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 168 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 55 ClubtrayAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC0bd538e9-7716-9bc2-e063-6294a90a9a072025-11-06WarningsExact identifier
application number: M020
Aveeno Positively Radiant Daily Moisturizer Sunscreen Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLCdd9ebc46-0fa4-5d96-e053-2995a90a79182025-11-06WarningsExact identifier
application number: M020
Hawaiian Tropic Mineral Face Skin Nourishing Tinted Milk Coconut Oil SPF30TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCeeb3c173-b280-76e4-e053-2995a90a0e792025-11-06WarningsExact identifier
application number: M020
SPF 50 Sunscreen StickZINC OXIDEELEEO BRANDS LLC09cf0f04-961e-4430-91bb-224e7fed13ef2025-11-06WarningsExact identifier
application number: M020
Hawaiian Tropic Mineral Skin Nourishing Milk Coconut Oil SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCefcd52c2-4208-46a1-e053-2a95a90a857d2025-11-06WarningsExact identifier
application number: M020
Peachy Mineral Facial SunscreenZINC OXIDEPeachy Corp42efead0-0e11-7270-e063-6394a90a4eb92025-11-06WarningsExact identifier
application number: M020
Peachy Tinted Facial SunscreenZINC OXIDEPeachy Corp42f0fb68-c0bf-cf98-e063-6294a90ab7032025-11-06WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands, LLC764401f3-4219-6e9b-e053-2991aa0a3ed22025-11-06WarningsExact identifier
application number: M020
Banana Boat Sport coolzone Clear Sunscreen Broad Spectrum SPF 30AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCab7102ba-1020-3f51-e053-2995a90ae24d2025-11-06WarningsExact identifier
application number: M020
Banana Boat Sunscreen Lip Balm UVA/UVB Broad Spectrum SPF 45AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCc794592c-d24e-4530-e053-2995a90a7e4d2025-11-06WarningsExact identifier
application number: M020
Green Envee Radiance SheerZINC OXIDEGreen Envee42f1908f-2787-c4e5-e063-6294a90afcd02025-11-06WarningsExact identifier
application number: M020
Indie Lee Daily PrimerZINC OXIDEAmerica Exchange38e5232b-7daf-7e61-e063-6394a90aa5b02025-11-06WarningsExact identifier
application number: M020
Duette UntintedZINC OXIDESkin Theory Studios3ce24b39-8bb1-1246-e063-6294a90a32d42025-11-06WarningsExact identifier
application number: M020
Duette TintedZINC OXIDESkin Theory Studios3ce1d7cb-b37d-fb9f-e063-6394a90aaef32025-11-06WarningsExact identifier
application number: M020
Truskin Broad Spectrum Mineral Sunscreen Facial Serum with Vitamin C and AloeZINC OXIDEAllure Labs42f3999f-4163-fadc-e063-6294a90aacf32025-11-06WarningsExact identifier
application number: M020
Melan RXZINC OXIDEMelan RXf4bdf20c-b6bc-55f1-e053-2995a90ac3082025-11-06WarningsExact identifier
application number: M020
ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FUCSIA CAUTIVANTE EXOTIC) - PINKOCTINOXATE AND OXYBENZONEVentura Corporation LTDe1eb77f1-d65c-4af8-a7d9-90f10570960f2025-11-06WarningsExact identifier
application number: M020
Ultraceuticals Ultra UV Protective Daily MoisturisingZINC OXIDEUltraceuticalsfc8a5c02-23b4-b4d8-e053-6294a90a55ea2025-11-06WarningsExact identifier
application number: M020
Vaihea Protect Clean SPF DropsZINC OXIDEVaihea Skincare LLCfe7e3145-a8e2-d14f-e053-6394a90abb5e2025-11-06WarningsExact identifier
application number: M020
Refy Skin TrioZINC OXIDERefy3029a690-dbb0-ff15-e063-6394a90abdbe2025-11-06WarningsExact 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