Atomy Sunscreen White Broad Spectrum SPF 50 PLUS

Product NDC: 52257-1410
11-digit product format: 522571410
Labeler code: 52257
Product ID: 52257-1410_53421adc-c420-4009-e063-6394a90a7360
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52257-1410-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52257-1410-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52257-1410-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52257-1410-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52257-1410-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52257-1410-1	`1332a3947898…`	`d4bfe170f9cd…`

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
Ingredient	Strength
HOMOSALATE	4.5 g/60mL
OCTISALATE	2.7 g/60mL
TITANIUM DIOXIDE	1.32 g/60mL
ZINC OXIDE	7.62 g/60mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V06SV4M95S	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
15FIX9V2JP	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
ad0b9091-a990-45bf-93f4-d886be1bbffe	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-12-03	ad0b9091-a990-45bf-93f4-d886be1bbffe
2024-12-03	ad0b9091-a990-45bf-93f4-d886be1bbffe
2024-01-30	ad0b9091-a990-45bf-93f4-d886be1bbffe
2024-01-30	ad0b9091-a990-45bf-93f4-d886be1bbffe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52257-1410-1	Atomy Sunscreen White Broad Spectrum SPF 50 PLUS	60 mL in 1 CARTON	CREAM	60		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52257-1410	ATOMY SUNSCREEN WHITE BROAD SPECTRUM SPF 50 PLUS (HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ATOMY CO., LTD.]	3	Current NDC, Legacy NDC, 1 package rows	20241205_ad0b9091-a990-45bf-93f4-d886be1bbffe.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 179 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kinesys Broad Spectrum SPF 50 Alcohol Free Sunscreen	OCTOCRYLENE, OCTINOXATE, HOMOSALATE, OCTISALATE, AND AVOBENZONE	Wilc Healthcare Inc	998fe524-6469-4c9b-889b-3191882149ce	2025-10-13	Warnings	Exact identifier application number: M020
Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE , ZINC OXIDE	Skinlycious Pte Ltd	e0ad02c3-f5ed-4b72-ba96-07d9c489a4ea	2025-10-13	Warnings	Exact identifier application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Buff	ZINC OXIDE	Cosmetic Enterprises Ltd	265bc5e0-0a2a-842e-e063-6394a90aae0a	2025-10-13	Warnings	Exact identifier application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Mocha	ZINC OXIDE	Cosmetic Enterprises Ltd	2748b6bc-e80b-ce66-e063-6394a90a400a	2025-10-13	Warnings	Exact identifier application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Bronze	ZINC OXIDE	Cosmetic Enterprises Ltd	265bf123-c4c3-8414-e063-6394a90a4730	2025-10-13	Warnings	Exact identifier application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Ivory	ZINC OXIDE	Cosmetic Enterprises Ltd	2748c351-0a7d-6913-e063-6394a90a6ef2	2025-10-13	Warnings	Exact identifier application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Nude	ZINC OXIDE	Cosmetic Enterprises Ltd	265bd73f-2509-90c6-e063-6294a90a2e19	2025-10-13	Warnings	Exact identifier application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	dad4b244-2d34-40cb-88dc-991358df83b0	2025-10-10	Warnings	Exact identifier application number: M020
Neutrogena Beach Defense Kids Sunscreen SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	eafc00ce-12e7-921f-e053-2995a90a241a	2025-10-10	Warnings	Exact identifier application number: M020
Kinesys	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Wilc Healthcare Inc	50adf1db-118f-4843-b356-e23993160673	2025-10-10	Warnings	Exact identifier application number: M020
Kinesys Broad Spectrum SPF 30 Alcohol-Free Performance Sunscreen - Fragrance Free	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Wilc Healthcare Inc	e0949325-7de1-4da4-82b6-8004916412a0	2025-10-10	Warnings	Exact identifier application number: M020
Meijer SPF 50 Sunscreen Mango	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Meijer	40d0294b-e937-336d-e063-6294a90a5c3c	2025-10-10	Warnings	Exact identifier application number: M020
Kinesys Broad Spectrum SPF 30 Kids Alcohol-Free Sunscreen	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Wilc Healthcare Inc	9adea1a4-efa6-4fe1-85e8-ed69fa098a87	2025-10-10	Warnings	Exact identifier application number: M020
Kinesys Broad Spectrum SPF 30 Alcohol-Free Sunscreen - Mango Scent	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Wilc Healthcare Inc	60e7ed8e-f421-4e08-97a8-af647200e4ae	2025-10-10	Warnings	Exact identifier application number: M020
KINeSYS Pro Sport Lip Balm with Shea Butter Broad Spectrum 30	ZINC OXIDE	Wilc Healthcare Inc	e5820376-897f-4c77-aadc-7991137870b7	2025-10-10	Warnings	Exact identifier application number: M020
KINeSYS Pro Sport Clear Mineral Sunscreen Stick Broad Spectrum SPF45	ZINC OXIDE	Wilc Healthcare Inc	247a323f-9a08-4717-8553-ebc9c519817b	2025-10-10	Warnings	Exact identifier application number: M020
Vertra S Dorian Kona Gold Signature Face Stick SPF 38	TITANIUM DIOXIDE	Eai-jr 286, Inc	b6c316c3-661b-6428-e053-2a95a90a1a6b	2025-10-10	Warnings	Exact identifier application number: M020
Meijer SPF 50 Sunscreen Coconut	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Meijer	40d15366-85b8-f5e8-e063-6294a90a5fd8	2025-10-10	Warnings	Exact identifier application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Wasatch Product Development, LLC	f4369f2f-fdc3-e48e-e053-2995a90a07f7	2025-10-10	Warnings	Exact identifier application number: M020
Sun Bum Face 50 Premium Sunscreen SPF 50	AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE	Wasatch Product Development, LLC	f4ac746a-a50a-8041-e053-2a95a90a8ea6	2025-10-10	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52257-1410-1	52257141001	60 mL in 1 CARTON (52257-1410-1)	60 ml	2021-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
WATER - ATOMY CO., LTD. \| Kolmar Korea Co., Ltd	ATOMY CO., LTD. \| Kolmar Korea Co., Ltd	2026-06-02	HUMAN OTC DRUG LABEL	4