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 298 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Intensive Age Defying Hydrating Complex SPF 25	HOMOSALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE	June Jacobs Labs, LLC	18f59d9d-1328-d815-e063-6294a90a3801	2024-05-21	Warnings	Exact identifier application number: M020
Advanced Sun Resistance SPF 30	HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE	June Jacobs Labs, LLC	18f879f0-3d5b-0067-e063-6394a90a9db3	2024-05-21	Warnings	Exact identifier application number: M020
Protective Tinted Moisturizer Broad Spectrum Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	June Jacobs Labs LLC	18e1edd9-e39b-c91f-e063-6394a90a32a0	2024-05-20	Warnings	Exact identifier application number: M020
Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	June Jacobs Labs, LLC	18e4c50d-eb91-c269-e063-6394a90a7999	2024-05-20	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 30 Tropical Sunscreen	BROAD SPECTRUM SPF 30 TROPICAL SUNSCREEN	Raining Rose, Inc	18e7fc6b-b40a-f790-e063-6294a90ad0f4	2024-05-20	Warnings	Exact identifier application number: M020
Protectif Untinted	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	18aa2604-c8f0-ca04-e063-6294a90a1c25	2024-05-17	Warnings	Exact identifier application number: M020
Vacation Shimmer Oil	AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE	Vacation Inc	150cbb23-fcb9-ed6f-e063-6394a90a597c	2024-05-16	Warnings	Exact identifier application number: M020
Babo Botanicals Daily Sheer Fluid Tinted Mineral Sunscreen SPF 50	ZINC OXIDE	Babo Botanicals, Inc.	d66dfcec-ad40-3a0b-e053-2995a90aa006	2024-05-14	Warnings	Exact identifier application number: M020
Babo Botanicals Daily Sheer Fluid Mineral Sunscreen SPF 50	ZINC OXIDE	Babo Botanicals, Inc.	d66c88a1-7684-1043-e053-2a95a90aa2aa	2024-05-14	Warnings	Exact identifier application number: M020
Jack Black	TITANIUM DIOXIDE, ZINC OXIDE	Jack Black L.L.C	181d5bf3-ce91-cb2c-e063-6294a90a51c4	2024-05-10	Warnings	Exact identifier application number: M020
Protectif Fair Tint	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	181e3f34-c5b2-0976-e063-6394a90a9a78	2024-05-10	Warnings	Exact identifier application number: M020
SABIYA Broad Spectrum SPF-30	ZINC OXIDE	SABIYA, LLC	bc403672-7576-49a6-9a29-4f6cb19af7a4	2024-05-09	Warnings	Exact identifier application number: M020
SABIYA Broad Spectrum SPF-50	ZINC OXIDE	SABIYA, LLC	4264f23f-4f2a-4fd1-ad35-e7d649ee3f5c	2024-05-09	Warnings	Exact identifier application number: M020
Protectif Deep Tint	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	180b2939-5ae4-88fb-e063-6394a90aad93	2024-05-09	Warnings	Exact identifier application number: M020
UV Daily Deep Tint	OCTINOXATE, ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc.	c12fa9a4-d7e5-46bf-9bfb-1cbbaa73b450	2024-05-09	Warnings	Exact identifier application number: M020
Chemical Sunscreen SPF50	OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE SUNSCREEN	Swiss-American CDMO, LLC	50f47495-93aa-4e11-a153-d4c847a36c99	2024-05-08	Warnings	Exact identifier application number: M020
UV Clear Deep Tint	OCTINOXATE, ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc.	ead07d51-9400-4f0a-8966-7052dfae67bc	2024-05-08	Warnings	Exact identifier application number: M020
Essence Pout Protector SPF 20 Lip Balm	HOMOSALATE, OCTISALATE, ZINC OXIDE	cosnova GmbH	17e483c5-6e47-9a50-e063-6394a90aa604	2024-05-07	Warnings, Adverse reactions	Exact identifier application number: M020
MIRABELLA Broad Spectrum SPF 30 Sunscreen	HOMOSALATE, OCTISALATE, AVOBENZONE	GDM ENTERPRISES LLC	3ac847d5-a75d-4b32-84e1-70e4282c0d72	2024-05-06	Warnings	Exact identifier application number: M020
MELAN SPF-30 Broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE	MELAN INC.	75fcef12-bc33-44a7-acda-77d5d7bca2bc	2024-05-02	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