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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2e0365f9-d3c6-4404-90ac-772a829b3ade	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d676a241-be05-4740-b3ee-1a5f2ed422d2	Product name	4	20180615
dd8bd48f-20d6-43c7-b471-3ae872868afa	Product name	3	20180125
d41954ff-bc63-4b2c-aba0-9146707659d7	Product name	2	20151117

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 254 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BABYGANICS SPF 50 Plus SUNSCREEN	ZINC OXIDE, OCTISALATE, AND OCTOCRYLENE	KAS Direct LLC dba Babyganics	4075f9dc-c25f-434f-a3fc-a7f896295c3d	2024-12-20	Warnings	Exact identifier application number: M020
Sunscreen	HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE	Total Resources International	7d4f820d-e154-428e-89c2-2e26e088ceef	2024-12-20	Warnings	Exact identifier application number: M020
Babyganics Sheer Blend SPF50 Mineral Sunscreen	ZINC OXIDE	KAS Direct LLC dba BabyGanics	edced0dc-dd43-4ac9-b816-f4edb45fc87b	2024-12-20	Warnings	Exact identifier application number: M020
NARS Radiance Primer Broad Spectrum SPF 35 Sunscreen	OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE	COSMAX USA, CORPORATION	29ad7391-d932-3549-e063-6394a90ab2b2	2024-12-20	Warnings	Exact identifier application number: M020
Face Reality daily spf 30 plus Sunscreen SPF 30	HOMOSALATE, OCTISALATE, AVOBENZONE	Face Reality,LLC	45a3ce12-15fe-4040-95da-ac8513a39fb9	2024-12-20	Warnings	Exact identifier application number: M020
Face Reality mineral matte spf 28 Sunscreen SPF 28	ZINC OXIDE, TITANIUM DIOXIDE	Face Reality, LLC	29b70afe-cf9d-d0ba-e063-6394a90a1cc4	2024-12-20	Warnings	Exact identifier application number: M020
Sonage Roux Tinted Day Creme with SPF 30 Sheer Tinted Moisturizer	ZINC OXIDE	ASA Universal Inc. dba: Sonage	fd14d70c-6cd0-5de6-e053-6294a90a7add	2024-12-20	Warnings	Exact identifier application number: M020
Coola SPF 50 Classic	SUNSCREEN FACE MIST	COOLA LLC	d18d0dac-5690-436e-e053-2995a90a0254	2024-12-20	Warnings	Exact identifier application number: M020
COOLA Mineral Body SPF 30 Tropical Coconut	ZINC OXIDE	COOLA, LLC	eeb5d4f1-8cba-9ef6-e053-2a95a90a823f	2024-12-20	Warnings	Exact identifier application number: M020
Oars and Alps SPF 50 100% Mineral Antioxidant Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Oars and Alps LLC	f3971b85-a13e-4195-e053-2995a90a73cb	2024-12-20	Warnings	Exact identifier application number: M020
Vacation SPF 30 Mineral	ZINC OXIDE	Vacation Inc.	f69513ae-f210-075f-e053-2a95a90a9b2e	2024-12-20	Warnings	Exact identifier application number: M020
Vacation SPF 30 Chardonnay Oil	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Vacation Inc.	f694752d-4839-3768-e053-2995a90a5d3e	2024-12-20	Warnings	Exact identifier application number: M020
Oars and Alps SPF 50 Hydrating Antioxidant SunscreenSpray	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Oars and Alps LLC	ec5b82f5-b36c-fbc5-e053-2995a90afa0c	2024-12-20	Warnings	Exact identifier application number: M020
Oars and Alps SPF 70 Hydrating Antioxidant Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Oars and Alps LLC	f39673a7-0b62-bdf7-e053-2995a90aa2b7	2024-12-20	Warnings	Exact identifier application number: M020
Carpe SPF 30 Face Primer	TITANIUM DIOXIDE, ZINC OXIDE	Clutch, Inc. DBA Carpe	feac5ee2-faa5-fd17-e053-6394a90a7f99	2024-12-20	Warnings	Exact identifier application number: M020
Oars and Alps SPF 50 Mineral	ZINC OXIDE	Oars and Alps LLC	f395bc39-daa5-53b8-e053-2995a90a5f48	2024-12-20	Warnings	Exact identifier application number: M020
Babyganics Kids Sheer Blend SPF50 Mineral Sunscreen	ZINC OXIDE	KAS Direct LLC dba BabyGanics	8a143645-3b52-4797-9b26-dc9dd63be38f	2024-12-20	Warnings	Exact identifier application number: M020
Nuria Defend Matte Finish Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Small World Brands	b1df4c81-333b-450d-963e-6670ab9bbda9	2024-12-20	Warnings	Exact identifier application number: M020
foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 8B porcelain beige	TITANIUM DIOXIDE AND ZINC OXIDE	Tarte, Inc.	062fa0d9-f384-48af-8269-42de3a788db1	2024-12-20	Warnings	Exact identifier application number: M020
Stokoderm Sunscreen PURE	AVOBENZONE, OCTOCRYLENE, OCTISALATE, AND HOMOSALATE	SC Johnson Professional USA, Inc.	3ddf81e6-de78-4f2f-814b-c75eadcddb39	2024-12-20	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
69231-031_CLE CCC Cool Medium Deep	KW ABSC, INC. \| Cit Co., Ltd	2024-12-19	HUMAN OTC DRUG LABEL	2