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 dateSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05110d247fa046…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
IngredientStrength
ZINC OXIDE200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
885a674b-3457-4dfe-a801-529094b00499Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58892-418-012025-04-02C16284748780-19855d018-e4b6-cd31-e053-dbdaa90ab51a885a674b-3457-4dfe-a801-529094b00499
58892-418-012019-11-27C16284748780-19855d018-e4b6-cd31-e053-dbdaa90ab51a885a674b-3457-4dfe-a801-529094b00499

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-418-01Cotz Sensitive SPF 40 Sunscreen100 g in 1 TUBELOTION1002
58892-418-01Cotz Sensitive SPF 40 Sunscreen1 in 1 CARTONLOTION12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZCOTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]1
Zinc OxideACTIVE MOIETYSOI2LOH54ZCOTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]1
.Alpha.-Tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L0COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]1
Alkyl (C12-15) BenzoateINACTIVE INGREDIENTA9EJ3J61HQCOTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]1
Caprylhydroxamic AcidINACTIVE INGREDIENTUPY805K99WCOTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]1
Caprylyl GlycolINACTIVE INGREDIENT00YIU5438UCOTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]1
Cetyl PEG/PPG-10/1 Dimethicone (HLB 5)INACTIVE INGREDIENT035JKJ76MTCOTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]1
Cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0RCOTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]1
Cyclomethicone 6INACTIVE INGREDIENTXHK3U310BACOTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]1
Dimethicone 100INACTIVE INGREDIENTRO266O364UCOTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]1
Dimethicone/Diene Dimethicone CrosspolymerINACTIVE INGREDIENTRSA9I561OKCOTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KCOTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]1
Methicone (20 cst)INACTIVE INGREDIENT6777U11MKTCOTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]1
Microcrystalline WaxINACTIVE INGREDIENTXOF597Q3KYCOTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]1
PEG-10 Dimethicone (600 cst)INACTIVE INGREDIENT8PR7V1SVM0COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]1
PEG-30 DipolyhydroxystearateINACTIVE INGREDIENT9713Q0S7FOCOTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]1
Polyglyceryl-4 IsostearateINACTIVE INGREDIENT820DPX33S7COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]1
Polyhydroxystearic Acid (2300 MW)INACTIVE INGREDIENTYXH47AOU0FCOTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]1
Polysorbate 20INACTIVE INGREDIENT7T1F30V5YHCOTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XCOTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]1
Stearyl Dimethicone (400 MPA.S AT 50C)INACTIVE INGREDIENTR327X197HYCOTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]1
Tetrahexyldecyl AscorbateINACTIVE INGREDIENT9LBV3F07AZCOTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]1
TriethoxycaprylylsilaneINACTIVE INGREDIENTLDC331P08ECOTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]1
TrolamineINACTIVE INGREDIENT9O3K93S3TKCOTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]1
WaterINACTIVE INGREDIENT059QF0KO0RCOTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-418COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]2Current NDC, Legacy NDC, 2 package rows20250406_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 71 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 241HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.a100b05a-06b7-4c65-9822-3f62ca029f402026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 331HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.c3dd293c-8819-4406-af60-41b632a8c00f2026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 342HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.99a92fc5-9a3e-434a-9a5b-3cc47efeea532026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 351HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.e6cd9c7a-29ef-4132-a3e5-575dddb36a9e2026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 421HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.ea630f2c-49a7-4900-a0ac-b0e1c554aff92026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 430HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.cc9c9b69-a0ea-44ac-a590-2cd241ce31622026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 442HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.e38a10a8-73ac-4fc5-bbde-537ccb845e6f2026-01-22WarningsExact identifier
application number: M020
Designer Lip Smoothie SPF 15 Lip BalmAVOBENZONE, OCTISALATE, HOMOSALATE, PETROLATUMAustralian Gold6fd1bd4f-ef94-42b5-a26c-2a02718c113f2026-01-22WarningsExact identifier
application number: M020
Australian Gold SPF 15 Lip BalmOCTINOXATE, OCTOCRYLENE, OXYBENZONE, OCTISALATE, PETROLEUM JELLYAustralian Gold92966c2d-b61a-4f8b-a5c1-8dfb6352c82f2026-01-22WarningsExact identifier
application number: M020
LEBELAGE UV SUN ULTRA SHIELD SUN SCREENLOTION 50gAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OCTISALATEDONGDONGGURIMOO CO.,LTD.4907eb9c-3978-27ed-e063-6394a90a9f662026-01-22WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.be9f7608-cfaa-4b16-83dd-0580047af56c2026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 15COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.6b27df44-c441-4ae8-a1b0-a9cf2fff6f212026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.3c295f6b-6202-a2e1-e063-6394a90a9a602026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 19COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.b2eee48f-b644-403c-a57e-04a1491bc3862026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.ebcc2c6c-a039-48d5-8c1c-5b347254c4c22026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.6967f8bc-3092-44a9-926a-6c11676425e52026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.37d4d8c1-e76b-48a3-9a13-f0543af1b28f2026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 24WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.fa5046f2-a6db-4ac3-a78f-1b5df075d7e82026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.0c5fc63f-1899-4406-944a-1cdcdf8b42772026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.58a84ecd-3f27-40fc-8e0b-e29192679e6b2026-01-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58892-418-01588920418011 TUBE in 1 CARTON (58892-418-01) / 100 g in 1 TUBE1 tube2012-03-30NoNoCurrent