FDA.reportPublic FDA data

Mineral Lip Sunscreen

Product NDC
85492-212
11-digit product format
854920212
Labeler code
85492
Product ID
85492-212_45ff88cb-2885-477a-e063-6294a90a9305
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
STICK
Route
TOPICAL
Labeler
The Essential Brazilian Spa LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-17
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
40; 55 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 Lip Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE40 mg/g
ZINC OXIDE55 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85492-212-14Mineral Lip Sunscreen1 in 1 CARTONSTICK12
85492-212-14Mineral Lip Sunscreen4.5 g in 1 CYLINDERSTICK4.52
85492-212-45Mineral Lip Sunscreen4.5 g in 1 CYLINDERSTICK4.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85492-212MINERAL LIP SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) STICK [THE ESSENTIAL BRAZILIAN SPA LLC]1Current NDC, 1 package rows20250519_35442ac0-c361-e08f-e063-6294a90a5cb2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85492-212-14854920212141 CYLINDER in 1 CARTON (85492-212-14) / 4.5 g in 1 CYLINDER1 cylinder2025-07-07NoNoHistorical
85492-212-45854920212454.5 g in 1 CYLINDER (85492-212-45) 4.5 g2023-04-17NoNoHistorical