Mineral Sunscreen

Product NDC
51326-125
11-digit product format
513260125
Labeler code
51326
Product ID
51326-125_b8f0c169-1a9d-455a-ad1c-e8e3a065661b
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide Titanium Dioxide
Dosage form
POWDER
Route
TOPICAL
Labeler
Topiderm, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-10-14
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
225; 240 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
Mineral Sunscreen
Brand name suffix
SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE225 mg/g
ZINC OXIDE240 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51326-125-05Mineral SunscreenSPF 504 g in 1 TUBEPOWDER43
51326-125-05Mineral SunscreenSPF 501 in 1 CARTONPOWDER13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51326-125MINERAL SUNSCREEN SPF 50 (ZINC OXIDE TITANIUM DIOXIDE) POWDER [TOPIDERM, INC.]3Current NDC, 2 package rows20241012_3a637542-0f79-47ae-815d-84d0036c737a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51326-125-05513260125051 TUBE in 1 CARTON (51326-125-05) / 4 g in 1 TUBE1 tube2020-10-14NoNoCurrent