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 219 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROSA ROMANTICA FEMME) - PINKOCTINOXATE AND OXYBENZONEVentura Corporation LTDaa79b1a4-6b33-47c9-b55e-b813d9b222652025-04-09WarningsExact identifier
application number: M020
Brush On Block SPF 30 Mineral Powder Touch of Tan Zinc OnlyZINC OXIDESPF Ventures, LLC3240cbe5-bfc8-17f7-e063-6394a90a1b982025-04-08WarningsExact identifier
application number: M020
ISA KNOX UV SUN PRO 365 Sheer Mineral FaceZINC OXIDELG HOUSEHOLD & HEALTH CARE LTD.2eeac795-b74e-b3a3-e063-6294a90abf522025-04-08WarningsExact identifier
application number: M020
The Face Shop Hydro Sun Barrier 2-in-1 SPF and MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.2ee9f271-b508-2304-e063-6294a90a37522025-04-08WarningsExact identifier
application number: M020
CLARINS Multi-Active Jour Niacinamide and Sea Holly Extract Sunscreen SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELaboratoires Clarinsa43d0d4f-94de-4c4b-a17a-63a819d5d2932025-04-07WarningsExact identifier
application number: M020
Gangnam Glow Sunscreen 50AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.30cc2e35-f752-8285-e063-6294a90afbf52025-04-07WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.26f8dc88-2096-4fa1-81ae-ea92fe1f353d2025-04-07WarningsExact identifier
application number: M020
Vacation Instant BrowningAVOBENZONE OCTISALATE OCTOCRYLENEVacation Inc.13028f61-3f62-22cc-e063-6394a90a6bf12025-04-04WarningsExact identifier
application number: M020
LBri Pure n Natural SPF 30ZINC OXIDEL'BRI HEALTH & BEAUTY8350791d-5cf2-4358-9f85-9384d35be9f42025-04-03WarningsExact identifier
application number: M020
SHEER MINERAL SUNSCREENZINC OXIDEPlant Devas Inc. dba evanhealyf620ef44-f30c-4cc9-bc82-28dc4a47a8da2025-04-02WarningsExact identifier
application number: M020
CLEAR GLOW BROAD SPECTRUM SUNCREEN SPF 50AVOBENZONE, HOMOSALATE OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTD0116cffa-3415-746b-e063-6394a90ab3b32025-04-01WarningsExact identifier
application number: M020
HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50AVOBENZONE, HOMOSALATE OCTISALATE,NAKED SUNDAYS PTY LTD04293280-e74a-f293-e063-6394a90a06f62025-04-01WarningsExact identifier
application number: M020
Glow Go Lip OilAVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G,NAKED SUNDAY PTY LTDe5aab267-b33b-a40d-e053-2a95a90a9d792025-04-01WarningsExact identifier
application number: M020
Glow Go Lip OilAVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G,NAKED SUNDAY PTY LTDe5beb9cd-aa3b-2b37-e053-2995a90a84092025-04-01WarningsExact identifier
application number: M020
Glow Go Lip OilAVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G,NAKED SUNDAY PTY LTDe5bdc0c8-af2c-1096-e053-2995a90a89172025-04-01WarningsExact identifier
application number: M020
Mesoestetic Mesoprotech Melan 130 Pigment ControlAVOBENZONE, HOMOSALATE, OCTOCRYLENEMESOESTETIC PHARMA GROUP SL3b50e874-9665-4df4-8b3a-fc932c29f3f62025-04-01WarningsExact identifier
application number: M020
AVON BEYOND GLOW SUN MOISTURIZERAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.30c83f4f-9de0-6fbf-e063-6394a90af1ae2025-04-01WarningsExact identifier
application number: M020
EltaMD UV DailyOCTINOXATE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc6dde7055-5f77-4a7f-a182-c03e1f30bfaa2025-03-31WarningsExact identifier
application number: M020
natural lip balm SPF15( chocolate sundae) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.319e8e26-b29d-4627-e063-6294a90acfba2025-03-31WarningsExact identifier
application number: M020
Face Shield Cream SPF 30OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONEVege Labs31aad575-a5d1-42b0-e063-6294a90a6c812025-03-31WarningsExact 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