Hybrid SPF

Product NDC
51326-128
11-digit product format
513260128
Labeler code
51326
Product ID
51326-128_6e898b78-e4b8-4cad-a2a0-b3b05ebcffab
Type
HUMAN OTC DRUG
Nonproprietary name
Octocrylene, Octisalate, Zinc Oxide
Dosage form
SPRAY
Route
TOPICAL
Labeler
Topiderm, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-07
Substance
OCTISALATE; OCTOCRYLENE; ZINC OXIDE
Active strength
50; 80; 50 mg/mL; mg/mL; 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
Hybrid SPF
Brand name suffix
SPF 30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE50 mg/mL
OCTOCRYLENE80 mg/mL
ZINC OXIDE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4X49Y0596W, 5A68WGF6WM, SOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51326-128-01Hybrid SPFSPF 30177 mL in 1 CANSPRAY1772

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51326-128-0151326012801177 mL in 1 CAN (51326-128-01) 177 ml2024-10-07NoNoCurrent