Home NDC 69231-034 CLE CCC Golden Medium
Product NDC 69231-034
11-digit product format 692310034
Labeler code 69231
Product ID 69231-034_29aa4543-0fcc-c9f5-e063-6294a90a3acc
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 2022-10-25
Substance OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE
Active strength 2.1; .9; 2.751 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 Golden Medium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 2.1 mg/30mL OCTISALATE .9 mg/30mL TITANIUM DIOXIDE 2.751 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 69231-034-01 CLE CCC Golden Medium 30 mL in 1 CONTAINER CREAM 30 2 69231-034-02 CLE CCC Golden Medium 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 69231-034 CLE CCC GOLDEN MEDIUM (TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) CREAM [KW ABSC, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20241222_de50e956-a014-4147-922b-63c95fa6f86b.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 128 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Daily Mineral Protection ZINC OXIDE Charisma Skin 352dc69b-86d0-aa15-e063-6294a90a5e4c 2025-12-12 Exact identifier application number: M020 Ultra Sheer Sunscreen ZINC OXIDE SKINBAR MD LLC 35810a90-e2ca-b80b-e063-6294a90a14f0 2025-12-12 Exact identifier application number: M020 Tinted Facial Mineral Sunscreen SPF 40 TITANIUM DIOXIDE, ZINC OXIDE RSL89 LLC 3531d609-a0d8-cb59-e063-6394a90a4bea 2025-12-12 Exact identifier application number: M020 Non-Tinted Zinc Body And Face SPF40 ZINC OXIDE RSL89 LLC 3532102c-8ded-1e78-e063-6294a90ae224 2025-12-12 Exact identifier application number: M020 Non-Tinted Zinc Body And Face SPF40 ZINC OXIDE RSL89 LLC 35330a82-dc6b-49af-e063-6394a90af9ea 2025-12-12 Exact identifier application number: M020 Tinted Replenishing SPF40 ZINC OXIDE RSL89 LLC 353257db-6c30-4a03-e063-6294a90ae45d 2025-12-12 Exact identifier application number: M020 Tinted Facial Mineral Sunscreen SPF 40 TITANIUM DIOXIDE, ZINC OXIDE RSL89 LLC 3532a6a2-dbb5-8111-e063-6294a90aeaeb 2025-12-12 Exact identifier application number: M020 Tinted Replenishing SPF40 ZINC OXIDE RSL89 LLC 35334c75-b3fd-37fa-e063-6294a90ab3b0 2025-12-12 Exact identifier application number: M020 Age Defying Sunscreen ZINC OXIDE GINAMARIE Products 35835565-f10b-e8e7-e063-6394a90ab2d3 2025-12-12 Exact identifier application number: M020 Tinted Daily Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE RSL89 LLC 35338026-525a-d8b3-e063-6394a90a98f5 2025-12-12 Exact identifier application number: M020 Mineral Lip Protection TITANIUM DIOXIDE, ZINC OXIDE RSL89 LLC 3541971e-3664-a9f5-e063-6294a90ac2d2 2025-12-12 Exact identifier application number: M020 Age Defying Sunscreen ZINC OXIDE GINAMARIE Products 35837cf7-91e5-f9ec-e063-6394a90aa91e 2025-12-12 Exact identifier application number: M020 Mineral Sunscreen Face plus Body ZINC OXIDE KS Esthetics, LLC 390a4d8d-b47f-0d9a-e063-6394a90a9b53 2025-12-12 Exact identifier application number: M020 Mineral Sunscreen Tinted Zinc Oxide ZINC OXIDE KS Esthetics, LLC 3909e657-97a5-dd3c-e063-6394a90a10eb 2025-12-12 Exact identifier application number: M020 Prime Protection Sunscreen non tinted TITANIUM DIOXIDE, ZINC OXIDE KRISTI REDD ESTHETICS 36608832-22d8-bc76-e063-6394a90abac6 2025-12-12 Exact identifier application number: M020 Prime Protection Sunscreen, tinted TITANIUM DIOXIDE, ZINC OXIDE KRISTI REDD ESTHETICS 3660af9e-d60f-c33e-e063-6394a90a3a05 2025-12-12 Exact identifier application number: M020 Hydrating Antioxidant Sunscreen tinted ZINC OXIDE KRISTI REDD ESTHETICS 366149e2-b03c-e798-e063-6394a90a6a1d 2025-12-12 Exact identifier application number: M020 Prime Protection Sunscreen, tinted TITANIUM DIOXIDE, ZINC OXIDE KRISTI REDD ESTHETICS 3660e701-1373-eef4-e063-6394a90a6140 2025-12-12 Exact identifier application number: M020 Hydrating Antioxidant Sunscreen tinted ZINC OXIDE KRISTI REDD ESTHETICS 3661251d-b907-8df6-e063-6294a90a1c73 2025-12-12 Exact identifier application number: M020 sheer tinted sunscreen TITANIUM DIOXIDE, ZINC OXIDE SARA ELIZABETH SKINCARE 3b177c49-ed8c-42b9-e063-6294a90a82c6 2025-12-12 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69231-034-01 69231003401 30 mL in 1 CONTAINER 30 ml Historical 69231-034-02 69231003402 1 CONTAINER in 1 PACKAGE (69231-034-02) / 30 mL in 1 CONTAINER (69231-034-01) 1 container 2022-10-25 0000-00-00 No No Current