FDA.reportPublic FDA data

ERBORIAN CC CREME Color Correcting SPF 25 FAIR

Product NDC
10345-950
11-digit product format
103450950
Labeler code
10345
Product ID
10345-950_3c151cd8-d00e-35b6-e063-6294a90a9013
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
2025-09-01
Substance
OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength
60; 20; 15.6; 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 Color Correcting SPF 25 FAIR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE60 mg/mL
OCTISALATE20 mg/mL
TITANIUM DIOXIDE15.6 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
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal 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
4443d4e6-bdc9-4547-9189-e94e9e0bdd2dAvailable 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
10345-950-05ERBORIAN CC CREME Color Correcting SPF 25 FAIR1 in 1 BOXCREAM11
10345-950-05ERBORIAN CC CREME Color Correcting SPF 25 FAIR5 mL in 1 TUBECREAM51
10345-950-15ERBORIAN CC CREME Color Correcting SPF 25 FAIR15 mL in 1 TUBECREAM151
10345-950-15ERBORIAN CC CREME Color Correcting SPF 25 FAIR1 in 1 BOXCREAM11
10345-950-45ERBORIAN CC CREME Color Correcting SPF 25 FAIR45 mL in 1 TUBECREAM451
10345-950-45ERBORIAN CC CREME Color Correcting SPF 25 FAIR1 in 1 BOXCREAM11

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 39 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDRA SPF 34HOMOSALATE, OCTYL SALICYLATE, AVOBENZONEDrmtlgy, LLC31e41ed5-8498-4e2d-928a-c15ca99775e42026-04-21WarningsExact identifier
application number: M020
FORGESKINMINERAL TALLOW SUNSCREENGUANGZHOU KANGLIXIN BIOTECHNOLOGY CO.,LTD4fe913f4-b0be-dc53-e063-6294a90a363c2026-04-20WarningsExact identifier
application number: M020
ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUMAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.228dcd68-aaba-0451-e063-6394a90a8ad02026-04-20WarningsExact identifier
application number: M020
Biore Aqua Rich UVOCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATEKAO USAf900db18-5fe2-1d74-e053-6394a90a3ca22026-04-20WarningsExact identifier
application number: M020
Biore UV Aqua RichOCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATEKAO USA2bc23bb5-86bb-7915-e063-6394a90a9d722026-04-20WarningsExact identifier
application number: M020
ETUDE SunPrise Mild Airy Finish SunstickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEETUDE CORPORATION25abc744-5b62-acb4-e063-6394a90af1102026-04-19WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c7c399-b05e-2545-e053-2995a90ac6112026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c7c399-b060-2545-e053-2995a90ac6112026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c7d9f4-986f-70f7-e053-2a95a90a4f8a2026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c81845-afcb-18ac-e053-2a95a90abdbe2026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c83245-a40c-8f05-e053-2a95a90a05212026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c84047-fd3b-ea66-e053-2a95a90ae9aa2026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c623aa-3846-b7f4-e053-2995a90aecb52026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c585ff-88de-e29c-e053-2a95a90af4d42026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c852de-4c36-6d93-e053-2995a90aff612026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c86288-bb22-03b1-e053-2995a90a31612026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c8742f-1060-48bc-e053-2995a90a31c22026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c4eedc-12a0-6418-e053-2a95a90a55e72026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c8849a-6624-6987-e053-2a95a90a45462026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c8ac70-a8c8-2f07-e053-2a95a90a3d012026-04-18WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10345-950-05103450950051 TUBE in 1 BOX (10345-950-05) / 5 mL in 1 TUBE1 tube2025-09-01NoNoCurrent
10345-950-15103450950151 TUBE in 1 BOX (10345-950-15) / 15 mL in 1 TUBE1 tube2025-09-01NoNoCurrent
10345-950-45103450950451 TUBE in 1 BOX (10345-950-45) / 45 mL in 1 TUBE1 tube2025-09-01NoNoCurrent