FDA.reportPublic FDA data

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
IngredientStrength
OCTISALATE20 mg/mL
OCTINOXATE60 mg/mL
TITANIUM DIOXIDE49.7 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
3421b9a3-6551-406f-af3a-b3da8a01d2b2Available 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
10345-910-01ERBORIAN - CC CREME HIGH DEFINITION SPF 251.5 mL in 1 PACKETCREAM1.513
10345-910-05ERBORIAN - CC CREME HIGH DEFINITION SPF 255 mL in 1 TUBECREAM513
10345-910-05ERBORIAN - CC CREME HIGH DEFINITION SPF 251 in 1 BOXCREAM113
10345-910-15ERBORIAN - CC CREME HIGH DEFINITION SPF 251 in 1 BOXCREAM113
10345-910-15ERBORIAN - CC CREME HIGH DEFINITION SPF 2515 mL in 1 TUBECREAM1513
10345-910-45ERBORIAN - CC CREME HIGH DEFINITION SPF 251 in 1 BOXCREAM113
10345-910-45ERBORIAN - CC CREME HIGH DEFINITION SPF 2545 mL in 1 TUBECREAM4513
10345-910-01ERBORIAN DOUBLE SAMPLE CC CREME CLAIR and DORE SPF 251.5 mL in 1 PACKETCREAM1.5 mL60 mg in 1mL12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
OCTISALATEACTIVE INGREDIENT4X49Y0596WERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
OCTINOXATEACTIVE MOIETY4Y5P7MUD51ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
OCTISALATEACTIVE MOIETY4X49Y0596WERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
ZINC CATIONACTIVE MOIETY13S1S8SF37ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
.ALPHA.-HEXYLCINNAMALDEHYDEINACTIVE INGREDIENT7X6O37OK2IERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
.BETA.-CITRONELLOL, (R)-INACTIVE INGREDIENTP01OUT964KERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
CENTELLA ASIATICAINACTIVE INGREDIENT7M867G6T1UERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
DISTEARDIMONIUM HECTORITEINACTIVE INGREDIENTX687XDK09LERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
EUGENOLINACTIVE INGREDIENT3T8H1794QWERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
GERANIOLINACTIVE INGREDIENTL837108USYERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
HONEYINACTIVE INGREDIENTY9H1V576FHERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
ISOMETHYL-.ALPHA.-IONONEINACTIVE INGREDIENT9XP4LC555BERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
LINALOOL, (+/-)-INACTIVE INGREDIENTD81QY6I88EERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SABERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
METHYL TRIMETHICONEINACTIVE INGREDIENTS73ZQI0GXMERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
MICAINACTIVE INGREDIENTV8A1AW0880ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H1ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
SILICA DIMETHYL SILYLATEINACTIVE INGREDIENTEU2PSP0G0WERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
TALCINACTIVE INGREDIENT7SEV7J4R1UERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
TRIHYDROXYSTEARININACTIVE INGREDIENT06YD7896S3ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]2
WATERINACTIVE INGREDIENT059QF0KO0RERBORIAN - 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
NDCDashboard titleSPL versionValidationDashboard ZIP
10345-910ERBORIAN - CC CREME HIGH DEFINITION SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LABORATOIRES M&L]13Current NDC, Legacy NDC, 7 package rows20241213_3421b9a3-6551-406f-af3a-b3da8a01d2b2.zip
10345-910ERBORIAN 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 107 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUNSCREEN SPRAY150mLZINC OXIDE 12%, TITANIUM DIOXIDE 6%, HOMOSALATE 14%, OCTISALATE 5%Foshan Sugar Max Cosmetics CO.,Ltd4635f90a-bbc9-0676-e063-6394a90a9f352025-12-18WarningsExact identifier
application number: M020
Sunscreen StickHOMOSALATE 15%, OCTISALLATE 5%, ENSULIZOLE 4%Foshan Sugar Max Cosmetics CO.,Ltd4637503c-46dc-68de-e063-6394a90abdc72025-12-18WarningsExact identifier
application number: M020
HAWAIIAN TROPIC SUNSCREEN SHEER TOUCH SPF 70AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCe78c9ae0-c2ef-12ce-e053-2995a90abf1c2025-12-18WarningsExact identifier
application number: M020
NARS PURE RADIANT TINTED MOISTURIZER CuzcoOCTINOXATE, TITANIUM DIOXIDENARS Cosmetics5bb5d035-16d9-4843-b9aa-d30730c885082025-12-18WarningsExact identifier
application number: M020
Olay Regenerist Micro-Sculpting Hydrating Moisturizer Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company248be719-edff-f40d-e063-6394a90a4ef62025-12-18WarningsExact identifier
application number: M020
Olay Complete UV 365 Daily Moisturizer Normal Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company59187729-c166-58fe-e053-2991aa0abe472025-12-18WarningsExact identifier
application number: M020
GM Collin SPF 25 UVA - UVB Urban Protection Veil SunscreenZINC OXIDE AND TITANIUM DIOXIDELaboratoires Dermo-Cosmetik Inc.4f0d44ca-09f0-4feb-b78c-77d83e75d4e22025-12-18WarningsExact identifier
application number: M020
Olay Complete UV365 Daily Moisturizer with Sunscreen Broad Spectrum SPF 30 SensitiveOCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDEThe Procter & Gamble Manufacturing Company60a304b1-eee5-408b-e053-2a91aa0a0a082025-12-18WarningsExact identifier
application number: M020
THE BOD GUARD Invisible Gel Sunscreen for BodyAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEDune Suncare, Inc.463fa1ef-d40d-d818-e063-6294a90a5e612025-12-18WarningsExact identifier
application number: M020
HAWAIIAN TROPIC SUNSCREEN CLEAR WEIGHTLESS HYDRATION SPF70AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCe686a22f-bddc-5d7c-e053-2995a90a7b282025-12-18WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC090904d1-c04c-3fca-e063-6294a90a7cc72025-12-18WarningsExact identifier
application number: M020
Bye Bye Foundation Full Coverage Moisturizer SPF 50 FairTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCb098aba3-dad6-4421-a943-e88ce5e2f8d62025-12-18WarningsExact identifier
application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Fair Ivory Fair Warm Fair Beige Medium Tan Warm Tan Rich Neutral Rich Neutral Deep Deep Bronze Deep Honey Deep MochaTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCb3260833-8b7c-4d88-a55a-8cef4938442d2025-12-18WarningsExact identifier
application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Medium Medium Tan Neutral RichTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC0a647c9a-2c71-4cd2-9503-e9ab96b857ee2025-12-18WarningsExact identifier
application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Fair Light LightMedium Medium Tan TanRich RichDeepTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCf246553e-17c2-4dba-855b-1942646bb8342025-12-18WarningsExact identifier
application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Medium Tan Warm Neutral Rich Deep Bronze Neutral Deep Deep BronzeTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC15de58a4-e2bc-425b-b50b-df2d87dd3bb42025-12-18WarningsExact identifier
application number: M020
it cosmetics Your Skin But Better CC Plus Illumination Color Correcting Illuminating Broad Spectrum SPF 50 Plus Sunscreen Full Coverage FairLight NeutralTan RichHoney LightMedium and NeutralMediumTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCf493c3ea-41b3-4625-84a6-fab545a769402025-12-18WarningsExact identifier
application number: M020
YOUR SKIN BUT BETTER FAIRTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC472f34c5-cefe-4884-9475-fd0666c925ac2025-12-18WarningsExact identifier
application number: M020
First Aid Beauty FAB Broad Spectrum Sunscreen SPF 30OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDEThe Procter & Gamble Manufacturing Companyd7238996-374b-07aa-e053-2995a90ae8892025-12-18WarningsExact identifier
application number: M020
Olay Regenerist Hyaluronic plus Peptide 24 Hydrating Moisturizer with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Companyeadacdae-3901-3f7c-e053-2a95a90ab1842025-12-18WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10345-910-01103450910011.5 mL in 1 PACKET (10345-910-01) 1.5 ml2017-12-030000-00-00YesNoCurrent
10345-910-05103450910051 TUBE in 1 BOX (10345-910-05) / 5 mL in 1 TUBE1 tube2018-07-010000-00-00NoNoCurrent
10345-910-15103450910151 TUBE in 1 BOX (10345-910-15) / 15 mL in 1 TUBE1 tube2015-02-060000-00-00NoNoCurrent
10345-910-45103450910451 TUBE in 1 BOX (10345-910-45) / 45 mL in 1 TUBE1 tube2015-02-060000-00-00NoNoCurrent