Home NDC 69231-033 CLE CCC Neutral Fair
Product NDC 69231-033
11-digit product format 692310033
Labeler code 69231
Product ID 69231-033_29aa6ec9-9b5a-2b6b-e063-6294a90adf28
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Octinoxate, Octisalate
Dosage form CREAM
Route TOPICAL
Labeler KW ABSC, INC.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-10-24
Substance OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE
Active strength 2.1; .9; 2.757 mg/30mL; mg/30mL; mg/30mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base CLE CCC Neutral Fair
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 2.1 mg/30mL OCTISALATE .9 mg/30mL TITANIUM DIOXIDE 2.757 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4Y5P7MUD51 Internal UNII lookup 4X49Y0596W Internal UNII lookup 15FIX9V2JP Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69231-033-01 CLE CCC Neutral Fair 30 mL in 1 CONTAINER CREAM 30 2 69231-033-02 CLE CCC Neutral Fair 1 in 1 PACKAGE CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69231-033 CLE CCC NEUTRAL FAIR (TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) CREAM [KW ABSC, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20241222_aa8176c6-f1c9-43dd-96e0-f7d6ed30a1a2.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69231-033-01 69231003301 30 mL in 1 CONTAINER 30 ml Historical 69231-033-02 69231003302 1 CONTAINER in 1 PACKAGE (69231-033-02) / 30 mL in 1 CONTAINER (69231-033-01) 1 container 2022-10-24 0000-00-00 No No Current