ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR

Product NDC: 10345-911
11-digit product format: 103450911
Labeler code: 10345
Product ID: 10345-911_28fe0211-73d3-ef2b-e063-6294a90a08c1
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: LABORATOIRES M&L
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-07-13
Substance: OCTISALATE; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 20; 60; 43.3; 19.2 mg/mL; mg/mL; mg/mL; mg/mL
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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: ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTISALATE	20 mg/mL
OCTINOXATE	60 mg/mL
TITANIUM DIOXIDE	43.3 mg/mL
ZINC OXIDE	19.2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4X49Y0596W	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
15FIX9V2JP	Internal UNII lookup
SOI2LOH54Z	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
b55be8cb-7f21-45b0-bb8f-a60182077ca3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10345-911-01	ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR	1.5 mL in 1 PACKET	CREAM	1.5		15
10345-911-05	ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR	1 in 1 BOX	CREAM	1		15
10345-911-05	ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR	5 mL in 1 TUBE	CREAM	5		15
10345-911-15	ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR	15 mL in 1 TUBE	CREAM	15		15
10345-911-15	ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR	1 in 1 BOX	CREAM	1		15
10345-911-45	ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR	1 in 1 BOX	CREAM	1		15
10345-911-45	ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR	45 mL in 1 TUBE	CREAM	45		15
10345-911-01	ERBORIAN DOUBLE SAMPLE CC CREME CLAIR and DORE SPF 25	1.5 mL in 1 PACKET	CREAM	1.5 mL	60 mg in 1mL	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10345-911	ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	15	Current NDC, Legacy NDC, 7 package rows	20241213_b55be8cb-7f21-45b0-bb8f-a60182077ca3.zip
10345-911	ERBORIAN DOUBLE SAMPLE CC CREME CLAIR AND DORE SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) KIT [LABORATOIRES M&L]	12	Current NDC, Legacy NDC	20250112_41b3cf18-dc11-4e1d-802e-5ba25bd87adb.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 90 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SHISEIDO ULTIMATE SUN PROTECTOR	OCTISALATE, TITANIUM DIOXIDE, OCTOCRYLENE, AND ZINC OXIDE	SHISEIDO AMERICAS CORPORATION	c656792a-e1ed-478d-b501-9bdc92d16eca	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 110 ALABASTER	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	0a214b6b-69a7-4cb9-9095-6fcf2b6945de	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 430 CEDAR	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	fb6ac681-ff74-4420-a4f6-843d5f2b6d6b	2026-01-05	Warnings	Exact identifier application number: M020
CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE	SHISEIDO AMERICAS CORPORATION	207e2035-5f31-4745-a801-b386b040b738	2026-01-05	Warnings	Exact identifier application number: M020
Hawaiian Blend Essential Zinc SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	The Islander Group	47aa8605-e536-b998-e063-6394a90ad9f0	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM NATURAL LIGHT	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	bf736c5b-fc33-4cd5-8d18-03929f739d76	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E Golden 1	OCTINOXATE	SHISEIDO AMERICAS CORPORATION	8a9294c2-3933-4f9c-b7e6-1f446f441a16	2026-01-05	Warnings	Exact identifier application number: M020
Shiseido Future Solution LX Total Protective	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE	SHISEIDO AMERICAS CORPORATION	6de17911-4bce-46c9-906b-07d899a36ceb	2026-01-05	Warnings	Exact identifier application number: M020
CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES IVORY	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	c4028089-677f-4d51-9c8b-3892ff1649e0	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 110	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	8a0da327-a805-4ef9-b69a-14bf7278a81a	2026-01-05	Warnings	Exact identifier application number: M020
CLE DE PEAU BEAUTE CORRECTING VEIL n	ENSULIZOLE, OCTINOXATE, AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	fd9b42e4-6f9d-45a9-bee3-ac1bc4b35252	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO THE MAKEUP FOUNDATION I20	TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	3c024fe9-2983-4857-a55a-13406158e3a9	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE RADIANT FLUID FOUNDATION BF10	TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	b2b55a7a-1f68-429d-ba70-5bb6c7e0d8d3	2026-01-05	Warnings	Exact identifier application number: M020
HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 BERRY BALMY	ZINC OXIDE	Kao USA Inc.	26bcb9cd-bfb5-998c-e063-6394a90ab9d6	2026-01-05	Warnings	Exact identifier application number: M020
HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 VANILLA CLOUD	ZINC OXIDE	Kao USA Inc.	26cf1320-aae5-2ea0-e063-6394a90a3be2	2026-01-05	Warnings	Exact identifier application number: M020
OZE SUN BONDI	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	47b1aae6-0b86-7d48-e063-6294a90a9ece	2026-01-05	Warnings	Exact identifier application number: M020
Hybrid SPF SPF 30	OCTOCRYLENE, OCTISALATE, ZINC OXIDE	Topiderm, Inc.	5c99f98c-025c-4886-824f-af968033baf4	2026-01-05	Warnings	Exact identifier application number: M020
TRICK AND TREAT CC2 - Active Moisturizing Color Correcting Broad-Spectrum SPF 46 Plus	TITANIUM DIOXIDE	HEY HONEY INC.	21187805-fae9-476c-81b0-27ffeb0b9911	2026-01-05	Warnings	Exact identifier application number: M020
VEAKSON BEEF TALLOW SUNSCREEN	ZINC OXIDE,PHENYLBENZIMIDAZOLE SULFONIC ACID	Guangdong Aimu Biological Technology Co., Ltd	473c241a-1258-1680-e063-6394a90a7d98	2026-01-04	Warnings	Exact identifier application number: M020
HYDRATING SUNSCREEN	HYDRATING SUNSCREEN	Guangzhou Yapeng Refinement Chemical Co., Ltd.	19a3687b-32b0-7c83-e063-6294a90aaf81	2026-01-04	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10345-911-01	10345091101	1.5 mL in 1 PACKET (10345-911-01)	1.5 ml	2017-12-03	0000-00-00	Yes	No	Current
10345-911-05	10345091105	1 TUBE in 1 BOX (10345-911-05) / 5 mL in 1 TUBE	1 tube	2018-07-01	0000-00-00	No	No	Current
10345-911-15	10345091115	1 TUBE in 1 BOX (10345-911-15) / 15 mL in 1 TUBE	1 tube	2016-07-13	0000-00-00	No	No	Current
10345-911-45	10345091145	1 TUBE in 1 BOX (10345-911-45) / 45 mL in 1 TUBE	1 tube	2016-07-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ERBORIAN - DOUBLE SAMPLE CC CREME CLAIR & DORE SPF 25	LABORATOIRES M&L	2025-01-09	HUMAN OTC DRUG LABEL	12
ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR	LABORATOIRES M&L	2024-12-11	HUMAN OTC DRUG LABEL	15