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 275 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IPKN Moist and Firm Beauty Balm Light Medium	TITANIUM DIOXIDE	Inel Cosmetics Co., Ltd.	1af6184e-3dc4-4eb3-8d51-aca724473451	2024-10-25	Warnings	Exact identifier application number: M020
IPKN Moist and Firm Beauty Balm Light	TITANIUM DIOXIDE	Inel Cosmetics Co., Ltd.	77d77838-aa13-4939-a1a0-50189fbb3fe0	2024-10-25	Warnings	Exact identifier application number: M020
Dove Men plus Care Hydrate Face	AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE	CONOPCO Inc. d/b/a Unilever	afe75aff-c056-eaf7-e053-2a95a90af71b	2024-10-24	Warnings	Exact identifier application number: M020
Cancer Council Mineral Fluid SPF50	ZINC OXIDE	Vitality US Co.	1638f8a4-a2da-4e1f-e063-6294a90a03d9	2024-10-24	Warnings	Exact identifier application number: M020
Marlowe SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Marlowe Holdings, LLC	f94bd91a-f0ab-680c-e053-6394a90ac855	2024-10-23	Warnings	Exact identifier application number: M020
Vacation Broad Spectrum SPF 30	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	Vacation Inc.	2526eadf-4b55-ff81-e063-6394a90a3ba7	2024-10-23	Warnings	Exact identifier application number: M020
Tenacious Ergodyne	KREWD CLEAR SPF 50 CONTINUOUS SPRAY	Tenacious Holdings, Inc.	55d99d0a-dc7f-4915-b7c1-f999c8b36e0d	2024-10-23	Warnings	Exact identifier application number: M020
Tenacious Ergodyne	SPF 50 SUNSCREEN LOTION	Tenacious Holdings, Inc.	aaaa1f54-1136-4062-85ba-0926351580bb	2024-10-23	Warnings	Exact identifier application number: M020
Bull Frog SPF 50 Quik with Water Armor Tech	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BULLFROG BRANDS, LLC.	f706f90c-eb79-2201-e053-6394a90a2ce4	2024-10-23	Warnings	Exact identifier application number: M020
Bull Frog SPF 50 Quik with Water Armor Tech	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BULLFROG BRANDS, LLC.	f70816a3-cc04-b000-e053-6294a90a0fae	2024-10-23	Warnings	Exact identifier application number: M020
Alumier MD Post Procedure Kit	TITANIUM DIOXIDE, ZINC OXIDE	Alumier Labs	252859de-6676-5e07-e063-6394a90a64a1	2024-10-23	Warnings	Exact identifier application number: M020
Equate Sunscreen Tanning Oil With Coconut Oil SPF 6	AVOBENZONE, HOMOSALATE	WAL-MART STORES INC.	f44d83d3-ffca-7a93-e053-2a95a90a7715	2024-10-23	Warnings	Exact identifier application number: M020
Tanning Sunscreen UVB Protection Dry Oil Equate	AVOBENZONE, HOMOSALATE, OCTISALATE	WAL-MART STORES INC.	acdf62f2-742e-5df9-e053-2a95a90a96c5	2024-10-23	Warnings	Exact identifier application number: M020
WALMART EQUATE BEAUTY ULTRA LIGHT SUNSCREEN SPF 100	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	WAL-MART STORES INC.	c8d4feca-7bee-2413-e053-2a95a90a739c	2024-10-23	Warnings	Exact identifier application number: M020
Equate Sunscreen for All Skin Tones SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Wal-Mart Stores Inc	f410ffcc-ef0e-13c4-e053-2a95a90a568a	2024-10-23	Warnings	Exact identifier application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 44N	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Rare Beauty, LLC	cffbb6af-5a04-f58a-e053-2995a90a1ae2	2024-10-23	Warnings	Exact identifier application number: M020
Banana Boat	TITANIUM DIOXIDE, ZINC OXIDE	Edgewell Personal Care Brands, LLC	441a46f0-ecda-4448-e054-00144ff88e88	2024-10-23	Warnings	Exact identifier application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 28C	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Rare Beauty, LLC	cffb8219-7076-de64-e053-2a95a90a6036	2024-10-23	Warnings	Exact identifier application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10N	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Rare Beauty, LLC	cfee02eb-92f9-be12-e053-2a95a90a4337	2024-10-23	Warnings	Exact identifier application number: M020
CVS Pharmacy Kids SPF 70 Clear	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	CVS Pharmacy	4eb824a6-66ac-01f8-e054-00144ff8d46c	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