-a955-715647df125a2025-01-20WarningsExact identifier
application number: M020
JAFRA SKIN Glow Face Cream Broad Spectrum SPF 15 SunscreenHOMOSALATE, OCTISALATE, AVOBENZONE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.Vf627ab5b-85d4-4c92-9412-4bab72828f3d2025-01-17WarningsExact 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