Derma Pella Sunscreen Advance Cream-Gel

Product NDC
82160-726
11-digit product format
821600726
Labeler code
82160
Product ID
82160-726_2c494b27-5187-c3a8-e063-6394a90acd91
Type
HUMAN OTC DRUG
Nonproprietary name
Octocrylene, Avobenzone, Ethylhexyl Salicylate, Phenylbenzimidazole Sulfonic Acid, Polysilicone-15, Titanium Dioxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Pella Pharmaceuticals Co. Ltd
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-26
Substance
AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE; POLYSILICONE-15; TITANIUM DIOXIDE
Active strength
50; 20; 50; 100; 20; 16 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Derma Pella Sunscreen Advance Cream-Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE50 mg/g
ENSULIZOLE20 mg/g
OCTISALATE50 mg/g
OCTOCRYLENE100 mg/g
POLYSILICONE-1520 mg/g
TITANIUM DIOXIDE16 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, 9YQ9DI1W42, 4X49Y0596W, 5A68WGF6WM, F8DRP5BB29, 15FIX9V2JP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82160-726-01Derma Pella Sunscreen Advance Cream-Gel1 in 1 CARTONCREAM12
82160-726-01Derma Pella Sunscreen Advance Cream-Gel50 g in 1 TUBECREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82160-726DERMA PELLA SUNSCREEN ADVANCE CREAM-GEL (OCTOCRYLENE, AVOBENZONE, ETHYLHEXYL SALICYLATE, PHENYLBENZIMIDAZOLE SULFONIC ACID, POLYSILICONE-15, TITANIUM DIOXIDE) CREAM [PELLA PHARMACEUTICALS CO. LTD]2Current NDC, 2 package rows20250123_fe95fdbf-73df-a587-e053-6394a90a53a0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82160-726-01821600726011 TUBE in 1 CARTON (82160-726-01) / 50 g in 1 TUBE1 tube2022-12-26NoNoHistorical