FDA.reportPublic FDA data

Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50

Product NDC
83789-573
11-digit product format
837890573
Labeler code
83789
Product ID
83789-573_299554b9-8ed3-d33e-e063-6394a90a57b5
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
2024-11-25
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 Suncream Non Tinted Moisturizing Sunscreen 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
83789-573-00Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50100 mL in 1 TUBECREAM1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83789-573BELASOL SUNCREAM NON TINTED MOISTURIZING SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [EK CLOTHING LLC DBA BELASOL]1Current NDC, 1 package rows20241228_f22626c1-0996-41d8-a2ec-3bf7491df657.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83789-573-0083789057300100 mL in 1 TUBE (83789-573-00) 100 ml2024-11-25NoNoCurrent