FDA.reportPublic FDA data

Cotz Sensitive SPF 40

Product NDC
58892-418
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
2027-12-31
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 · 40 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58892-418-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58892-418-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58892-418-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58892-418-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58892-418-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58892-418-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58892-418-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58892-418-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58892-418-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58892-418-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage58892-418-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage58892-418-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage58892-418-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage58892-418-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage58892-418-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage58892-418-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage58892-418-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage58892-418-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage58892-418-019bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage58892-418-01110d247fa046…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
2027-12-31

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 310 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lancome Paris Absolue Bx Makeup Broad Spectrum SPF 18 Sunscreen Absolute Replenishing Radiant Makeup Normal to Dry SkinOCTINOXATEL'Oreal USA Products Inca45fef28-5dde-48b2-b7c0-ede694f4c32b2023-12-30WarningsExact identifier
application number: M020
it cosmetics Bye Bye Foundation Full Coverage Moisturizer Broad Spectrum 50 Plus Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC34f0c2c9-a5bc-4b25-bfc1-336dcbb353e42023-12-30WarningsExact identifier
application number: M020
Kiehls Since 1851 Ultra Facial Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Incfb9daea3-c249-417c-ad34-3e89f31185592023-12-30WarningsExact identifier
application number: M020
Kiehls Since 1851 Broad Spectrum SPF 30 Sunscreen Powerful Wrinkle ReducingAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc3f58b258-b954-41f0-93ad-f6c9fe25718d2023-12-30WarningsExact identifier
application number: M020
Kiehls Since 1851 Activated Sun Protector Broad Spectrum SPF 30 Sunscreen Water Resistant 80 MInutesAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Inc2d2fbd8b-a90f-465a-9bf3-75cd6abdc6d32023-12-30WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift MultiAction Ultra Firming and Dark Spot Correcting Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incbf0e22df-4043-407f-a930-29595da1bdf62023-12-30WarningsExact identifier
application number: M020
Kiehls Since 1851 Activated Sun Protector Broad Spectrum SPF 50 Sunscreen Water Resistant 80 MInutesAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Inc04fd0839-5046-4633-a919-6b7b6bea4f3e2023-12-30WarningsExact identifier
application number: M020
Kiehls Since 1851 Dermatologist Solutions Super Fluid Daily UV Defense Broad Spectrum SPF 50 plus Sunscreen Antipollution Lightweight FormulaAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inc.ed138c48-d542-4522-a23c-1b586aad11272023-12-30WarningsExact identifier
application number: M020
Kiehls Since 1851 Ultra Facial Moisturizer Broad Spectrum SPF 30 Sunscreen For All Skin TypesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incd1a8c8d2-59d2-4389-9369-5f9b053a956e2023-12-30WarningsExact identifier
application number: M020
Lancome Paris Visionnaire Broad Spectrum SPF 20 Sunscreen Advanced Multi Correcting All Skin TypesAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc43041108-6adb-4dd3-a75f-87f5d643c7942023-12-30WarningsExact identifier
application number: M020
Lancome Paris Bienfait MultiVital Eye Broad Spectrum SPF 30 SunscreenAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc449a6027-4d0d-40e1-af58-3553071d6fdf2023-12-30WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Wintergreen SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.baff2dfe-fd0b-0709-e053-2a95a90a431b2023-12-29WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Wintergreen SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb013e70-f081-f8f2-e053-2995a90a19812023-12-29WarningsExact identifier
application number: M020
Loreal Paris Age Perfect Rosy Tone SPF 30 Renew and revive healthy tone Visibly younger-looking skinAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc1c83726b-f8ff-48d5-bf30-bc75e3fb149d2023-12-29WarningsExact identifier
application number: M020
LOreal Paris True Match Lumi Healthy Luminous Makeup Broad Spectrum SPF 20OCTINOXATEL'Oreal USA Products Inccf39375c-de44-47de-bf15-fce4dfad8c742023-12-29WarningsExact identifier
application number: M020
Loreal Paris Age Perfect Radiant Serum foundation SPF 50HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc06a94c28-bfb7-4842-a463-459205477cd82023-12-29WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30 - PEACHES N SOLZINC OXIDE SUNSCREENBentley Laboratories, LLCe7c9c914-9972-4b55-a49d-cbc8ce0756472023-12-29WarningsExact identifier
application number: M020
LOREAL PARIS REVITALIFT ANTI WRINKLE FIRMING MOISTURIZER SPF 25AVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc8840da10-63cb-47ea-ad46-1ae6df1639e82023-12-29WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30 - PINK SUNRISEZINC OXIDE SUNSCREENBentley Laboratories, LLC289fb410-7884-4bc4-a25b-963de1cc3a702023-12-29WarningsExact identifier
application number: M020
LOreal Paris Infallible ProGlow Broad Spectrum SPF 15 SunscreenOCTINOXATEL'Oreal USA Products Inc82a6fbba-f0d4-475f-9ba7-615118eed70d2023-12-29WarningsExact 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