HYDRASHEER MINERAL SUNSCREEN

Product NDC
84436-0001
11-digit product format
844360001
Labeler code
84436
Product ID
84436-0001_47d45442-fc33-d77a-e063-6394a90af415
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
THE OUTSET GROUP LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-24
Substance
ZINC OXIDE
Active strength
149.3 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HYDRASHEER MINERAL SUNSCREEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE149.3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84436-0001-1HYDRASHEER MINERAL SUNSCREEN50 mL in 1 BOTTLE, PUMPLOTION503
84436-0001-2HYDRASHEER MINERAL SUNSCREEN1 in 1 BOXLOTION13
84436-0001-3HYDRASHEER MINERAL SUNSCREEN5 mL in 1 TUBELOTION53
84436-0001-4HYDRASHEER MINERAL SUNSCREEN1 in 1 BOXLOTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84436-0001HYDRASHEER MINERAL SUNSCREEN (ZINC OXIDE) LOTION [THE OUTSET GROUP LLC]2Current NDC, 4 package rows20241127_1b282bcf-58e2-d285-e063-6394a90a5b87.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84436-0001-18443600010150 mL in 1 BOTTLE, PUMP50 mlHistorical
84436-0001-2844360001021 BOTTLE, PUMP in 1 BOX (84436-0001-2) / 50 mL in 1 BOTTLE, PUMP (84436-0001-1) 2024-06-24NoNoHistorical
84436-0001-3844360001035 mL in 1 TUBE5 mlHistorical
84436-0001-4844360001041 TUBE in 1 BOX (84436-0001-4) / 5 mL in 1 TUBE (84436-0001-3) 1 tube2024-06-24NoNoHistorical