ERBORIAN - CC CREME HIGH DEFINITION SPF 25

Product NDC: 10345-910
11-digit product format: 103450910
Labeler code: 10345
Product ID: 10345-910_28fded45-12c4-eea8-e063-6294a90a17ca
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: 2015-02-06
Substance: OCTISALATE; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 20; 60; 49.7; 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 SPF 25
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTISALATE	20 mg/mL
OCTINOXATE	60 mg/mL
TITANIUM DIOXIDE	49.7 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
3421b9a3-6551-406f-af3a-b3da8a01d2b2	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
10345-910-01	ERBORIAN - CC CREME HIGH DEFINITION SPF 25	1.5 mL in 1 PACKET	CREAM	1.5		13
10345-910-05	ERBORIAN - CC CREME HIGH DEFINITION SPF 25	5 mL in 1 TUBE	CREAM	5		13
10345-910-05	ERBORIAN - CC CREME HIGH DEFINITION SPF 25	1 in 1 BOX	CREAM	1		13
10345-910-15	ERBORIAN - CC CREME HIGH DEFINITION SPF 25	1 in 1 BOX	CREAM	1		13
10345-910-15	ERBORIAN - CC CREME HIGH DEFINITION SPF 25	15 mL in 1 TUBE	CREAM	15		13
10345-910-45	ERBORIAN - CC CREME HIGH DEFINITION SPF 25	1 in 1 BOX	CREAM	1		13
10345-910-45	ERBORIAN - CC CREME HIGH DEFINITION SPF 25	45 mL in 1 TUBE	CREAM	45		13
10345-910-01	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 Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
.ALPHA.-HEXYLCINNAMALDEHYDE	INACTIVE INGREDIENT	7X6O37OK2I	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
.BETA.-CITRONELLOL, (R)-	INACTIVE INGREDIENT	P01OUT964K	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
ALUMINUM HYDROXIDE	INACTIVE INGREDIENT	5QB0T2IUN0	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
CENTELLA ASIATICA	INACTIVE INGREDIENT	7M867G6T1U	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
DIPROPYLENE GLYCOL	INACTIVE INGREDIENT	E107L85C40	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
DISTEARDIMONIUM HECTORITE	INACTIVE INGREDIENT	X687XDK09L	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
EUGENOL	INACTIVE INGREDIENT	3T8H1794QW	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
GERANIOL	INACTIVE INGREDIENT	L837108USY	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
HONEY	INACTIVE INGREDIENT	Y9H1V576FH	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
ISOMETHYL-.ALPHA.-IONONE	INACTIVE INGREDIENT	9XP4LC555B	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
LINALOOL, (+/-)-	INACTIVE INGREDIENT	D81QY6I88E	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
MAGNESIUM SULFATE	INACTIVE INGREDIENT	DE08037SAB	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
METHYL TRIMETHICONE	INACTIVE INGREDIENT	S73ZQI0GXM	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
MICA	INACTIVE INGREDIENT	V8A1AW0880	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
PALMITIC ACID	INACTIVE INGREDIENT	2V16EO95H1	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
SILICA DIMETHYL SILYLATE	INACTIVE INGREDIENT	EU2PSP0G0W	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
TRIHYDROXYSTEARIN	INACTIVE INGREDIENT	06YD7896S3	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10345-910	ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	13	Current NDC, Legacy NDC, 7 package rows	20241213_3421b9a3-6551-406f-af3a-b3da8a01d2b2.zip
10345-910	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 259 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mentholatum Medicated Lip Balm Original	DIMETHICONE, OCTINOXATE, OCTISALATE	The Mentholatum Company	f84cc3a4-cc9f-4a38-8b7d-cf8d6cd39df1	2024-12-17	Warnings	Exact identifier application number: M020
Mentholatum Natural Ice Sport SPF 30	AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATE	The Mentholatum Company	57c35631-42d3-4c6c-bcbb-e2de92b45b13	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay TimeWise Repair Volu-Firm Day Cream Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Mary Kay Inc.	5f09503e-c455-4ac2-8d07-e8e66c2daa32	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Light to Medium	HOMOSALATE, OCTINOXATE, OXYBENZONE	Mary Kay Inc.	b5ca4bed-4f89-4020-a055-9d11f4cd5058	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Deep	HOMOSALATE, OCTINOXATE, OXYBENZONE	Mary Kay Inc.	e5fffd20-1d22-485a-9311-4cb4f9264f6f	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very Deep	HOMOSALATE, OCTINOXATE, OXYBENZONE	Mary Kay Inc.	404990e4-9499-4186-b39d-afc31834d334	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Medium to Deep	HOMOSALATE, OCTINOXATE, OXYBENZONE	Mary Kay Inc.	6028e210-a8a3-4d84-a462-16a414c31052	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very Light	HOMOSALATE, OCTINOXATE, OXYBENZONE	Mary Kay Inc.	af22b3a5-ac72-4c2a-aa7e-6b5ca07d89e8	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay TimeWise Daytime Defender Sunscreen Broad Spectrum SPF 30	AVOBENZONE/OCTISALATE/OCTOCRYLENE	Mary Kay Inc.	00f0f30d-236a-fd45-e063-6294a90a747d	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Cherry Cordial, Maple Butter, Frosted Berry	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	bab8447b-58b8-4160-a91e-05f9fd09ed1d	2024-12-17	Warnings	Exact identifier application number: M020
STUDIO FIX FLUID BROAD SPECTRUM SPF 15	OCTINOXATE, TITANIUM DIOXIDE	MAKEUP ART COSMETICS	fb59afc1-1dc9-f783-e053-6394a90a196b	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay Mineral Facial Sunscreen Broad Spectrum SPF30	ZINC OXIDE	Mary Kay Inc.	0e9b15e4-e59c-f266-e063-6394a90ab81c	2024-12-17	Warnings	Exact identifier application number: M020
MAC STUDIO WATERWEIGHT SPF 30 BROAD SPECTRUM FOUNDATION SUNSCREEN	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	MAKEUP ART COSMETICS	e5fd3e40-de1d-4cdd-b725-4a517514ca35	2024-12-17	Warnings	Exact identifier application number: M020
STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35	OCTINOXATE AND TITANIUM DIOXIDE	MAKEUP ART COSMETICS	2d034810-7210-4ad4-be23-ec2100f8c2f1	2024-12-17	Warnings	Exact identifier application number: M020
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Aruba Aloe Balm NV	acda1640-0d35-43dc-8734-d47b00cc85ed	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay Foundation Primer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Mary Kay Inc.	59d25b44-1adb-4790-8ce6-2d847a06b8b3	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay TimeWise Repair Volu-Firm The Go Set	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Mary Kay Inc.	cf7fb8f0-483d-443b-b381-086a255f0783	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay TimeWise Repair Volu-Firm Sampler Set	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Mary Kay Inc.	0a9ee359-19c1-4266-8a51-a68f655de151	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay TimeWise Repair Volu-Firm Set	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Mary Kay Inc.	d459e2f7-dc78-4519-9733-01495fc447a2	2024-12-17	Warnings	Exact identifier application number: M020
Babo Botanicals Daily Sheer Tinted Mineral Sunscreen SPF 50	ZINC OXIDE	Babo Botanicals, Inc.	2982ce67-f136-b93b-e063-6394a90a81ac	2024-12-17	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
10345-910-01	10345091001	1.5 mL in 1 PACKET (10345-910-01)	1.5 ml	2017-12-03	0000-00-00	Yes	No	Current
10345-910-05	10345091005	1 TUBE in 1 BOX (10345-910-05) / 5 mL in 1 TUBE	1 tube	2018-07-01	0000-00-00	No	No	Current
10345-910-15	10345091015	1 TUBE in 1 BOX (10345-910-15) / 15 mL in 1 TUBE	1 tube	2015-02-06	0000-00-00	No	No	Current
10345-910-45	10345091045	1 TUBE in 1 BOX (10345-910-45) / 45 mL in 1 TUBE	1 tube	2015-02-06	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 SPF 25	LABORATOIRES M&L	2024-12-11	HUMAN OTC DRUG LABEL	13