FDA.reportPublic FDA data

CENTELLA RELIEF SOOTHING SUNSCREEN

Product NDC
83403-100
11-digit product format
834030100
Labeler code
83403
Product ID
83403-100_47d170e3-dd77-d413-e063-6294a90ae8e4
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
IUNIK Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-07
Substance
OCTOCRYLENE; AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
9; 2.85; 7; 4.5 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
CENTELLA RELIEF SOOTHING SUNSCREEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE9 g/100mL
AVOBENZONE2.85 g/100mL
HOMOSALATE7 g/100mL
OCTISALATE4.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal 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
47d170e3-dd76-d413-e063-6294a90ae8e4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83403-100-01CENTELLA RELIEF SOOTHING SUNSCREEN60 mL in 1 TUBELOTION601
83403-100-02CENTELLA RELIEF SOOTHING SUNSCREEN1 in 1 BOXLOTION11

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 328 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. C. Tuna Resurface Essential Day CreamHOMOSALATE, OCTINOXATE, OCTOCRYLENE, AVOBENZONEFarmasi US LLCb92ff1e9-9dc4-46cb-a99d-98ff15bffc792023-11-05WarningsExact identifier
application number: M020
Dr C Tuna Sun protector lip balm SPF 15HOMOSALATE, OCTINOXATEFarmasi US LLCddcd82b5-9ad2-2340-e053-2a95a90a4fc02023-11-05WarningsExact identifier
application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 04 Medium to TanTITANIUM DIOXIDEFarmasi US LLCdeee5784-c68b-4cd7-acbf-f64391a01bfc2023-11-05WarningsExact identifier
application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 02 Light to MediumTITANIUM DIOXIDEFarmasi US LLCcef1a926-b7d4-47d6-957d-e3092e60970c2023-11-05WarningsExact identifier
application number: M020
Dr. C. Tuna Lumi Radiance Brightening CreamOCTOCRYLENE, OCTINOXATE, AVOBENZONEFarmasi US LLCb55790f7-20f2-404e-9a0e-5e76c383bf752023-11-05WarningsExact identifier
application number: M020
Dr. C. Tuna Lumi Radiance Brightening Cream 22 SPFOCTOCRYLENE, OCTINOXATE, AVOBENZONEFarmasi US LLCde493e30-d10e-9def-e053-2995a90ae49a2023-11-05WarningsExact identifier
application number: M020
Dr. C. Tuna Sun Face and Body SPF 50AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATEFarmasi US LLC141f9d22-deb7-4b6b-97b5-ee21898b96f72023-11-05WarningsExact identifier
application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 06 DeepTITANIUM DIOXIDEFarmasi US LLC2f13a160-740f-4b09-8858-e438a9ba303e2023-11-05WarningsExact identifier
application number: M020
Dr. C. Tuna Sun Bronzing Oil SPF 6OCTINOXATEFarmasi US LLC91b428cc-1c80-4d56-8450-790c66de41332023-11-05WarningsExact identifier
application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 05 TanTITANIUM DIOXIDEFarmasi US LLC3f494921-844e-4010-ab0c-144c8dce8aca2023-11-05WarningsExact identifier
application number: M020
Farmasi CC Color Control Cream SPF 25TITANIUM DIOXIDEFarmasi US LLCf4fcfc78-9591-4a20-b9fb-88e1dc9b221d2023-11-05WarningsExact identifier
application number: M020
Farmasi CC Color Control Cream SPF 25- 02 Light to MediumTITANIUM DIOXIDEFarmasi US LLC0d913242-2e57-4ba7-a718-154af68480b22023-11-05WarningsExact identifier
application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 03 MediumTITANIUM DIOXIDEFarmasi US LLC6ef986df-4044-4c32-8b64-f8110c9c95432023-11-05WarningsExact identifier
application number: M020
Farmasi CC Color Control Cream SPF 25- 04 Medium to TanTITANIUM DIOXIDEFarmasi US LLCde24317f-2cf0-4125-bb17-c3d6b3c22e002023-11-05WarningsExact identifier
application number: M020
Farmasi CC Color Control Cream SPF 25- 05 TanTITANIUM DIOXIDEFarmasi US LLC22842793-ae1f-4b71-8db9-34c06dc37daa2023-11-05WarningsExact identifier
application number: M020
Farmasi CC Color Control Cream SPF 25- 03 MediumTITANIUM DIOXIDEFarmasi US LLC9f203e7f-3bba-4f36-a35a-6d9466e390822023-11-05WarningsExact identifier
application number: M020
Farmasi CC Color Control Cream SPF 25- 06 DeepTITANIUM DIOXIDEFarmasi US LLCc28afa3b-9a8d-4e19-bc6b-39cc8428c9f92023-11-05WarningsExact identifier
application number: M020
DR. C Tuna Sunscreen 30 SPF Broad Spectrum Face and bodyAVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATETAN-ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETIa71ee8e0-2d27-7ae6-e053-2a95a90aecd42023-11-05WarningsExact identifier
application number: M020
PHARMACA Natural Mineral Sunscreen SPF-50TITANIUM DIOXIDE, ZINC OXIDEPharmaca Integrative Pharmacy, Inc.51e6cd7a-5c9a-4666-9021-ade42eb064cd2023-11-05WarningsExact identifier
application number: M020
Dr.C.Tuna Sun Face Cream SPF50AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENETan Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret Anonim Sirketif668c078-61e6-2c81-e053-2a95a90a31002023-11-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83403-100-018340301000160 mL in 1 TUBE60 mlHistorical
83403-100-02834030100021 TUBE in 1 BOX (83403-100-02) / 60 mL in 1 TUBE (83403-100-01) 1 tube2026-01-07NoNoCurrent