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 279 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS HEALTH SPORT SPF 50 CLEAR SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS PHARMACY	f13f7361-56b3-7ea8-e053-2995a90a7641	2024-10-17	Warnings	Exact identifier application number: M020
CVS Health SPF 50 Ultra Protection	AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE	CVS PHARMACY	f11650bb-90a0-78a1-e053-2995a90a8e4c	2024-10-17	Warnings	Exact identifier application number: M020
CVS Health Sport SPF 70 Clear	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	CVS Pharmacy	f31dd448-dc79-21f1-e053-2a95a90a7bb6	2024-10-17	Warnings	Exact identifier application number: M020
CVS Health SPF 30 Breakout Free Face	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS PHARMACY	f41478c8-76c0-727f-e053-2a95a90a8669	2024-10-17	Warnings	Exact identifier application number: M020
CVS Health SPF 30 Ultra Protection	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS PHARMACY	f12ba764-afea-3f81-e053-2a95a90a1291	2024-10-17	Warnings	Exact identifier application number: M020
CVS Health SPF 30 Ultra Sheer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS PHARMACY	f32ec4ef-352e-6a78-e053-2995a90af491	2024-10-17	Warnings	Exact identifier application number: M020
CVS Health Sport SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS PHARMACY	f40e5664-e3ca-badf-e053-2a95a90a913e	2024-10-17	Warnings	Exact identifier application number: M020
CVS Health Sport SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS PHARMACY	f799bad7-b3df-f9a5-e053-6294a90ab104	2024-10-17	Warnings	Exact identifier application number: M020
CVS Health SPF 30 Clear	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS PHARMACY	f41e145c-896e-2782-e053-2995a90a5f81	2024-10-17	Warnings	Exact identifier application number: M020
CVS Health AM Moisturizing Facial Broad Spectrum SPF 30 Sunscreen	HOMOSALATE, OCTOCRYLENE, ZINC OXIDE	CVS PHARMACY	f9c89108-1568-ee3e-e053-6294a90ac756	2024-10-17	Warnings	Exact identifier application number: M020
CVS Health 50 Clear Zinc Broad Spectrum SPF 50 Sunscreen	OCTOCRYLENE, ZINC OXIDE	CVS PHARMACY	fa19e9d3-6ab8-cbd6-e053-6294a90aae9b	2024-10-17	Warnings	Exact identifier application number: M020
CVS Health Sport 30 Clear	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	CVS PHARMACY	fbe6ae15-28ef-2acf-e053-6394a90a8d42	2024-10-17	Warnings	Exact identifier application number: M020
CVS Health 45 Ultra Sheer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS Pharmacy	fc4addf0-9a6e-292f-e053-6294a90ab9c0	2024-10-17	Warnings	Exact identifier application number: M020
CVS Health Sport 70	AVOBENZONE. HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS PHARMACY	fc4a79ce-208e-2aed-e053-6394a90a06bb	2024-10-17	Warnings	Exact identifier application number: M020
CVS Health Sport 70 Clear	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE	CVS PHARMACY	fc4bbb80-c3f6-c4f7-e053-6394a90a4cae	2024-10-17	Warnings	Exact identifier application number: M020
SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	DEMOULAS SUPER MARKETS, INC	ee782436-9eff-49e4-8edc-fd9783454c07	2024-10-17	Warnings	Exact identifier application number: M020
GLOW RECIPE WATERMELON GLOW DEW BALM SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE	Aramara Beauty LLC dba Glow Recipe	0c437f88-c731-5834-e063-6394a90a3299	2024-10-17	Warnings	Exact identifier application number: M020
SPF 30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	DEMOULAS SUPER MARKETS, INC	5ce3e436-37d1-4918-bb14-0be33b0bc86a	2024-10-17	Warnings	Exact identifier application number: M020
MARKET BASKET KIDS SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	DEMOULAS SUPER MARKETS, INC.	a6a381da-6e34-bffe-e053-2a95a90a46f2	2024-10-17	Warnings	Exact identifier application number: M020
Market Basket Continuous Sunscreen SPF 50	AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE	DEMOULAS SUPER MARKETS, INC.	f4238107-c76c-266a-e053-2a95a90a8978	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