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 278 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
First Aid Only SunX30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Acme United Corporation	24c22903-8911-81d9-e063-6394a90a108b	2024-10-18	Warnings	Exact identifier application number: M020
TiZO Eye Renewal SPF 20 (Non-Tinted)	ZINC OXIDE	Fallien Cosmeceuticals, LTD	33f8760c-2953-44a6-9239-424fdb97a5b3	2024-10-18	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c85e5094-d442-55a9-e053-2995a90aed12	2024-10-18	Warnings	Exact identifier application number: M020
Bondi Sands SPF 60 Sunny Face	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BONDI SANDS (USA) INC.	24c78897-3136-f24b-e063-6394a90aa80a	2024-10-18	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Baby and Kids Mineral SPF 50 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fruit Of The Earth, Inc.	f42a0b1e-038d-4fab-e053-2995a90a5364	2024-10-18	Warnings	Exact identifier application number: M020
Cabana Beach Club with Manuka Honey and Essential Oils SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	f451c472-1d9f-1fbc-e053-2995a90a114e	2024-10-18	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Mineral SPF 30 Sunscreen	ZINC OXIDE	Fruit Of The Earth, Inc.	f4490608-6cce-90f3-e053-2995a90a4930	2024-10-18	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Mineral SPF 70 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit Of The Earth, Inc.	f540b0f6-3e6c-43a7-e053-2a95a90aba74	2024-10-18	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Mineral SPF 30 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fruit Of The Earth, Inc.	f4481bf3-6dc7-5641-e053-2a95a90ad938	2024-10-18	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City	LIP BALM SPF 30 SUNSCREEN STICK	Fruit of the Earth, Inc.	3ec16996-ae86-4f5b-b1fd-c7b509cc5d50	2024-10-18	Warnings	Exact identifier application number: M020
Cabana Beach Club with Mentha and Essential Oils SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	f452df0c-ea8d-e25c-e053-2995a90a1143	2024-10-18	Warnings	Exact identifier application number: M020
FRUIT OF THE EARTH 100 DRY TOUCH BROAD SPECTRUM SPF 100 FACE SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	FRUIT OF THE EARTH, INC.	fa18f1a9-7a6a-856e-e053-6294a90aeafa	2024-10-18	Warnings	Exact identifier application number: M020
Cabana Beach Club with Blood Orange and Essential Oils SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	f452f94a-d2f1-60ec-e053-2995a90a8827	2024-10-18	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Mineral SPF 50 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fruit Of The Earth, Inc.	f45d25d2-9305-5858-e053-2a95a90a7f7b	2024-10-18	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Mineral SPF 70 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit Of The Earth, Inc.	f53fff7a-ef8b-19c4-e053-2a95a90a4a2a	2024-10-18	Warnings	Exact identifier application number: M020
Fruit of the Earth LUV THAT SUN Sport Sunscreen Continuous SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Fruit Of The Earth, Inc.	fd68012d-814b-ac07-e053-6394a90afc68	2024-10-18	Warnings	Exact identifier application number: M020
Fruit of the Earth LUV THAT SUN Sport Sunscreen Ultra SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	FRUIT OF THE EARTH, INC.	fd687b34-e4c6-0458-e053-6394a90ac064	2024-10-18	Warnings	Exact identifier application number: M020
Fruit of the Earth LUV THAT SUN Kids Sunscreen Ultra SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	FRUIT OF THE EARTH, INC.	fd786a06-88b7-fa35-e053-6394a90a84a5	2024-10-18	Warnings	Exact identifier application number: M020
Chemical Sunscreen SPF50 with Antipollution	HOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE SUNSCREEN	Swiss-American CDMO, LLC	59efb7dd-83f9-4222-9b7e-ea17ac4ece00	2024-10-18	Warnings	Exact identifier application number: M020
CVS Health SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS Pharmacy	f0d6ac48-3d57-0f5c-e053-2a95a90a87cf	2024-10-17	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