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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
de50e956-a014-4147-922b-63c95fa6f86b	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
69231-034-01	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 258 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Everyday Coverage Tinted Sunscreen - Extra Light Tint	ZINC OXIDE	MV Advanced	7834c649-5f6d-b005-e053-2a91aa0a1084	2024-12-12	Warnings	Exact identifier application number: M020
Everyday Coverage Tinted Sunscreen - Light Tint	ZINC OXIDE	MV Advanced	783649af-d746-84a3-e053-2991aa0a9e3d	2024-12-12	Warnings	Exact identifier application number: M020
Everyday Coverage Tinted Sunscreen - Medium Tint	ZINC OXIDE	MV Advanced	783649af-d768-84a3-e053-2991aa0a9e3d	2024-12-12	Warnings	Exact identifier application number: M020
Babo SPF 30 Clear Zinc Fragrance Free Sport	MINERAL SUNSCREEN	Babo Botanicals, Inc.	b1a9f76d-0cef-29da-e053-2995a90af34c	2024-12-12	Warnings	Exact identifier application number: M020
Babo Baby Face Mineral Sunscreen	MINERAL SUNSCREEN	Babo Botanicals, Inc.	b131664d-1ad2-0a2f-e053-2995a90acbda	2024-12-12	Warnings	Exact identifier application number: M020
Babo SPF 30 Clear Zinc Fragrance Free	MINERAL SUNSCREEN	Babo Botanicals, Inc.	b3e40cb0-dbfd-955c-e053-2995a90af848	2024-12-12	Warnings	Exact identifier application number: M020
DOCTOR BABOR SOLAR DEFENSE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30	ZINC OXIDE	BABOR Cosmetics America Corp	291ec801-ee15-06a4-e063-6294a90ab32b	2024-12-12	Warnings	Exact identifier application number: M020
All Calm Clinical Redness Corrector SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	68b95e94-3686-4d11-9952-ec86394376ee	2024-12-12	Warnings	Exact identifier application number: M020
Method Men Face with Zinc Oxide Sunscreen	ZINC OXIDE	Method Products Inc.	cce5f8e1-cf40-4524-af2b-1d49309e2809	2024-12-12	Warnings	Exact identifier application number: M020
Sunforgettable Tint du Soleil Foundation SPF 30 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	219e2ef4-e977-4527-8999-14b27d5a7a33	2024-12-12	Warnings	Exact identifier application number: M020
Absolutely Natural Broad Spectrum SPF 50Plus Sunscreen	ZINC OXIDE	Absolutely Natural	4855c2c7-1516-4857-b103-2eb72a60d5d0	2024-12-11	Warnings	Exact identifier application number: M020
Absolutely Natural Broad Spectrum SPF 30 Sunscreen	ZINC OXIDE	Absolutely Natural	b6e8f361-fd31-4f21-9095-c5159a826175	2024-12-11	Warnings	Exact identifier application number: M020
Walgreens Scar Cream w/SPF 30	AVOBENZONE3%,OCTOCRYLENE10%,OXYBENONE 6%	Walgreens	cc72c8c5-f3e9-e8e0-e053-2a95a90ae0b0	2024-12-11	Warnings	Exact identifier application number: M020
ERBORIAN - BB CREME AU GINSENG CLAIR SPF 20	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	ee9ae84b-c8fc-4a87-8910-46ec8ccfe1a9	2024-12-11	Warnings	Exact identifier application number: M020
ERBORIAN - BB CREME AU GINSENG DORE SPF 20	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	121aa873-5ca6-426b-8ece-dcb5a9f82a03	2024-12-11	Warnings	Exact identifier application number: M020
ERBORIAN - CC CREME HIGH DEFINITION SPF 25	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	3421b9a3-6551-406f-af3a-b3da8a01d2b2	2024-12-11	Warnings	Exact identifier application number: M020
ERBORIAN CC RED CORRECT SPF 25	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	Laboratoires M&L	21530925-03b7-40bb-9836-6ee4011c4a79	2024-12-11	Warnings	Exact identifier application number: M020
ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMEL	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	70a5537c-a364-4dae-8ab2-8ca0cbfd11b7	2024-12-11	Warnings	Exact identifier application number: M020
ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	b55be8cb-7f21-45b0-bb8f-a60182077ca3	2024-12-11	Warnings	Exact identifier application number: M020
I Conceal Flawless Foundation Broad Spectrum SPF 30 Sunscreen Deep Honey	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	dc792777-d8b6-3ebc-e053-2a95a90abc3f	2024-12-11	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
69231-034-01	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