Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUS

Product NDC: 52257-1420
11-digit product format: 522571420
Labeler code: 52257
Product ID: 52257-1420_53422040-2fac-e1fd-e063-6294a90a328b
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	52257-1420-1	`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	52257-1420-1	`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	52257-1420-1	`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	52257-1420-1	`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	52257-1420-1	`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	52257-1420-1	`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 Beige 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
994d5680-284e-4faf-a29b-4d28f8d46e8f	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	994d5680-284e-4faf-a29b-4d28f8d46e8f
2024-12-03	994d5680-284e-4faf-a29b-4d28f8d46e8f
2024-01-30	994d5680-284e-4faf-a29b-4d28f8d46e8f
2024-01-30	994d5680-284e-4faf-a29b-4d28f8d46e8f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52257-1420-1	Atomy Sunscreen Beige 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
52257-1420	ATOMY SUNSCREEN BEIGE BROAD SPECTRUM SPF 50 PLUS (HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ATOMY CO., LTD.]	3	Current NDC, Legacy NDC, 1 package rows	20241205_994d5680-284e-4faf-a29b-4d28f8d46e8f.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 276 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Health 60 Plus Sensitive Skin Sun	TITANIUM DIOXIDE, ZINC OXIDE	CVS Pharmacy	477c25ec-33db-04a6-e054-00144ff8d46c	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health SPF 70 Clear	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	CVS Pharmacy	4eb75945-9d65-55b4-e054-00144ff88e88	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health Sport SPF 50 Clear	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,	CVS Pharmacy	4ec6384a-8faf-5712-e054-00144ff8d46c	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health Sport SPF 30 Clear	AVOBENZONE, HOMOSALATE, OCTOCRYLENE,	CVS Pharmacy	4ec6b50b-5236-6f5b-e054-00144ff8d46c	2024-10-22	Warnings	Exact identifier application number: M020
CVS Pharmacy SPF 70 Beach Guard Clear	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	CVS Pharmacy	4ec75d23-a33b-6c52-e054-00144ff88e88	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health SPF 70 Beach Guard Sun	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	CVS Pharmacy	4adbd66a-6b38-046d-e054-00144ff8d46c	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health Sport SPF 100 Clear	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	CVS Pharmacy	651c245c-2d3a-0019-e053-2991aa0a4637	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health SPF 70 Sun	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	CVS Pharmacy	63b420ba-ac69-5670-e053-2a91aa0a864b	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health Ultra Sheer SPF 100 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	CVS PHARMACY	c52a7e9b-5401-f6e7-e053-2995a90a9519	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health Ultra Sheer Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	CVS Pharmacy	c68c3d6a-b656-abaf-e053-2a95a90a48db	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health Ultra Sheer Broad Spectrum SPF 45 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS Pharmacy	c5e8fcc9-db5c-9ee7-e053-2a95a90ac940	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health SPF 55 Ultra Sheer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS Pharmacy	c617cdec-b489-22d2-e053-2995a90a1ec6	2024-10-22	Warnings	Exact identifier application number: M020
TRADER JOES ILLUMINATING DAILY FACIAL SUNSCREEN BROAD SPECTRUM SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Trader Joe's Company	1b7c2f13-81b8-7af5-e063-6294a90a3501	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health SPF 50 Beach Guard	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS Pharmacy	df25c35d-6b6d-1ef8-e053-2995a90aaef5	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health Kids SPF 50 Clear	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS PHARMACY	e4581d0e-ce6d-7898-e053-2a95a90a02b5	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health SPF 55 Ultra Sheer Face Mist	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS Pharmacy	dfb55b46-e88f-4949-e053-2995a90adabc	2024-10-22	Warnings	Exact identifier application number: M020
CVS Health Sport SPF 30 Clear Broad Spectrum	AVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENE	CVS PHARMACY	e4589114-87c5-56b8-e053-2995a90a0934	2024-10-22	Warnings	Exact identifier application number: M020
TRADER JOES ENRICH MOISTURIZING FACE BROAD SPECTRUM SPF 15	OCTINOXATE, ZINC OXIDE	Trader Joe's Company	a6805675-916c-4a19-b993-d465fcef58a1	2024-10-22	Warnings	Exact identifier application number: M020
TRADER JOES FACE AND BODY SUNSCREEN SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Trader Joe's Company	057ac99c-60e8-47c1-a32d-984bbd181846	2024-10-22	Warnings	Exact identifier application number: M020
TRADER JOES ZINC OXIDE MINERAL SUNSCREEN SPF 30	ZINC OXIDE	Trader Joe's Company	9e48de83-cb72-4c03-a819-939db8793e1f	2024-10-22	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
52257-1420-1	52257142001	60 mL in 1 CARTON (52257-1420-1)	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