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 9 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Continuous Correction Cream	HOMOSALATE 10% OCTISALATE 4.9% OCTOCRYLENE 4%	Baxter of California, LLC	14b05c8c-0398-2973-e063-6394a90a8a86	2026-07-31	Warnings	Exact identifier application number: M020
Cover Creme	TITANIUM DIOXIDE	Baxter of California	31f5e8c4-523f-4596-e063-6294a90a6a12	2026-07-31	Warnings	Exact identifier application number: M020
MELAO GHK-Cu PEPTIDE SUNSCREEN	BUTYL METHOXYDIBENZOYLMETHANE,ETHYLHEXYL SALICYLATE,HOMOSALATE,OCTOCRYLENE	Guangdong Aimu Biological Technology Co., Ltd	57a8c34a-d6c9-c03e-e063-6394a90a7af1	2026-07-29	Warnings	Exact identifier application number: M020
BelleJoss BROAD SPECTRUM SPF 50	BROAD SPECTRUM SPF 50	Guangzhou Liyan Cosmetics Technology Co., Ltd.	57c07f29-2e23-d18a-e063-6394a90a1020	2026-07-29	Warnings	Exact identifier application number: M020
BemeJolie BROAD SPECTRUM SPF 50	BROAD SPECTRUM SPF 50	Guangzhou Liyan Cosmetics Technology Co., Ltd.	57c27cea-bb0c-5d2d-e063-6394a90a1b48	2026-07-29	Warnings	Exact identifier application number: M020
DeFlame	ALLANTOIN	Noon Aesthetics M.R. Ltd	2628bd73-0ca9-497b-bcd9-088444cd62be	2026-07-28	Warnings	Exact identifier application number: M020
Native Mineral Suncare Broad Spectrum SPF 30 Unscented	ZINC OXIDE	The Procter & Gamble Manufacturing Company	3a89238b-d1ee-d7fa-e063-6294a90ae55f	2026-07-28	Warnings	Exact identifier application number: M020
First Aid Beauty FAB Mineral Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	The Procter & Gamble Manufacturing Company	dfb1b42e-c821-1a41-e053-2995a90acf95	2026-07-28	Warnings	Exact identifier application number: M020
HEB 50 Pumpkin Spice Latte Scent Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B.	579f3274-398e-7eab-e063-6394a90afe35	2026-07-27	Warnings	Exact identifier application number: M020
LUXE COLOR FOUNDATION	OCTINOXATE 7% ZINC OXIDE 5%	Guangzhou Huixue Biotechnology Co., Ltd.	576c3496-702f-808c-e063-6394a90a53c3	2026-07-25	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25 Kit	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Xact Packing Limited	5759058d-e683-f3fc-e063-6394a90abc01	2026-07-24	Warnings	Exact identifier application number: M020
No7 Future Renew Defense Shield SPF 50	AVOBENZONE, OCTINOXATE, OCTISALATE	Xact Packing Limited	5758b79f-6386-bbea-e063-6394a90aeb34	2026-07-24	Warnings	Exact identifier application number: M020
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-C	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	BEL STAR S.A.	575fb2c3-e332-8a3b-e063-6394a90a9fd9	2026-07-24	Warnings	Exact identifier application number: M020
SERVE AND PRIME SUNSCREEN BROAD SPECTRUM SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	ESTEE LAUDER INC	575fc04a-794a-93e7-e063-6394a90a7e67	2026-07-24	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHT	ZINC OXIDE	Younique, LLC	f93d42a9-b655-4b75-a16d-b29f38f04efc	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHT MEDIUM	ZINC OXIDE	Younique, LLC	82769819-b229-4864-9b3c-44f49a68a53a	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIR	ZINC OXIDE	Younique, LLC	ed700cae-8226-48d9-93ba-03154aa1cae5	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIR LIGHT	ZINC OXIDE	Younique, LLC	d728b89c-692f-485b-88c3-929b2f0350d5	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUM	ZINC OXIDE	Younique, LLC	a49dfff1-e9ec-4573-90b0-ef6a7226aa56	2026-07-23	Warnings	Exact identifier application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUM DARK	ZINC OXIDE	Younique, LLC	cc576b63-caf4-491d-8d7f-027b1127133b	2026-07-23	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