FDA.reportPublic FDA data

Sente Daily Repair Complex

Product NDC
59958-220
11-digit product format
599580220
Labeler code
59958
Product ID
59958-220_c718a976-2b04-2b33-e053-2a95a90a4800
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Owen Biosciences, Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-04-02
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
10 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59958-220IInactivated by FDA2026-10-15
excluded packagepackage59958-22059958-220-02IInactivated by FDA2026-10-15

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59958-220-022021-07-14C16284748780-1ba0f9c33-13ce-a910-e053-dadaa90a0b85Sente Daily Repair Complex
59958-220-022021-01-29C16284748780-1ba0f9c33-13ce-a910-e053-dadaa90a0b85Sente Daily Repair Complex

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59958-220-01Sente Daily Repair ComplexSPF 3030 g in 1 BOTTLE, PUMPCREAM305
59958-220-02Sente Daily Repair ComplexSPF 301 in 1 BOXCREAM15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JPSENTE DAILY REPAIR COMPLEX SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZSENTE DAILY REPAIR COMPLEX SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
Titanium DioxideACTIVE MOIETY15FIX9V2JPSENTE DAILY REPAIR COMPLEX SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
Zinc OxideACTIVE MOIETYSOI2LOH54ZSENTE DAILY REPAIR COMPLEX SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
CALCIUM BEHENATEINACTIVE INGREDIENTJ5VFA9V6YGSENTE DAILY REPAIR COMPLEX SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)INACTIVE INGREDIENTUF7620L1W6SENTE DAILY REPAIR COMPLEX SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)INACTIVE INGREDIENT9E4CO0W6C5SENTE DAILY REPAIR COMPLEX SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SENTE DAILY REPAIR COMPLEX SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSENTE DAILY REPAIR COMPLEX SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
MELANIN SYNTHETIC (TYROSINE, PEROXIDE)INACTIVE INGREDIENTO0CV1RMR44SENTE DAILY REPAIR COMPLEX SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
METHICONE (20 CST)INACTIVE INGREDIENT6777U11MKTSENTE DAILY REPAIR COMPLEX SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMERINACTIVE INGREDIENTEG97988M5QSENTE DAILY REPAIR COMPLEX SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
PEG-10 DIMETHICONE (600 CST)INACTIVE INGREDIENT8PR7V1SVM0SENTE DAILY REPAIR COMPLEX SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
SORBITAN ISOSTEARATEINACTIVE INGREDIENT01S2G2C1E4SENTE DAILY REPAIR COMPLEX SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
TRIBEHENININACTIVE INGREDIENT8OC9U7TQZ0SENTE DAILY REPAIR COMPLEX SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSENTE DAILY REPAIR COMPLEX SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59958-220SENTE DAILY REPAIR COMPLEX SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]5Legacy NDC, 2 package rows20241106_c7ef88d4-14bf-444b-a9d8-58455b5bbe7b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59958-220-015995802200130 g in 1 BOTTLE, PUMP30 gHistorical
59958-220-02599580220021 BOTTLE, PUMP in 1 BOX (59958-220-02) > 30 g in 1 BOTTLE, PUMP (59958-220-01) 2015-04-020000-00-00NoNoCurrent