Dermaka Sunscreen SPF 42, Tinted

Product NDC
82240-619
11-digit product format
822400619
Labeler code
82240
Product ID
82240-619_37b123bf-b595-e935-e063-6394a90a6dd0
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
DERMAKA SKIN PRODUCTS
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-03
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
60; 77 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
Dermaka Sunscreen SPF 42, Tinted
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE60 mg/mL
ZINC OXIDE77 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82240-619-00Dermaka Sunscreen SPF 42, Tinted5 mL in 1 PACKETCREAM51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82240-619-00822400619005 mL in 1 PACKET (82240-619-00) 5 ml2025-06-03NoNoHistorical