Cream Oil Sunscreen

Product NDC
59958-408
11-digit product format
599580408
Labeler code
59958
Product ID
59958-408_2630ac67-a827-30c9-e063-6394a90a3561
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide, Titanium Dioxide Sunscreen
Dosage form
CREAM
Route
TOPICAL
Labeler
Owen Biosciences, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-04-04
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
1.25; 21 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cream Oil Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE1.25 g/100g
ZINC OXIDE21 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59958-408-01Cream Oil Sunscreen50 g in 1 TUBECREAM504
59958-408-02Cream Oil Sunscreen1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59958-408CREAM OIL SUNSCREEN (ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN) CREAM [OWEN BIOSCIENCES, INC.]4Current NDC, Legacy NDC, 2 package rows20241107_b2ccdfea-1c27-42af-b9d8-752e9f91ae87.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59958-408-015995804080150 g in 1 TUBE50 gHistorical
59958-408-02599580408021 TUBE in 1 CARTON (59958-408-02) / 50 g in 1 TUBE (59958-408-01) 1 tube2020-04-040000-00-00NoNoCurrent