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
2026-12-31
Current FDA listing
Yes

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 Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

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

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