Anhydrous SPF 30

Product NDC
59958-200
11-digit product format
599580200
Labeler code
59958
Product ID
59958-200_47e3761d-a093-fcff-e063-6294a90af25b
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Owen Biosciences, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-03-01
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
10.2; 3.7 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Anhydrous SPF 30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE10.2 g/100g
ZINC OXIDE3.7 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59958-200-02Anhydrous SPF 3030 g in 1 TUBECREAM304
59958-200-03Anhydrous SPF 3030 g in 1 TUBECREAM303
59958-200-01Anhydrous SPF 30100000 g in 1 DRUMCREAM1000002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JPANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
Titanium DioxideACTIVE INGREDIENT15FIX9V2JPANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
Titanium DioxideACTIVE INGREDIENT15FIX9V2JPANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
Titanium DioxideACTIVE MOIETY15FIX9V2JPANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
Titanium DioxideACTIVE MOIETY15FIX9V2JPANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
Titanium DioxideACTIVE MOIETY15FIX9V2JPANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
Zinc OxideACTIVE MOIETYSOI2LOH54ZANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
Zinc OxideACTIVE MOIETYSOI2LOH54ZANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
Zinc OxideACTIVE MOIETYSOI2LOH54ZANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
CyclomethiconeINACTIVE INGREDIENTNMQ347994ZANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
CyclomethiconeINACTIVE INGREDIENTNMQ347994ZANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
FERRIC OXIDE BlackINACTIVE INGREDIENTXM0M87F357ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
FERRIC OXIDE BlackINACTIVE INGREDIENTXM0M87F357ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
TribeheninINACTIVE INGREDIENT8OC9U7TQZ0ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
TribeheninINACTIVE INGREDIENT8OC9U7TQZ0ANHYDROUS 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
59958-200ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]3Current NDC, Legacy NDC, 1 package rows20241105_0cc8221d-5ec5-4abf-a4f5-ab06e8dcea68.zip
59958-200ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_1510cae2-9c8f-45ba-b088-67747af3d30c.zip
59958-200ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]2Current NDC, Legacy NDC, 1 package rows20220423_6f56e04f-6d90-41e4-976e-e2e98dfbc98c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59958-200-0159958020001100000 g in 1 DRUM (59958-200-01) 100000 g2021-01-010000-00-00NoNoCurrent
59958-200-025995802000230 g in 1 TUBE (59958-200-02) 30 g2015-01-010000-00-00NoNoCurrent
59958-200-035995802000330 g in 1 TUBE (59958-200-03) 30 g2011-03-010000-00-00NoNoCurrent