ProtecTINT 14N

Product NDC
59735-918
11-digit product format
597350918
Labeler code
59735
Product ID
59735-918_4f77c110-9e98-6fdf-e063-6394a90a3c7c
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octisalate, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
PML NYC, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-22
Substance
HOMOSALATE; OCTISALATE; ZINC OXIDE
Active strength
7; 5; 13.58 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
ProtecTINT 14N
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE7 g/100mL
OCTISALATE5 g/100mL
ZINC OXIDE13.58 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4X49Y0596W, V06SV4M95S, SOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59735-918-01ProtecTINT 14N35 mL in 1 TUBECREAM353
59735-918-02ProtecTINT 14N1 in 1 BOXCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59735-918PROTECTINT 20C (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 26W (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 32N (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 34C (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 58W (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 10N (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 24N (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 22W (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 30W (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 46N (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 42C (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 52N (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 14N (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 40W (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM [MANA PRODUCTS, INC.]1Current NDC, 2 package rows20240628_1bcc9f71-820f-eba2-e063-6394a90a3305.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59735-918-015973509180135 mL in 1 TUBE35 mlHistorical
59735-918-02597350918021 TUBE in 1 BOX (59735-918-02) / 35 mL in 1 TUBE (59735-918-01) 1 tube2023-11-22NoNoHistorical