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 284 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Safeway Signature Care Dry Touch Sunscreen SPF 55	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Safeway, Inc.	c6267a29-46a5-5f38-e053-2a95a90a0117	2024-10-14	Warnings	Exact identifier application number: M020
Open Nature Zinc Oxide Sunscreen Mineral Sunscreen SPF 30	ZINC OXIDE	Safeway, Inc.	dbeff8e8-250d-8274-e053-2995a90a984e	2024-10-14	Warnings	Exact identifier application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10N	HOMOSALATE, ZINC OXIDE	Rare Beauty, LLC	2460281d-d433-0216-e063-6394a90a9d48	2024-10-13	Warnings	Exact identifier application number: M020
Walgreens 50 Coconut Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	2436987c-2afe-06b5-e063-6394a90aceba	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens 50 Banana Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	2436bd19-2299-6e89-e063-6394a90acd99	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens SPF 50 Clear Complexion Face Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	f07238df-4970-7759-e053-2a95a90a39f9	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens SPF 70 Sport Continuous	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE	WALGREEN COMPANY	e7165b39-54f9-4af6-e053-2a95a90af664	2024-10-11	Warnings	Exact identifier application number: M020
WALGREENS SPF 100 SHEER BODY SUNSCREEN MIST	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	f14bb3b4-1dce-06b9-e053-2995a90a8bc8	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens SPF 30 Sport	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	f12c9767-7cb7-12c8-e053-2995a90a17be	2024-10-11	Warnings	Exact identifier application number: M020
Sulwhasoo UV Daily Cream	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM	Amorepacific Corporation	e00451d5-8433-c4e8-e053-2a95a90a6244	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens SPF 50 Sport Continuous Sunscreen	AVOBENZONE, HOMOSALAT, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	f13ec3da-2dc2-04f7-e053-2995a90a198d	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens SPF 30 Hydrating	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	f4155692-16a7-11e8-e053-2995a90abd34	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens Daily Facial Moisturizer with Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	f906792b-083e-13e2-e053-6294a90ab4cf	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens Daytime Facial Moisturizer with Broad Spectrum SPF 30 Sunscreen	HOMOSALATE, OCTOCRYLENE, ZINC OXIDE	WALGREEN COMPANY	f9c81d88-8e28-fa53-e053-6394a90ac5c4	2024-10-11	Warnings	Exact identifier application number: M020
WALGREENS 100 SHEER BROAD SPECTRUM SPF 100	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	fa18067a-310b-bdc3-e053-6394a90aee79	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens 50 Mineral Zinc Oxide Sunscreen	ZINC OXIDE	WALGREEN COMPANY	24223fbf-8ce9-ec5e-e063-6294a90a29da	2024-10-10	Warnings	Exact identifier application number: M020
Walgreens 50 Mineral Zinc Oxide Sunscreen	ZINC OXIDE	WALGREEN COMPANY	2422b327-ea83-f4c3-e063-6394a90a5c6e	2024-10-10	Warnings	Exact identifier application number: M020
Walgreens 50 Watermelon Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	24256e54-ae34-91b2-e063-6394a90a33c0	2024-10-10	Warnings	Exact identifier application number: M020
Walgreens 50 Premium Face Moisturizing Sunscreen	AVOBENZONE. HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	24265a48-fd07-c78a-e063-6394a90ab67e	2024-10-10	Warnings	Exact identifier application number: M020
Walgreens Broad Spectrum SPF 50 Body Oil Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	2410df0a-db52-0769-e063-6394a90a52f3	2024-10-09	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