Cotz Sensitive SPF 40

Product NDC: 58892-418
Requested package NDC: 58892-418-01
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 · 20 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	`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 3 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sunski Hot Block Mineral Sunscreen Stick SPF 50	ZINC OXIDE	Stewart Charley Ventures LLC dba Sunski	04ecc5e7-0d9e-4bc7-b964-4cbcc6ed06a8	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Anti Aging Insta Dry SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	7e48a3d2-e453-4733-b42b-8bea804cda59	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Anti Aging Lite SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	7204c24f-aab6-45eb-9bd4-879f715ba075	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Anti Aging Lite SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	7c1e780a-1831-4f49-a92e-e36017d241a2	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Cross Sport Insta Dry SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	d45614c8-b09c-417b-b691-082ea2149880	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Cross Sport Insta Dry SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	999b0b17-be73-4d42-b182-ce038f493301	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Cross Sport Insta Dry SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	adffff46-4cfb-4c0a-b1a6-75220ee193a5	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Cross Sport Insta Dry SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	13b2b45b-70e1-46ff-8555-48e1fe98c651	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Kids Insta Dry SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	5c2a5ca3-e9eb-48ba-8698-592d2c7aa241	2026-09-01	Warnings	Exact identifier application number: M020
Sunceutical SPF 50 Mineral Face Cream	ZINC OXIDE	Baxter Laboratories Pty. Ltd.	2c408728-a1de-d51e-e063-6294a90ade0b	2026-08-31	Warnings	Exact identifier application number: M020
SKIN1004 MADAGASCAR CENTELLA HYALU-CICA WATER-FIT SUN SERUM UV	BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENE	Craver Corporation	38d8c1c9-86b5-1edd-e063-6394a90aeb47	2026-08-30	Warnings	Exact identifier application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGEL	AVOBENZONE, HOMOSALATE, OCTISALATE	ISNTREE Inc.	5a3a17ff-a7fd-f707-e063-6394a90a3182	2026-08-29	Warnings	Exact identifier application number: M020
ISNTREE HYALURONIC ACID NATURAL SUNCREAM	ZINC OXIDE	ISNTREE Inc.	5a3a59b2-18b6-521b-e063-6294a90a2958	2026-08-29	Warnings	Exact identifier application number: M020
Cetaphil Daily Facial Moisturizer with suncreen SPF 35	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Galderma Laboratories, L.P.	f5eb347f-0d46-4de6-8f3f-9010327678ed	2026-08-28	Warnings	Exact identifier application number: M020
Utu Broad Spectrum SPF 30 Moisturizing Body Sunscreen	ZINC OXIDE	Utu Co	59938ace-c97c-d758-e063-6394a90a77e4	2026-08-28	Warnings	Exact identifier application number: M020
Utu Broad Spectrum SPF 30 Moisturizing Face Mineral Zinc Oxide Sunscreen Unscented	ZINC OXIDE	Utu Co	5982e790-7cdb-c96c-e063-6394a90a02d4	2026-08-28	Warnings	Exact identifier application number: M020
Utu Hydrating Sun Balm Broad Spectrum SPF 50	ZINC OXIDE	Utu Co	59d1d0ac-2444-d6f9-e063-6294a90ae80c	2026-08-28	Warnings	Exact identifier application number: M020
Hello Bello Mineral Sunscreen SPF 50	ZINC OXIDE	Topiderm, Inc.	54f12764-5c37-4a05-bf96-209fedb93fd1	2026-08-28	Warnings	Exact identifier application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGEL	AVOBENZONE, HOMOSALATE, OCTISALATE	ISNTREE Inc.	5a02c540-5b3b-9379-e063-6294a90a00f6	2026-08-27	Warnings	Exact identifier application number: M020
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50	SUNSCREEN SPF50	Guangzhou Meixi Biotechnology Co., Ltd.	5a0b4bd2-f6ad-35dc-e063-6294a90a8a66	2026-08-27	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