Cotz Sensitive SPF 40

Product NDC: 58892-418
11-digit product format: 588920418
Labeler code: 58892
Product ID: 58892-418_42e4a18c-6169-4411-b1b0-918d4cf744e6
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: LOTION
Route: TOPICAL
Labeler: Fallien Cosmeceuticals, LTD.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-03-30
Substance: ZINC OXIDE
Active strength: 200 mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 40 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
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58892-418-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58892-418-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58892-418-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58892-418-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58892-418-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58892-418-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58892-418-01	`0efc9e666f02…`	`f202fb6c5f17…`
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	58892-418-01	`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	58892-418-01	`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	58892-418-01	`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	58892-418-01	`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	58892-418-01	`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	58892-418-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	58892-418-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	58892-418-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	58892-418-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	58892-418-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	58892-418-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	58892-418-01	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	58892-418-01	`110d247fa046…`	`a55b01930146…`

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: Cotz Sensitive SPF 40
Brand name suffix: Sunscreen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
885a674b-3457-4dfe-a801-529094b00499	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58892-418-01	2025-04-02	C162847	48780-1	9855d018-e4b6-cd31-e053-dbdaa90ab51a	885a674b-3457-4dfe-a801-529094b00499
58892-418-01	2019-11-27	C162847	48780-1	9855d018-e4b6-cd31-e053-dbdaa90ab51a	885a674b-3457-4dfe-a801-529094b00499

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58892-418-01	Cotz Sensitive SPF 40 Sunscreen	100 g in 1 TUBE	LOTION	100		2
58892-418-01	Cotz Sensitive SPF 40 Sunscreen	1 in 1 CARTON	LOTION	1		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1
Zinc Oxide	ACTIVE MOIETY	SOI2LOH54Z	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1
.Alpha.-Tocopherol Acetate	INACTIVE INGREDIENT	9E8X80D2L0	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1
Alkyl (C12-15) Benzoate	INACTIVE INGREDIENT	A9EJ3J61HQ	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1
Caprylhydroxamic Acid	INACTIVE INGREDIENT	UPY805K99W	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1
Caprylyl Glycol	INACTIVE INGREDIENT	00YIU5438U	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1
Cetyl PEG/PPG-10/1 Dimethicone (HLB 5)	INACTIVE INGREDIENT	035JKJ76MT	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1
Cyclomethicone 5	INACTIVE INGREDIENT	0THT5PCI0R	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1
Cyclomethicone 6	INACTIVE INGREDIENT	XHK3U310BA	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1
Dimethicone 100	INACTIVE INGREDIENT	RO266O364U	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1
Dimethicone/Diene Dimethicone Crosspolymer	INACTIVE INGREDIENT	RSA9I561OK	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1
Methicone (20 cst)	INACTIVE INGREDIENT	6777U11MKT	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1
Microcrystalline Wax	INACTIVE INGREDIENT	XOF597Q3KY	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1
PEG-10 Dimethicone (600 cst)	INACTIVE INGREDIENT	8PR7V1SVM0	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1
PEG-30 Dipolyhydroxystearate	INACTIVE INGREDIENT	9713Q0S7FO	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1
Polyglyceryl-4 Isostearate	INACTIVE INGREDIENT	820DPX33S7	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1
Polyhydroxystearic Acid (2300 MW)	INACTIVE INGREDIENT	YXH47AOU0F	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1
Polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1
Stearyl Dimethicone (400 MPA.S AT 50C)	INACTIVE INGREDIENT	R327X197HY	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1
Tetrahexyldecyl Ascorbate	INACTIVE INGREDIENT	9LBV3F07AZ	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1
Triethoxycaprylylsilane	INACTIVE INGREDIENT	LDC331P08E	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1
Trolamine	INACTIVE INGREDIENT	9O3K93S3TK	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58892-418	COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	2	Current NDC, Legacy NDC, 2 package rows	20250406_885a674b-3457-4dfe-a801-529094b00499.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 11 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MEDICUBE PDRN SILKY SUNSCREEN	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	APR US INC	57154bec-6714-0314-e063-6294a90a4bd0	2026-07-20	Warnings	Exact identifier application number: M020
TOCOBO Double UV Defense Set	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	PICTON Co., Ltd.	56aff65a-aa08-dc3f-e063-6294a90acac3	2026-07-19	Warnings	Exact identifier application number: M020
THE SPORTO Invisible Sport for Body	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	Dune Suncare, Inc.	46564a09-909d-bcc7-e063-6294a90a627b	2026-07-17	Warnings	Exact identifier application number: M020
RR Sun Creme	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Undefined Inc	dc60b685-a7fc-47bb-ade9-44a8e3b54812	2026-07-17	Warnings	Exact identifier application number: M020
Cetaphil Tinted Daily Facial Moisturizer SPF 50	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Galderma Laboratories, L.P.	0ef2ebae-7198-47f4-8891-d1ca3cf54d4b	2026-07-16	Warnings	Exact identifier application number: M020
Mederma Scar Cream	AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE	PMI Branded Pharmaceuticals, Inc.	f9be5adb-dce3-4b17-939f-d80d486f2cb0	2026-07-16	Warnings	Exact identifier application number: M020
BaseLife Pure Mineral Shield Sunscreen	ZINC OXIDE	Wintech America, Inc.	7f741a91-6ed8-4d08-9196-d15527d044d5	2026-07-15	Warnings	Exact identifier application number: M020
BaseLife Clear UV Defense Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Wintech America, Inc.	128db446-93ba-4347-bd39-66177572c659	2026-07-15	Warnings	Exact identifier application number: M020
Biore Aqua Rich Facial Mist SPF 50	OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE	Kao USA Inc.	56a80a0d-b0b5-1098-e063-6294a90a5270	2026-07-15	Warnings	Exact identifier application number: M020
Anti Aging Lip Balm Pot SPF 15	LIP BALM	Epicuren Disocovery	4097e28a-ed11-e16a-e063-6294a90a5e9b	2026-07-14	Warnings	Exact identifier application number: M020
HolyCow Mineral Tallow Sunscreen Face and Body SPF 50	ZINC OXIDE	CALM ENTERPRISE LLC	722462d8-d2ab-44ce-9065-673ab2076269	2026-07-14	Warnings	Exact identifier application number: M020
X-Treme Cream Propolis Sunscreen SPF 45	X-TREME CREAM	Epicuren Discovery	3b29976e-eee0-b978-e063-6294a90accd6	2026-07-14	Warnings	Exact identifier application number: M020
Anti-Aging Lip Balm SPF 15	LIP BALM	Epicuren Discovery	3cbd0550-b6e5-3e86-e063-6394a90ac07f	2026-07-14	Warnings	Exact identifier application number: M020
Zinc Oxide Perfecting Sunscreen	ZINC OXIDE	Epicuren Discovery	1a0228f9-bf3f-a1fe-e063-6294a90a3fb5	2026-07-14	Warnings	Exact identifier application number: M020
Vacation Face	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Vacation INC.	14b8a3cf-031c-4c52-ba81-e683e69d0f37	2026-07-14	Warnings	Exact identifier application number: M020
Mederma Scar Cream	AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE	L. Perrigo Company	bd5c9df7-8dfb-4d20-9966-e148c5667b22	2026-07-14	Warnings	Exact identifier application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Watermelon Sugar PARADISO	AVOBENZONE, HOMOSALATE, OCTISALATE	Koco Life LLC	4081a4ad-b738-5fb6-e063-6394a90a9171	2026-07-13	Warnings	Exact identifier application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Coconut Cream PARADISO	AVOBENZONE, HOMOSALATE, OCTISALATE	Koco Life LLC	3cc5c1d8-91f8-8ad2-e063-6294a90a9229	2026-07-13	Warnings	Exact identifier application number: M020
Olay Super Serum Body Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	5513c5e2-3baf-2f09-e063-6394a90a495a	2026-07-13	Warnings	Exact identifier application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Peach Sky PARADISO	AVOBENZONE, HOMOSALATE, OCTISALATE	Koco Life LLC	3cc48592-f70d-664e-e063-6294a90ac6e8	2026-07-13	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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	Sample	Exclude flag	Status
58892-418-01	58892041801	1 TUBE in 1 CARTON (58892-418-01) / 100 g in 1 TUBE	1 tube	2012-03-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cotz Sensitive SPF 40 Sunscreen - Fallien Cosmeceuticals, LTD. \| Custom Analytics LLC \| Process Technologies & Packaging	Fallien Cosmeceuticals, LTD. \| Custom Analytics LLC \| Process Technologies & Packaging	2025-03-31	HUMAN OTC DRUG LABEL	2