spf 50 mineral powder sunscreen

Product NDC
83369-001
11-digit product format
833690001
Labeler code
83369
Product ID
83369-001_4e572d00-4ae1-e800-e063-6294a90a1076
Type
HUMAN OTC DRUG
Nonproprietary name
titanium dioxide, zinc oxide
Dosage form
POWDER
Route
TOPICAL
Labeler
Smalls Brand LLC DBA Roe Wellness
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-13
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
23.9; 24.1 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
spf 50 mineral powder sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE23.9 g/100g
ZINC OXIDE24.1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83369-001-01spf 50 mineral powder sunscreen6 g in 1 CARTONPOWDER65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83369-001SPF 50 MINERAL POWDER SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [SMALLS BRAND LLC DBA ROE WELLNESS]3Current NDC, 1 package rows20241020_f8762dd1-0484-74ea-e053-6294a90ac112.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83369-001-01833690001016 g in 1 CARTON (83369-001-01) 6 g2023-04-13NoNoHistorical