CLE CCC Warm Medium

Product NDC
69231-025
11-digit product format
692310025
Labeler code
69231
Product ID
69231-025_7baea303-1384-5a69-e053-2991aa0a5f54
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Octinoxate, Octisalate
Dosage form
CREAM
Route
TOPICAL
Labeler
KW ABSC, INC.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-11-27
Substance
OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE
Active strength
2.1; .9; 2.52846 mg/30mL; mg/30mL; mg/30mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CLE CCC Warm Medium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE2.1 mg/30mL
OCTISALATE.9 mg/30mL
TITANIUM DIOXIDE2.52846 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Y5P7MUD51, 4X49Y0596W, 15FIX9V2JP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69231-025-01CLE CCC Warm Medium30 mL in 1 CONTAINERCREAM301
69231-025-02CLE CCC Warm Medium1 in 1 PACKAGECREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69231-025CLE CCC WARM MEDIUM (TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) CREAM [KW ABSC, INC.]1Current NDC, Legacy NDC, 2 package rows20181128_b585f216-4234-47c5-9a6b-8b133ef48aae.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69231-025-016923100250130 mL in 1 CONTAINER30 mlHistorical
69231-025-02692310025021 CONTAINER in 1 PACKAGE (69231-025-02) / 30 mL in 1 CONTAINER (69231-025-01) 1 container2018-11-270000-00-00NoNoCurrent