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 95 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Coppertone Kids Sport Sunscreen SPF 100	AVOBENZONE 3%, HOMOSALATE 15%, OCTINOXATE 2% OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%	Beiersdorf Inc	c068a6e7-260f-0766-e053-2995a90a422f	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Suncreen SPF 50	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc	cc43f433-51ff-ed6a-e053-2a95a90ad3c5	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Mineral Sunscreen SPF 50	ZINC OXIDE	Beiersdorf Inc	b5bb6eb6-3356-e2a5-e053-2995a90aa684	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Limited Edition Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc	ccbf7795-e153-1a43-e053-2a95a90ad4b6	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Advanced Hydration SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	cd9cbdb4-42f1-3063-e053-2a95a90a08aa	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Baby Sensitive Mineral SPF 50 Sunscreen	ZINC OXIDE	Beiersdorf Inc	cdb19c82-9845-eabc-e053-2a95a90a31f7	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Advance Hydration Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	cd61e4d7-776d-8d84-e053-2995a90a4819	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Oil-Control SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	cda04484-ba84-2276-e053-2a95a90a41c8	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Kids Sunscreen SPF 60	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	240dd76a-8f39-caec-e063-6294a90abbbc	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Protect and Tan SPF 30	AVOBENZONE 3%, HOMOSALATE 14%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	d3994886-2ebe-a9d2-e053-2995a90aaf9a	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	d3d471b8-7430-98b0-e053-2995a90aba4b	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 60	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	241f78be-0d7f-c5ca-e063-6294a90a997a	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Protect and Tan Sunscreen SPF 45	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdort Inc	d39a009d-1f33-88bb-e053-2a95a90a03a0	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 30	AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%	Beiersdorf Inc	d460d669-42df-46c0-e053-2a95a90ad77b	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Tanning Sunscreen SPF 8	AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%	Beiersdorf Inc	d370094c-3373-594b-e053-2a95a90a114a	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Tanning Sunscreen SPF 15	(TO DELIVER) AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%	Beiersdorf Inc	0a5a35be-9e24-18dd-e063-6394a90a097f	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc	d462081f-f082-5df2-e053-2995a90aa1d9	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	d3e66496-bc3c-d189-e053-2a95a90a06b6	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Kids Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc.	c05388dc-4282-ee79-e053-2a95a90a376a	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Glow Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	b60dcbd1-42d0-646f-e053-2a95a90a497d	2025-12-31	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