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 258 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mineral Lip Balm SPF-15	ZINC OXIDE	TUBBY TODD	4d938672-5302-4e47-a582-c3e6467008cb	2024-12-18	Warnings	Exact identifier application number: M020
SaltyFace Daily Sun Shield Mineral Sunscreen For Face SPF 30	ZINC OXIDE	Saltyface Natural Inc	f0cc7ce9-81b3-439f-b5ee-96138de54e78	2024-12-18	Warnings	Exact identifier application number: M020
Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50 Jasmine	TITANIUM DIOXIDE, ZINC OXIDE	EK Clothing LLC dba Belasol	e999d752-6c00-459e-b6c3-d264c330597d	2024-12-18	Warnings	Exact identifier application number: M020
Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	EK Clothing LLC dba Belasol	f22626c1-0996-41d8-a2ec-3bf7491df657	2024-12-18	Warnings	Exact identifier application number: M020
Costa Sea Mineral Sunscreen SPF 50	ZINC OXIDE	COSTA SEA INC	841e1b3d-dbbc-4bb0-886a-fb2d077ae739	2024-12-18	Warnings	Exact identifier application number: M020
SPF 50 plus Sunscreen All Mineral Active Ingredients	TITANIUM DIOXIDE AND ZINC OXIDE	KAS Direct LLC dba BabyGanics	247aae3d-1845-4dd8-b774-b9e8214809a2	2024-12-18	Warnings	Exact identifier application number: M020
Softlips Vanilla, Watermelon, Cherry	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	2235d029-157e-4a30-be90-605e6bc143fd	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Salted Caramel, Candy Apple, Marshmallow Ghost	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	42cf4623-0eb8-455a-b374-8e17e9336b92	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Peppermint Mocha, Apple Chai Cider, Orange Cranberry	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	0338c078-695d-4d4e-9e90-5a8a98d49524	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Pearl Plus Vanilla	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	107bcaa9-4347-4979-be44-35183a9ee67e	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Raspberry	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	d18b4c19-0365-44ec-bea8-4328e537e0d8	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Watermelon	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	03062f13-270d-49cf-8939-2349f12e9cba	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Vanilla Watermelon	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	f733747a-ad1a-4222-baf1-69dcd90a3350	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Vanilla Watermelon	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	1fbe85a2-4cd7-45bd-85a2-83bbf75c5f97	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Marshmallow Ghost	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	8d55141d-5d6f-4eec-87dc-d3c808cf7a6a	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Pearl	OCTINOXATE, OCTISALATE	The Mentholatum Company	43e175b4-7a48-431e-bf27-9ce7dee53f5e	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Oasis Watermelon Blackberry	DIMETHICONE, OXYBENZONE, OCTINOXATE	The Mentholatum Company	e1213808-4dad-4fd0-871a-04bba094a3cc	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Peppermint	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	1a0062f1-fcfc-4d6a-8274-2ebbc5fbdb27	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Oasis Pineapple Coconut, Peach Mango, Strawberry Kiwi	DIMETHICONE, OXYBENZONE, OCTINOXATE	The Mentholatum Company	7c8a4921-ae45-47fb-a64e-c72b1a386d0d	2024-12-17	Warnings	Exact identifier application number: M020
Mentholatum Medicated Lip Balm Cherry	DIMETHICONE, OCTINOXATE, OCTISALATE	The Mentholatum Company	6edb132d-bb67-4e6c-8e18-db0305073a71	2024-12-17	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