ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMEL

Product NDC: 10345-913
11-digit product format: 103450913
Labeler code: 10345
Product ID: 10345-913_28fdfd84-8898-2162-e063-6294a90a075b
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: 2018-08-21
Substance: OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 60; 20; 88.4; 38.4 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 CARAMEL
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTINOXATE	60 mg/mL
OCTISALATE	20 mg/mL
TITANIUM DIOXIDE	88.4 mg/mL
ZINC OXIDE	38.4 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4Y5P7MUD51	Internal UNII lookup
4X49Y0596W	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
70a5537c-a364-4dae-8ab2-8ca0cbfd11b7	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	SPL version
10345-913-05	ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMEL	1 in 1 BOX	CREAM	1	7
10345-913-05	ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMEL	5 mL in 1 TUBE	CREAM	5	7
10345-913-45	ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMEL	1 in 1 BOX	CREAM	1	7
10345-913-45	ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMEL	45 mL in 1 TUBE	CREAM	45	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10345-913	ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMEL (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]	7	Current NDC, Legacy NDC, 4 package rows	20241213_70a5537c-a364-4dae-8ab2-8ca0cbfd11b7.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 211 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mineral KidStick SPF 40 Mineral Broad Spectrum SPF 40 Sunscreen UVA-UVB Suncreen	TITANIUM DIOXIDE AND ZINC OXIDE	MDSolarSciences	4c7f0257-fa12-40d6-9516-824b0e3a182c	2025-06-05	Warnings	Exact identifier application number: M020
Mineral KidCreme SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	MDSolarSciences	9ec56c68-6fea-444b-aeed-0b5d60c42e75	2025-06-05	Warnings	Exact identifier application number: M020
Kidspray Broad Spectrum Sunscreen SPF 40	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	MDSolarSciences	36df811b-35d2-261d-e063-6394a90aa91e	2025-06-05	Warnings	Exact identifier application number: M020
5-IN-1 TINTED FACE SUNSCREEN - FAIR	ZINC OXIDE	Synchronicity Spa, Inc. DBA Suntegrity	c0892856-cd12-4c1f-8420-866dbd0f8907	2025-06-04	Warnings	Exact identifier application number: M020
Aveeno Calm Plus Restore Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	fbf8be03-93e2-4d7e-e053-6294a90a4fd5	2025-06-04	Warnings	Exact identifier application number: M020
EltaMD UV Clear SPF46	ZINC OXIDE AND OCTINOXATE SUNSCREEN	CP Skin Health Group, Inc.	60438ec5-0b1f-45fd-8ce4-debfdbdc6721	2025-06-04	Warnings	Exact identifier application number: M020
LikePro Skincare Sport Day UV Face Sunscreen SPF 50	OCTOCRYLENE, ZINC OXIDE	LIKE PRO OPTIMAL SKINCARE LLC	b00d0efe-bf22-43a6-ba24-3d5b6ee9c5e1	2025-06-03	Warnings	Exact identifier application number: M020
LikePro Skincare Sport Day UV Face and Body Sunscreen SPF 50	ZINC OXIDE	LIKE PRO OPTIMAL SKINCARE LLC	2ea86aa8-2f28-40bb-9318-fec188f66010	2025-06-03	Warnings	Exact identifier application number: M020
LikePro Skincare Sport Day UV Face and Body Sunscreen SPF 50	ZINC OXIDE	LIKE PRO OPTIMAL SKINCARE LLC	b59a3b67-0e44-426d-9379-0ca31628937a	2025-06-03	Warnings	Exact identifier application number: M020
EthoSun EthoSport Stick Broad Spectrum SPF 40	ZINC OXIDE	EthoSun, Inc	35372859-8f40-5eb0-e063-6294a90a6a00	2025-06-03	Warnings	Exact identifier application number: M020
EthoSun Daily Mineral Sunscreen Broad Spectrum SPF 45	ZINC OXIDE	EthoSun, Inc	d7d2bca6-5000-4cb9-b004-b1ae286f6035	2025-06-03	Warnings	Exact identifier application number: M020
Age Defense for Eyes 5 in 1	ZINC OXIDE AND TITANIUM DIOXIDE	Topiderm, Inc.	48d5343a-1068-4c64-a275-c180026d6947	2025-06-03	Warnings	Exact identifier application number: M020
Ola Botanicals Sunscreen SPF 30	ZINC OXIDE	Natural Health Partners, LLC	c7a7df0b-da8f-407d-a1ee-28f75070b23c	2025-06-02	Warnings	Exact identifier application number: M020
MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50	ZINC OXIDE	Expanscience Laboratories d/b/a Mustela	95ea5442-a7ca-0c7d-e053-2a95a90ad247	2025-06-02	Warnings	Exact identifier application number: M020
Bluevado Sunfix	ZINC OXIDE, TITANIUM DIOXIDE	Magic Blue, LLC	31f1e961-3719-f70a-e063-6394a90a481e	2025-05-31	Warnings	Exact identifier application number: M020
Sunny Sailor First Mate Face Stick SPF 30	ZINC OXIDE	SUNNY SAILOR LLC	8ef7e0c8-e76b-4e84-ac9d-169f85e5e36e	2025-05-28	Warnings	Exact identifier application number: M020
Dr Mercola Broad Spectrum SPF15	ZINC OXIDE	Natural Health Partners, LLC	47f6b19e-ede8-0daf-e054-00144ff88e88	2025-05-28	Warnings	Exact identifier application number: M020
Dr. Mercola Broad Spectrum	ZINC OXIDE	Natural Health Partners, LLC	47f6ec0a-1144-55dd-e054-00144ff8d46c	2025-05-28	Warnings	Exact identifier application number: M020
Dr. Mercola Broad Spectrum	TITANIUM DIOXIDE, ZINC OXIDE	Natural Health Partners, LLC	47f6ab9e-fa73-496a-e054-00144ff8d46c	2025-05-28	Warnings	Exact identifier application number: M020
Celavive Protective Day SPF 30	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE	USANA Health Sciences, Inc.	cf00763f-6b3e-4d50-b639-9a6d6f595961	2025-05-28	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
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
10345-913-05	10345091305	1 TUBE in 1 BOX (10345-913-05) / 5 mL in 1 TUBE	1 tube	2021-04-16	0000-00-00	No	No	Current
10345-913-45	10345091345	1 TUBE in 1 BOX (10345-913-45) / 45 mL in 1 TUBE	1 tube	2018-08-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ERBORIAN - CC CREME HIGH DEFINITION SPF 25 CARAMEL	LABORATOIRES M&L	2024-12-11	HUMAN OTC DRUG LABEL	7