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 19 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Not there spf broad spectrum spf40 moisturizer	AVOBENZONE 3% ,HOMOSALATE 10% ,OCTISALATE 5% ,OCTOCRYLENE 8% ,ZINC OXIDE 4%	Foshan Sugar Max Cosmetics CO.,Ltd	546f0474-4102-26d0-e063-6394a90a388b	2026-06-17	Warnings	Exact identifier application number: M020
Ultra Violette Velvet Screen Blurring Mineral Skinscreen Broad Spectrum SPF 40	ZINC OXIDE	Grace and Fire USA Inc.	52d4b1c1-7431-4f8c-e063-6294a90ad482	2026-06-17	Warnings	Exact identifier application number: M020
EVIL GOODS TALLOW SUNSCREEN SPF30	ZINC OXIDE	Moes Group LLC	54751f23-5723-0407-e063-6294a90a4a96	2026-06-17	Warnings	Exact identifier application number: M020
Amber Sunglaze Sheer Body Mist Sunscreen SPF30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Koco Life LLC	5478fb36-e972-f824-e063-6294a90a567f	2026-06-17	Warnings	Exact identifier application number: M020
Elaine Sterling Hydrating Sunscreen	ZINC OXIDE	Elaine Sterling Enterprises	5479e862-aca5-7541-e063-6394a90ad0c5	2026-06-17	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	BCM Cosmetique SAS	545aa56a-ed07-acd6-e063-6394a90ae0c7	2026-06-16	Warnings	Exact identifier application number: M020
MAYBELLINE NEW YORK FIT ME DEWY PLUS SMOOTH FOUNDATION SPF 18 SUNSCREEN	OCTISALATE	LOreal USA Products Inc	3b99ab06-ba4c-4ddd-a057-60028eedd67d	2026-06-16	Warnings	Exact identifier application number: M020
TERRA LOTUS SPF 50 ORGANIC TALLOW SUNSCREEN	ZINCOXIDE	Moes Group LLC	54617bf2-1d8d-531e-e063-6294a90a7080	2026-06-16	Warnings	Exact identifier application number: M020
Daily Defence Mineral Sunscreen SPF 50 Fragrance Free	ZINC OXIDE	Ultraceuticals Pty Ltd	5461ee82-0297-ce22-e063-6294a90a729b	2026-06-16	Warnings	Exact identifier application number: M020
GlowBiotics Tinted Sunscreen SPF 30	ZINC OXIDE	Rum Brands, LLC	544dba29-4785-4ab6-e063-6394a90a17b3	2026-06-16	Warnings	Exact identifier application number: M020
Societe Prime and Defend	ZINC OXIDE SUNSCREEN	Societe Clinical Skincare	5439bd31-5ee1-9bca-e063-6394a90a748c	2026-06-16	Warnings	Exact identifier application number: M020
Societe CoverShield Tinted SPF	ZINC OXIDE	Societe Clinical Skincare	545efbc4-82d4-f126-e063-6294a90a9710	2026-06-16	Warnings	Exact identifier application number: M020
TITAN TALLOW SPF 50 ORGANIC TALLOW SUNSCREEN	ZINC OXIDE	Moes Group LLC	546b0702-a3cc-fd6f-e063-6394a90af849	2026-06-16	Warnings	Exact identifier application number: M020
365 WHOLE FOODS MARKET MINERAL SPF 30	ZINC OXIDE	Whole Foods Market, Inc.	5ce712d6-cafd-4a80-9f8c-2149fdebff54	2026-06-16	Warnings	Exact identifier application number: M020
365 WHOLE FOODS MARKET MINERAL SPF 50	ZINC OXIDE	Whole Foods Market, Inc.	1f8387be-d871-435b-baef-e537c67a510a	2026-06-15	Warnings	Exact identifier application number: M020
365 WHOLE FOODS MARKET SUNSCREEN CLEAR COCONUT VANILLA SPF 50	OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND HOMOSALATE	Whole Foods Market, Inc.	82771f22-0197-40ba-97d2-2386152790ed	2026-06-15	Warnings	Exact identifier application number: M020
365 WHOLE FOODS MARKET SUNSCREEN CLEAR COCONUT VANILLA SPF 30	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Whole Foods Market, Inc.	1c31f466-6a0d-46ce-9346-d2a0eb46c8d0	2026-06-15	Warnings	Exact identifier application number: M020
Shield by HEALTHY SKIN LAB MD SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	HEALTHY SKIN LAB LIMITED	6838b754-9915-48ff-af35-5338dbd06ac4	2026-06-15	Warnings	Exact identifier application number: M020
Solvyn Mineral Sunscreen SPF 50	ZINC OXIDE	Solvyn Skin LLC	b0a8d028-87d2-4339-8879-c62cbf8415f2	2026-06-15	Warnings	Exact identifier application number: M020
Amrit Ocean Resort Mineral Sunscreen SPF 50	ZINC OXIDE	Solvyn Skin, LLC	112364cd-a445-46c2-b2f3-f9705d682cf6	2026-06-15	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