FDA.reportPublic FDA data

ERBORIAN CC RED CORRECT

Product NDC
83573-100
11-digit product format
835730100
Labeler code
83573
Product ID
83573-100_3f1c4a45-0856-d1c3-e063-6294a90a3592
Type
HUMAN OTC DRUG
Nonproprietary name
ERBORIAN CC RED CORRECT SPF 25- octinoxate, octisalate, titanium dioxide, zinc oxide cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Kolmask Co., Ld.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-13
Marketing end
2026-12-19
Substance
OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE; OCTISALATE
Active strength
60; 23.4; 38.4; 20 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
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 RED CORRECT

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE60 mg/mL
TITANIUM DIOXIDE23.4 mg/mL
ZINC OXIDE38.4 mg/mL
OCTISALATE20 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
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
09ca2d4b-e0c2-9961-e063-6394a90aa82eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83573-100-44ERBORIAN CC RED CORRECT45 mL in 1 TUBECREAM453
83573-100-45ERBORIAN CC RED CORRECT1 in 1 BOXCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83573-100ERBORIAN CC RED CORRECT (ERBORIAN CC RED CORRECT SPF 25- OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM) CREAM [KOLMASK CO., LD.]2Current NDC, 2 package rows20241212_09ca2d4b-e0c2-9961-e063-6394a90aa82e.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 153 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRO-TECT SPORTS SUNSCREENMERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONEBio-Medical & Pharmaceutical Manufacturing Corporation66bb06fb-33d2-4b57-a65f-66bcd187c6272025-12-03WarningsExact identifier
application number: M020
PRO-TECT SUNSCREEN FOR PROFESSIONALSMERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONEBio-Medical & Pharmaceutical Manufacturing Corporation374e172b-90e8-4fca-8934-dee3ed7b599d2025-12-03WarningsExact identifier
application number: M020
LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 BERRY UNIVERSELOCTINOXATE, ZINC OXIDEBEL STAR S A25b6cb46-6516-376a-e063-6394a90a44f62025-12-03WarningsExact identifier
application number: M020
LBEL LUMI AGE ANTI AGING NOURISHING FACIAL WITH SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBEL STAR SA4510cd0d-40b8-f452-e063-6394a90a44e52025-12-03WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC45117885-c674-b58a-e063-6394a90af5f42025-12-03WarningsExact identifier
application number: M020
CANNON BALMOCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEDUKE CANNON SUPPLY CO.f70a0173-c8ba-da7c-e053-6294a90a67db2025-12-03WarningsExact identifier
application number: M020
CANNON BALM 140AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEDUKE CANNON SUPPLY CO.f70c8632-ed11-0cc3-e053-6394a90a77db2025-12-03WarningsExact identifier
application number: M020
Omega-Boost Sheer Mineral SunscreenMINERAL SUNSCREENTrilogy Natural Products Limited0405b7a6-6885-ed93-e063-6294a90a93862025-12-03WarningsExact identifier
application number: M020
Poolside Hot Head SPF 30 hair scalp sunscreen mistHOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.4517da75-c91a-1f93-e063-6394a90a65ac2025-12-03WarningsExact identifier
application number: M020
Poolside Tropic Touch SPF 30 Sunscreen Body spray.HOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.4517ef95-8ea1-3de6-e063-6394a90a2c792025-12-03WarningsExact identifier
application number: M020
Poolside Orange Creme SPF 30 Sunscreen oil mistHOMOSALATE 15%, OCTOCRYLENE 10%, OCTISALATE 5%, AVOBENZONE 3%Longway Technology(Guangzhou)Co.,Ltd.4517fd05-ea60-0492-e063-6294a90a28e92025-12-03WarningsExact identifier
application number: M020
e.l.f. All Set For Sun SPF 45 SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.26f43446-e5ee-57a5-e063-6394a90a86612025-12-03WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC7678467a-9da3-1b51-e053-2991aa0a568f2025-12-02WarningsExact identifier
application number: M020
Cardinal Health Leader General Protection SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENECARDINAL HEALTH, INC.b60cf360-7c8d-5da4-e053-2995a90a24c22025-12-02WarningsExact identifier
application number: M020
Cardinal Health Leader General Protection Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH, INC.b6107d22-a992-eaa1-e053-2995a90a29c22025-12-02WarningsExact identifier
application number: M020
Cardinal Health Leader General Protection Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH, INC.b623defb-4a9d-6fc5-e053-2995a90ae8462025-12-02WarningsExact identifier
application number: M020
Cardinal Health Leader Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH, INC.b62329d7-29e9-d111-e053-2a95a90aab062025-12-02WarningsExact identifier
application number: M020
Leader Ultra Sheer SPF 100 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECARDINAL HEALTH, INC.b5a467e0-a6ab-4136-8101-f22cc319de582025-12-02WarningsExact identifier
application number: M020
Leader General Protection SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH, INC.9544b046-055e-5886-e053-2a95a90ad09e2025-12-02WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC44fe0844-cb74-7a04-e063-6294a90aca152025-12-02WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83573-100-448357301004445 mL in 1 TUBE45 mlHistorical
83573-100-45835730100451 TUBE in 1 BOX (83573-100-45) / 45 mL in 1 TUBE (83573-100-44) 1 tube2023-11-132026-12-19NoNoHistorical