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 151 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Everyday Humans Sunscreen Lip Balm Broad Spectrum SPF30	LIP BALM SPF30	Everyday Group Limted	2d42034a-4ada-57cf-e063-6394a90a0b5f	2025-12-04	Warnings	Exact identifier application number: M020
Ciele SPF 30 prime PROTECT Broad Spectrum SPF 30 Sunscreen	SUNSCREEN 30 MINERAL	LE COSMETICS INC	3bb54b93-0ab2-2ecc-e063-6394a90acac3	2025-12-04	Warnings	Exact identifier application number: M020
Good Times SPF 50 Sunscreen	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	EVERYDAY GROUP LIMITED	f40c6c4a-47a2-5dfe-e053-2995a90a3df3	2025-12-04	Warnings	Exact identifier application number: M020
Sheer Guard Natural Mineral Sunscreen	ZINC OXIDE	EVERYDAY GROUP LIMITED	3257719d-dcc6-7ac5-e063-6294a90aafcd	2025-12-04	Warnings	Exact identifier application number: M020
Sun Glazed SPF 30 Sunscreen Glow Oil	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	EVERYDAY GROUP LIMITED	dba8075b-be36-4787-b23d-942d0e792aa8	2025-12-04	Warnings	Exact identifier application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 Deep	ZINC OXIDE	Crunchi, LLC.	0dc478e0-9555-4ce6-b448-7d58e3a6bae0	2025-12-04	Warnings	Exact identifier application number: M020
Solbar Shield SPF40	SOLBAR SHIELD SPF40	Person and Covey	bd3a9a94-fc87-4127-abf9-29e56ac9ce5d	2025-12-04	Warnings	Exact identifier application number: M020
Solbar Thirty SPF 30	SOLBAR THIRTY SPF30	Person and Covey	ab9ac056-61d9-43d5-a3db-2d487897cc69	2025-12-04	Warnings	Exact identifier application number: M020
Solbar Fifty SPF50	SOLBAR FIFTY SPF50	Person and Covey	41fd3844-181c-4cb2-8379-f313104351ef	2025-12-04	Warnings	Exact identifier application number: M020
Solbar Avo SPF35	SOLBAR AVO SPF35	Person and Covey	bfe1e828-76d4-4db3-a8ba-b54b31baacad	2025-12-04	Warnings	Exact identifier application number: M020
Banana Boat Sport Ultra Broad Spectrum SPF 50 Plus Sunscreen Lip Balm	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	c7a3c03b-7fee-404c-e053-2a95a90a3a97	2025-12-04	Warnings	Exact identifier application number: M020
Poolside Bronze Service Instant bronzing lotion. SPF30	HOMOSALATE,OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	4524129b-f8aa-171b-e063-6294a90aeebe	2025-12-04	Warnings	Exact identifier application number: M020
Solbar Zinc SPF38	SOLBAR ZINC SPF38	Person and Covey	fac62a2f-92ee-4afd-9999-bc5011159e43	2025-12-04	Warnings	Exact identifier application number: M020
elf Sun Boss Gloss SPF 25 Sunscreen Pink Me Girl	ZINC OXIDE	e.l.f. Cosmetics, Inc.	6c316ce4-c2f6-4633-a789-e786d0f76abd	2025-12-04	Warnings	Exact identifier application number: M020
Poolside Frostbite Sunscreen coconut SPF 15 Scented lip gloss	HOMOSALATE, OCTOCRYLENE, OCTISALATE , AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	452b5f2c-b61f-8915-e063-6294a90ac911	2025-12-04	Warnings	Exact identifier application number: M020
Poolside Frostbite Sunscreen watermelon SPF 15 Scented lip gloss	HOMOSALATE , OCTOCRYLENE, OCTISALATE, AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	452b6e12-1bf9-8093-e063-6394a90a9e74	2025-12-04	Warnings	Exact identifier application number: M020
Poolside Frostbite Sunscreen Papaya SPF 15 Scented lip gloss	HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	452b6f22-5080-86ab-e063-6394a90a0416	2025-12-04	Warnings	Exact identifier application number: M020
Poolside Golden Hour SPF15 sunscreen lip oil	HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	452b8393-1887-a660-e063-6394a90a4c2b	2025-12-04	Warnings	Exact identifier application number: M020
Poolside Sun Daze Body Illuminator SPF 30 shimmer sunscreen gel	HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	452b8dde-dd63-b585-e063-6394a90a3543	2025-12-04	Warnings	Exact identifier application number: M020
Binda Botanicals Baby and Kids Sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	452b9b7d-4049-b483-e063-6394a90a5358	2025-12-04	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