FDA.reportPublic FDA data

CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 CORAL CREAMY

Product NDC
14141-309
11-digit product format
141410309
Labeler code
14141
Product ID
14141-309_3ce46bfb-8d6d-05f6-e063-6394a90aac2f
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, ZINC OXIDE
Dosage form
STICK
Route
TOPICAL
Labeler
BEL STAR S A
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-07
Substance
OCTINOXATE; ZINC OXIDE
Active strength
25; 39.2 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 CORAL CREAMY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE25 mg/g
ZINC OXIDE39.2 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z, 4Y5P7MUD51

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14141-309-01CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 CORAL CREAMY3 g in 1 TUBESTICK34
14141-309-01CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 CORAL CREAMY1 in 1 CARTONSTICK14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14141-309CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 CORAL CREAMY (OCTINOXATE, ZINC OXIDE) STICK CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 FUCHSIA CREAMY (OCTINOXATE, ZINC OXIDE) STICK CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 PINK CREAMY (OCTINOXATE, ZINC OXIDE) STICK CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 NUDE CREAMY (OCTINOXATE, ZINC OXIDE) STICK CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 CHERRY CREAMY (OCTINOXATE, ZINC OXIDE) STICK CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 BERRY CREAMY (OCTINOXATE, ZINC OXIDE) STICK [BEL STAR S A]3Current NDC, Legacy NDC, 2 package rows20240913_ea39a1c0-6b12-77ba-e053-2995a90a7314.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
14141-309-01141410309011 TUBE in 1 CARTON (14141-309-01) / 3 g in 1 TUBE1 tube2022-10-070000-00-00NoNoCurrent