FDA.reportPublic FDA data

APRILSKIN MUGWORT CALMING SUNSCREEN

Product NDC
82440-300
11-digit product format
824400300
Labeler code
82440
Product ID
82440-300_50a7b64a-8b27-97ac-e063-6294a90ad77a
Type
HUMAN OTC DRUG
Nonproprietary name
Octocrylene, Homosalate, Octisalate, Avobenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
APR US INC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-04
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
2.85; 7; 4.5; 9 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
APRILSKIN MUGWORT CALMING SUNSCREEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE2.85 g/100mL
HOMOSALATE7 g/100mL
OCTISALATE4.5 g/100mL
OCTOCRYLENE9 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82440-300-01APRILSKIN MUGWORT CALMING SUNSCREEN1 in 1 BOXLOTION11
82440-300-01APRILSKIN MUGWORT CALMING SUNSCREEN50 mL in 1 TUBELOTION501
82440-300-03APRILSKIN MUGWORT CALMING SUNSCREEN1 in 1 BOXLOTION11
82440-300-03APRILSKIN MUGWORT CALMING SUNSCREEN15 mL in 1 TUBELOTION151

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82440-300-01824400300011 TUBE in 1 BOX (82440-300-01) / 50 mL in 1 TUBE1 tube2026-05-04NoNoHistorical
82440-300-03824400300031 TUBE in 1 BOX (82440-300-03) / 15 mL in 1 TUBE1 tube2026-05-04NoNoHistorical