BELASOL Sun Cream Non-Tinted Moisturizing SPF 50

Product NDC
83789-434
11-digit product format
837890434
Labeler code
83789
Product ID
83789-434_09b53878-59e1-2326-e063-6294a90aa3a4
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
EK Clothing LLC dba Belasol
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-20
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
20; 170 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BELASOL Sun Cream Non-Tinted Moisturizing SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE20 mg/mL
ZINC OXIDE170 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83789-434-00BELASOL Sun Cream Non-Tinted Moisturizing SPF 50118.3 mL in 1 TUBECREAM118.31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83789-434BELASOL SUN CREAM NON-TINTED MOISTURIZING SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [EK CLOTHING LLC DBA BELASOL]1Current NDC, 1 package rows20231120_fb677ad0-2791-44ec-9720-951471ec009a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83789-434-0083789043400118.3 mL in 1 TUBE (83789-434-00) 118.3 ml2023-11-20NoNoHistorical