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 76 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	824c5f13-970e-4e9e-8f2a-2a01973d2e59	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b7621ef5-47fc-4ccc-aedd-eac328ace7b9	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3C Cool	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	64a29ff8-e24d-4818-9b54-734a0eb2a13f	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2WP Warm Peach	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	17a0201b-b797-4e65-838f-1ce8d408a020	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2WO Warm Olive	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	72e2c71a-da1d-497f-a8b7-491cff951c63	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3CR Cool Fosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	19d1432a-96b0-4cef-b13e-895dd41b41d6	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5a06c820-ccd8-47ce-8bbf-7e90da92b1de	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	205e195a-fd30-44f7-9294-e701f0f766d6	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3WP Warm Peach	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5495ff75-0c83-4491-8af7-4aed7a779d7f	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3WO Warm Olive	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	10bc345d-a5b1-4b70-bfa6-a2d7816904bf	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	30268b6e-d42a-4314-b82f-24f9e81cca2a	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4,5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	545c962f-2a59-4d94-8fef-ebdba4127f42	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4C Cool	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	17c9226b-459c-42fe-ac50-7e26db6b49af	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	8cb27c4e-b2f4-4e60-a5ff-7cdda79a3af6	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	bf323e10-5479-44b3-b4b9-b8ca6b0f7688	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4WO Warm Olive	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	2d6a5133-b847-4ecf-8c33-1cb05aca6b91	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4WP Warm Peach	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	275be888-2c52-43ed-846a-55525002edcd	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6,5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c73576a6-dbab-4205-add5-876a060b5022	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 7,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	4ae761ac-df06-4913-a8bf-8ca1be32b5b7	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	72c45120-6997-4250-b9b4-1cdb762efe1a	2026-01-16	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