FDA.reportPublic FDA data

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
IngredientStrength
OCTISALATE20 mg/mL
OCTINOXATE60 mg/mL
TITANIUM DIOXIDE43.3 mg/mL
ZINC OXIDE19.2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b55be8cb-7f21-45b0-bb8f-a60182077ca3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10345-911-01ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR1.5 mL in 1 PACKETCREAM1.515
10345-911-05ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR1 in 1 BOXCREAM115
10345-911-05ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR5 mL in 1 TUBECREAM515
10345-911-15ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR15 mL in 1 TUBECREAM1515
10345-911-15ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR1 in 1 BOXCREAM115
10345-911-45ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR1 in 1 BOXCREAM115
10345-911-45ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR45 mL in 1 TUBECREAM4515
10345-911-01ERBORIAN DOUBLE SAMPLE CC CREME CLAIR and DORE SPF 251.5 mL in 1 PACKETCREAM1.5 mL60 mg in 1mL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10345-911ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]15Current NDC, Legacy NDC, 7 package rows20241213_b55be8cb-7f21-45b0-bb8f-a60182077ca3.zip
10345-911ERBORIAN DOUBLE SAMPLE CC CREME CLAIR AND DORE SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) KIT [LABORATOIRES M&L]12Current NDC, Legacy NDC20250112_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 131 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Non Tinted Mineral SunscreenZINC OXIDESPECKTRA6 LLC374f063a-1ea6-2fcc-e063-6394a90ac5742025-12-11Exact identifier
application number: M020
Defend Tinted Mineral SPF 40TITANIUM DIOXIDE, ZINC OXIDESMOOTH ESTHETICS LLC36eb9fc0-25d7-cfb4-e063-6394a90a2e222025-12-11Exact identifier
application number: M020
Sheer Tinted Sunscreen SPF40TITANIUM DIOXIDE, ZINC OXIDESIMPLICITY SKIN, SPA & BOUTIQUE, LLC36ebdb85-ce8a-d7e0-e063-6394a90a22612025-12-11Exact identifier
application number: M020
Solar Shield Face and Body SPF 40ZINC OXIDEBRIGHT SKINCARE, LLC3b138432-19e5-e757-e063-6294a90a4cbe2025-12-11WarningsExact identifier
application number: M020
Solar Shield Primer SPF 40ZINC OXIDEBRIGHT SKINCARE, LLC3b149758-bbe1-bd66-e063-6294a90afe782025-12-11WarningsExact identifier
application number: M020
Solar Shield Face and Body SPF 40ZINC OXIDEBRIGHT SKINCARE, LLC3b14caa3-f58e-b9ab-e063-6394a90a96952025-12-11WarningsExact identifier
application number: M020
Solar Shield Primer SPF 40ZINC OXIDEBRIGHT SKINCARE, LLC3b152e27-3917-eb7e-e063-6394a90a1f432025-12-11WarningsExact identifier
application number: M020
Mineral Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDECOLETTE TOMASI LLC3727b29f-fe51-0b15-e063-6394a90a780b2025-12-11Exact identifier
application number: M020
Daytime Moisture SPF40ZINC OXIDECOLETTE TOMASI LLC372773b6-fc37-c74b-e063-6294a90a7bf22025-12-11Exact identifier
application number: M020
Prevention Acne Safe Facial Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373c291a-7839-8486-e063-6294a90a5af32025-12-11Exact identifier
application number: M020
Prevention BodyZINC OXIDENY BEAUTY PALACE LLC373cef98-a61d-dd36-e063-6394a90a7c3b2025-12-11Exact identifier
application number: M020
Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly TintedZINC OXIDENY BEAUTY PALACE LLC373d1e6c-9c32-20f5-e063-6294a90af86f2025-12-11Exact identifier
application number: M020
Prevention 2 Acne Safe Facial Mineral Sunscreen Non TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373c0ab0-8828-542b-e063-6394a90a86332025-12-11Exact identifier
application number: M020
Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly TintedZINC OXIDENY BEAUTY PALACE LLC373ddad0-ed33-a233-e063-6294a90a19cd2025-12-11Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDESKINPLICITY STUDIO LLC37263083-b24f-5a71-e063-6294a90aee7d2025-12-11Exact identifier
application number: M020
Prevention Acne Safe Facial Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373d4fad-141c-0904-e063-6394a90a97592025-12-11Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDESKINPLICITY STUDIO LLC37265b3d-92ef-ef4a-e063-6294a90a8d952025-12-11Exact identifier
application number: M020
Prevention BodyZINC OXIDENY BEAUTY PALACE LLC373d902f-f7b6-298b-e063-6394a90a93072025-12-11Exact identifier
application number: M020
Nourish And DefendZINC OXIDEANASTASIA FOX-TOMYLOVYCH3726c177-2912-a6cc-e063-6394a90a00432025-12-11Exact identifier
application number: M020
Nourish And DefendZINC OXIDEANASTASIA FOX-TOMYLOVYCH3726f463-7e55-c2a2-e063-6394a90a3c512025-12-11Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10345-911-01103450911011.5 mL in 1 PACKET (10345-911-01) 1.5 ml2017-12-030000-00-00YesNoCurrent
10345-911-05103450911051 TUBE in 1 BOX (10345-911-05) / 5 mL in 1 TUBE1 tube2018-07-010000-00-00NoNoCurrent
10345-911-15103450911151 TUBE in 1 BOX (10345-911-15) / 15 mL in 1 TUBE1 tube2016-07-130000-00-00NoNoCurrent
10345-911-45103450911451 TUBE in 1 BOX (10345-911-45) / 45 mL in 1 TUBE1 tube2016-07-130000-00-00NoNoCurrent