CLE CCC Golden Medium Deep

Product NDC: 69231-027
11-digit product format: 692310027
Labeler code: 69231
Product ID: 69231-027_7c2408f5-6ee1-3d9c-e053-2a91aa0a1bae
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: 2018-12-03
Substance: OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE
Active strength: 2.1; .9; 2.51454 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 Deep
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTINOXATE	2.1 mg/30mL
OCTISALATE	.9 mg/30mL
TITANIUM DIOXIDE	2.51454 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
b7a4847f-b84d-4f36-8787-104eccd838a0	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
69231-027-01	CLE CCC Golden Medium Deep	30 mL in 1 CONTAINER	CREAM	30		1
69231-027-02	CLE CCC Golden Medium Deep	1 in 1 PACKAGE	CREAM	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69231-027	CLE CCC GOLDEN MEDIUM DEEP (TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE) CREAM [KW ABSC, INC.]	1	Current NDC, Legacy NDC, 2 package rows	20181204_b7a4847f-b84d-4f36-8787-104eccd838a0.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLE CCC Golden Medium Deep	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	b7a4847f-b84d-4f36-8787-104eccd838a0	2018-12-03	Warnings	Exact identifier ndc (product): 69231-027

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
69231-027-01	69231002701	30 mL in 1 CONTAINER	30 ml					Historical
69231-027-02	69231002702	1 CONTAINER in 1 PACKAGE (69231-027-02) / 30 mL in 1 CONTAINER (69231-027-01)	1 container	2018-12-03	0000-00-00	No	No	Current