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 221 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEB SPF 50 Mangonada Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B3147ef18-9029-6d5b-e063-6394a90acee02025-03-26WarningsExact identifier
application number: M020
HEB SPF 50 Mexican Vanilla Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B31487bad-a756-9050-e063-6394a90acacc2025-03-26WarningsExact identifier
application number: M020
TRADER JOES DAILY FACIAL MINERAL SUNSCREEN SPF 40ZINC OXIDETrader Joe's Company3148c00f-21bb-c05f-e063-6394a90af0e82025-03-26WarningsExact identifier
application number: M020
HEB SPF 50 Chamomile and Lavender Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B314b8147-fe7a-0698-e063-6394a90a872c2025-03-26WarningsExact identifier
application number: M020
HEB SPF 50 Shine Sunscreen with Vitamin C Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B314bcf42-ca01-0fa5-e063-6294a90a5fc82025-03-26WarningsExact identifier
application number: M020
Superactive Moisturizer SPF 50 Hydrating SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMurad, LLC1e5d494b-dccf-4ba1-89de-0bb4ba5b8d382025-03-26WarningsExact identifier
application number: M020
Superactive Moisturizer SPF 50 Wrinkle Fighting SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEMurad, LLCac6163fb-dbc1-432f-a590-86d31c93b29b2025-03-26WarningsExact identifier
application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep FairLight Neutral Tan Rich Honey LightMedium and Neutral MediumTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCe17dc640-30e9-441b-a212-ef1508af79442025-03-25WarningsExact identifier
application number: M020
Lip Balm SPF15 VanillaLIP BALM SPF15 VANILLALS Promotions Inc312d0dc5-3933-ecfe-e063-6294a90a9b662025-03-25WarningsExact identifier
application number: M020
Lip Balm SPF15 Blueberry CobblerLIP BALM SPF15 BLUEBERRY COBBLERLS Promotions Inc312fb7b0-86a9-ca88-e063-6294a90a76c82025-03-25WarningsExact identifier
application number: M020
Lip Balm SPF15 PeppermintLIP BALM SPF15 PEPPERMINTLS Promotions Inc3130be1c-0167-2389-e063-6394a90aa61d2025-03-25WarningsExact identifier
application number: M020
Drs. pharmacy sunscreen SPF 30SUNSCREEN SPF 30OL PHARMA TECH LLC. (Drs. Pharmacy)052dea5d-a775-8dc2-e063-6294a90a4f192025-03-25WarningsExact identifier
application number: M020
Drs. pharmacy sunscreen SPF 50SUNSCREEN SPF 50OL PHARMA TECH LLC. (Drs. Pharmacy)0def5c19-b088-2ffb-e063-6394a90aa1092025-03-25WarningsExact identifier
application number: M020
Drs. pharmacy sunscreen SPF 70SUNSCREEN SPF 70OL PHARMA TECH LLC. (Drs. Pharmacy)0def6fa1-b028-fad5-e063-6394a90a19132025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50 -84521ZINC OXIDEe.l.f. Cosmetics, Inc.31329426-d952-ee5d-e063-6294a90a55f42025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50 -84520ZINC OXIDEe.l.f. Cosmetics, Inc.31328845-9a67-d237-e063-6294a90a2a7f2025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50 -84519ZINC OXIDEe.l.f. Cosmetics, Inc.31327ea3-affd-ca13-e063-6294a90a72382025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50 -84517ZINC OXIDEe.l.f. Cosmetics, Inc.3132641a-e593-a9e8-e063-6294a90acc802025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50 -84518ZINC OXIDEe.l.f. Cosmetics, Inc.3132669c-e104-ae1e-e063-6294a90aee7f2025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84514ZINC OXIDEe.l.f. Cosmetics, Inc.31324410-3142-89e1-e063-6294a90a22ee2025-03-25WarningsExact 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