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 283 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TopCare Everyday Ultimate Sheer Sun Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	TOPCO ASSOCIATES LLC	c51029f4-ede0-08ef-e053-2995a90aecaf	2024-10-15	Warnings	Exact identifier application number: M020
TOPCARE EVERYDAY SPORT CONTINUOUS BROAD SPECTRUM SPF 30	AVOBENZONE, HOMOSALATE, OCTOCRYLENE,	TOPCO ASSOCIATES LLC	c8af028e-9d68-4023-e053-2995a90ad18a	2024-10-15	Warnings	Exact identifier application number: M020
TOPCARE EVERYDAY ULTRA PROTECTION SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TOPCO ASSOCIATES LLC	c5601d22-2353-7319-e053-2a95a90a16c0	2024-10-15	Warnings	Exact identifier application number: M020
TOPCARE EVERYDAY CONTINUOUS BROAD SPECTRUM SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TOPCO ASSOCIATES LLC	c8c12a5a-59f5-6515-e053-2995a90a58f7	2024-10-15	Warnings	Exact identifier application number: M020
Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TOPCO ASSOCIATES LLC	c6268778-8dcc-24b6-e053-2995a90acf03	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Sport Sun SPF 50	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	TOPCO ASSOCIATES LLC	f0de2999-f12b-89b1-e053-2a95a90ac610	2024-10-15	Warnings	Exact identifier application number: M020
TOPCO TOPCARE EVERYDAY MINERAL SUNSCREEN ZINC OXIDE SPF 50	ZINC OXIDE	TOPCO ASSOCIATES LLC	d501a94e-3bcd-d8e4-e053-2a95a90a33b0	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Kids Mineral Sunscreen	ZINC OXIDE	TOPCO ASSOCIATES LLC	dbee42c8-9cae-7a81-e053-2a95a90a2329	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Sport Sun Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TOPCO ASSOCIATES LLC	f12c09b1-8ffe-4933-e053-2995a90a434f	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Mineral Sunscreen Zinc Oxide SPF 30	ZINC OXIDE	TOPCO ASSOCIATES LLC	dbf03882-ab1a-9805-e053-2995a90a7109	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Mineral Sunscreen Continuous Broad Spectrum SPF 50 Reef-Conscious Formula	TITANIUM DIOXIDE, ZINC OXIDE	TOPCO ASSOCIATES LLC	f14f43e6-ee57-5495-e053-2a95a90a4011	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Sport Continuous Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	TOPCO ASSOCIATES LLC	f31ea60e-1f52-c55f-e053-2a95a90afe64	2024-10-15	Warnings	Exact identifier application number: M020
Topco Topcare Everyday Mineral Sunscreen Continuous SPF 30	ZINC OXIDE	TOPCO ASSOCIATES LLC	f71e019b-392a-f8eb-e053-6394a90a871e	2024-10-15	Warnings	Exact identifier application number: M020
TOPCARE EVERYDAY SPORT SPF 70 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	TOPCO ASSOCIATES LLC	a5b06600-f2b0-6d9b-e053-2995a90a59f0	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Ultra Protection Sun SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TOPCO ASSOCIATES LLC	f41d4c46-7998-afe6-e053-2995a90ab361	2024-10-15	Warnings	Exact identifier application number: M020
TOPCO TOPCARE EVERYDAY BABY PROTECTION SUN SPF 50	OCTISALATE, ZINC OXIDE	TOPCO ASSOCIATES LLC	f71c9060-3daf-e1be-e053-6294a90a4f91	2024-10-15	Warnings	Exact identifier application number: M020
MINERAL SUNSCREEN SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	TOPCO ASSOCIATES LLC	bfe076fa-f21f-2c46-e053-2a95a90acee4	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Mineral Sunscreen Stick	ZINC OXIDE	H.E.B.	f58f0199-bf22-2197-e053-2995a90ae64f	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Kids Blue Mineral Sunscreen Stick Berry Scented	ZINC OXIDE	H.E.B.	f58d328c-8b30-b4d4-e053-2a95a90adb59	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Kids Purple Mineral Sunscreen Stick Grape Scented	ZINC OXIDE	H.E.B.	f58ed2f9-67c3-ce91-e053-2995a90a1229	2024-10-15	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