Home NDC 69231-031 CLE CCC Cool Medium Deep
Product NDC 69231-031
11-digit product format 692310031
Labeler code 69231
Product ID 69231-031_29aa6ec9-9b5b-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; 2.535 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 Cool Medium Deep
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 2.1 mg/30mL OCTISALATE .9 mg/30mL TITANIUM DIOXIDE 2.535 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 69231-031-01 CLE CCC Cool Medium Deep 30 mL in 1 CONTAINER CREAM 30 2 69231-031-02 CLE CCC Cool Medium Deep 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 69231-031 CLE CCC COOL MEDIUM DEEP (TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) CREAM [KW ABSC, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20241222_2e0365f9-d3c6-4404-90ac-772a829b3ade.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 132 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Prevention Body ZINC OXIDE NY BEAUTY PALACE LLC 373cef98-a61d-dd36-e063-6394a90a7c3b 2025-12-11 Exact identifier application number: M020 Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly Tinted ZINC OXIDE NY BEAUTY PALACE LLC 373d1e6c-9c32-20f5-e063-6294a90af86f 2025-12-11 Exact identifier application number: M020 Prevention 2 Acne Safe Facial Mineral Sunscreen Non Tinted TITANIUM DIOXIDE, ZINC OXIDE NY BEAUTY PALACE LLC 373c0ab0-8828-542b-e063-6394a90a8633 2025-12-11 Exact identifier application number: M020 Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly Tinted ZINC OXIDE NY BEAUTY PALACE LLC 373ddad0-ed33-a233-e063-6294a90a19cd 2025-12-11 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE SKINPLICITY STUDIO LLC 37263083-b24f-5a71-e063-6294a90aee7d 2025-12-11 Exact identifier application number: M020 Prevention Acne Safe Facial Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE NY BEAUTY PALACE LLC 373d4fad-141c-0904-e063-6394a90a9759 2025-12-11 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE SKINPLICITY STUDIO LLC 37265b3d-92ef-ef4a-e063-6294a90a8d95 2025-12-11 Exact identifier application number: M020 Prevention Body ZINC OXIDE NY BEAUTY PALACE LLC 373d902f-f7b6-298b-e063-6394a90a9307 2025-12-11 Exact identifier application number: M020 Nourish And Defend ZINC OXIDE ANASTASIA FOX-TOMYLOVYCH 3726c177-2912-a6cc-e063-6394a90a0043 2025-12-11 Exact identifier application number: M020 Nourish And Defend ZINC OXIDE ANASTASIA FOX-TOMYLOVYCH 3726f463-7e55-c2a2-e063-6394a90a3c51 2025-12-11 Exact identifier application number: M020 Mattify Total Protection Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 37617bd5-c275-aeee-e063-6394a90a214d 2025-12-11 Exact identifier application number: M020 Not YO 80s Zinc Sunscreen ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 37644dfd-e96d-a783-e063-6294a90a9796 2025-12-11 Exact identifier application number: M020 Not YO 80s Zinc Sunscreen ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 3762f132-4ab0-74ad-e063-6394a90a436c 2025-12-11 Exact identifier application number: M020 GLOW UP Ageless Daily Protection Sunscreen ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 37637e45-c6ed-12ca-e063-6294a90aeb02 2025-12-11 Exact identifier application number: M020 Face and Body Sunscreen ZINC OXIDE SCIENCE CEUTICALS, LLC 369b42f3-5203-87c4-e063-6394a90a6284 2025-12-11 Exact identifier application number: M020 Nourish Non-Tinted Mineral Sunscreen ZINC OXIDE Fern Burg 34a32097-de93-9b1d-e063-6394a90a41df 2025-12-11 Exact identifier application number: M020 Mattify Total Protection Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 37641f8b-0133-8bfc-e063-6294a90aac5c 2025-12-11 Exact identifier application number: M020 GLOW UP Ageless Daily Protection Sunscreen ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 3764856a-98c5-334e-e063-6394a90a629d 2025-12-11 Exact identifier application number: M020 Essential Mineral Sun Protection TITANIUM DIOXIDE, ZINC OXIDE Fern Burg 34a360b2-6798-c7e8-e063-6294a90a5cbb 2025-12-11 Exact identifier application number: M020 Nourish Non-Tinted Mineral Sunscreen ZINC OXIDE Fern Burg 34a3e268-e376-11a0-e063-6294a90a46af 2025-12-11 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 69231-031-01 69231003101 30 mL in 1 CONTAINER 30 ml Historical 69231-031-02 69231003102 1 CONTAINER in 1 PACKAGE (69231-031-02) / 30 mL in 1 CONTAINER (69231-031-01) 1 container 2022-10-24 0000-00-00 No No Current