Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50

Product NDC
81521-001
11-digit product format
815210001
Labeler code
81521
Product ID
81521-001_289b1fa4-87a1-05f4-e063-6294a90a70ee
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
Beautcella Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-01
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
88.5; 19.1 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE88.5 mg/mL
ZINC OXIDE19.1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81521-001-01Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF501 in 1 CARTONLOTION12
81521-001-01Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF5025 mL in 1 BOTTLE, PLASTICLOTION252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81521-001DERM INSTITUTE DAILY DEFENSE PROTECTION SUNSCREEN BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BEAUTCELLA INC.]2Current NDC, Legacy NDC, 2 package rows20241208_bad942d8-04da-31d2-e053-2a95a90a9275.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
81521-001-01815210001011 BOTTLE, PLASTIC in 1 CARTON (81521-001-01) / 25 mL in 1 BOTTLE, PLASTIC2021-05-010000-00-00NoNoCurrent