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 307 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EA EIGHT HR LIP SHEER TINTS	OXYBENZONE, PADIMATE O, PETROLATUM	REVLON	b671d630-2b71-66d2-e053-2a95a90a8461	2024-01-12	Warnings	Exact identifier application number: M020
Revlon Colorstay Light Cover Foundation	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE,ZINC OXIDE	Revlon	b0006b5f-0d56-0efb-e053-2a95a90a5979	2024-01-12	Warnings	Exact identifier application number: M020
PREVAGE CITY SMART	TITANIUM DIOXIDE, ZINC OXIDE	REVLON	b60c9b41-cf32-ee94-e053-2a95a90abab0	2024-01-12	Warnings	Exact identifier application number: M020
CERAMIDE MAKEUP SPF 15	OCTINOXATE, TITANIUM DIOXIDE	REVLON	b3ad9686-47ed-4b60-e053-2995a90abcdd	2024-01-12	Warnings	Exact identifier application number: M020
Aruba Aloe broad spectrum SPF 15 Lip sunscreen and Moisturizer	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Aruba Aloe Balm NV	9e3ed6dc-14ba-4bb2-a633-1a1fe92099ce	2024-01-11	Warnings	Exact identifier application number: M020
Principal Secret Reclaim Botanical (with SP) Radiant Recovery Day Broad Spectrum SPF 15	OCTINOXATE, OCTISALATE, AND ZINC OXIDE	Guthy-Renker LLC	6437fbf6-c84b-497e-bf69-b20153d4c706	2024-01-11	Warnings	Exact identifier application number: M020
I Conceal Flawless Foundation BS SPF 30 Sunscreen SUEDE	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	0e9d006c-2ea0-8228-e063-6394a90a65d6	2024-01-10	Warnings	Exact identifier application number: M020
Principal Secret Reclaim Sunscreen For Face and Body SPF 30	MERADIMATE, OCTINOXATE, OXYBENZONE, AND ZINC OXIDE	Guthy-Renker LLC	4a183aa2-deda-4b26-a126-6f98cfbdb0f3	2024-01-10	Warnings	Exact identifier application number: M020
EVEN BETTER MAKEUP BROAD SPECTRUM SPF 15	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	d4de3c7b-3993-40e5-88a4-f6005ab97531	2024-01-09	Warnings	Exact identifier application number: M020
Principal Secret Reclaim Oil Control hydrator SPF-8	TITANIUM DIOXIDE	Guthy-Renker LLC	97b7cd4e-78aa-418b-a112-263971fa9827	2024-01-08	Warnings	Exact identifier application number: M020
Principal Secret Advanced with Hydrospheres Continuous Moisture SPF8	OCTINOXATE AND OCTISALATE	Guthy-Renker LLC	f4310455-8b3f-40a9-8674-fe7fc3abaced	2024-01-08	Warnings	Exact identifier application number: M020
Aruba Sun SPF 30 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6%	Derma Care Research Labs,LLC	d8b4f8c4-811b-4139-e053-2995a90a04c2	2024-01-05	Warnings	Exact identifier application number: M020
MIAMI BEACH BUM Save Face Sheer Mineral Sunscreen SPF 50	ZINC OXIDE	MIAMI BEACH BUM	95675bd2-a0ae-44db-a75a-5c432e961495	2024-01-04	Warnings	Exact identifier application number: M020
GINZING SPF 30 DAILY MOISTURIZER	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	ORIGINS NATURAL RESOURCES INC.	0e106c03-4c25-5bfb-e063-6294a90ab3e1	2024-01-03	Warnings	Exact identifier application number: M020
Avon Anew Platinum Day-Cream SPF 25 Sunscreen	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Avon Company	148203ef-7d73-369c-e063-6394a90a0e58	2024-01-03	Warnings	Exact identifier application number: M020
Avon Anew Ultimate Day Multi-Performance-Cream SPF 25 Sunscreen	AVOBENZONE, HOMOSALATE, OCTINOXATE, OXYBENZONE	The Avon Company	14833e71-704d-9a88-e063-6394a90a31b2	2024-01-03	Warnings	Exact identifier application number: M020
Prime Time Daily Protecting Primer SPF 30	SPF 30 PRIME TIME PRIMER	Autumn Harp Inc.	f2619092-3e7f-5105-e053-2a95a90a3f5a	2024-01-03	Warnings	Exact identifier application number: M020
ARTISTRY IDEAL RADIANCE UV Protect SPF 50 PLUS Broad Spectrum Sunscreen	OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE	Amway Corp	a1a700b5-d039-4bd2-8420-5c2053095706	2024-01-02	Warnings	Exact identifier application number: M020
Garnier green labs Replumping HyaluMelon Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	LOreal USA Products Inc	5bece3c9-c310-4fb2-b644-507407fcfb08	2024-01-02	Warnings	Exact identifier application number: M020
Josie Maran Argan Daily Moisturizer SPF47 Protect and Perfect	ZINC OXIDE, TITANIUM DIOXIDE	Autumn Harp, Inc.	cb91c130-45d4-46a0-9628-50e701a6960c	2024-01-02	Boxed warning, 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