Dermatone Mineral SPF 30

Product NDC
54414-030
11-digit product format
544140030
Labeler code
54414
Product ID
54414-030_4b210203-6e23-22c6-e063-6394a90a88c9
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide 20%
Dosage form
LOTION
Route
TOPICAL
Labeler
Dermatone Labs LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-21
Substance
ZINC OXIDE
Active strength
20 g/100mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dermatone Mineral SPF 30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54414-030-02Dermatone Mineral SPF 3089 mL in 1 CONTAINERLOTION893
54414-030-03Dermatone Mineral SPF 3059 mL in 1 CONTAINERLOTION593

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54414-030-025441400300289 mL in 1 CONTAINER (54414-030-02) 89 ml2025-08-21NoNoCurrent
54414-030-035441400300359 mL in 1 CONTAINER (54414-030-03) 59 ml2025-08-21NoNoCurrent