FDA.reportPublic FDA data

Centella Calming SUNSCREEN

Product NDC
84558-007
11-digit product format
845580007
Labeler code
84558
Product ID
84558-007_2dc0eea5-98b2-d312-e063-6294a90ab0e1
Type
HUMAN OTC DRUG
Nonproprietary name
Centella Calming SUNSCREEN
Dosage form
CREAM
Route
CUTANEOUS
Labeler
GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-10
Substance
TITANIUM DIOXIDE; ETHYLHEXYL SALICYLATE; PHENYLBENZIMIDAZOLE SULFONIC ACID; ZINC OXIDE
Active strength
2.76; 5; 3.2; 2.85 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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 Calming SUNSCREEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE2.76 g/100mL
ETHYLHEXYL SALICYLATE5 g/100mL
PHENYLBENZIMIDAZOLE SULFONIC ACID3.2 g/100mL
ZINC OXIDE2.85 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
4X49Y0596WInternal UNII lookup
9YQ9DI1W42Internal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2dc0ee9b-d58b-fe40-e063-6394a90af439Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84558-007-01Centella Calming SUNSCREEN60 mL in 1 BOTTLECREAM601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84558-007CENTELLA CALMING SUNSCREEN CREAM [GUANGZHOU YUSONG FINE CHEMICLS CO., LTD]1Current NDC, 1 package rows20250212_2dc0ee9b-d58b-fe40-e063-6394a90af439.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 163 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunsovle MD Volumize and RestoreZINC OXIDESunsolve MD Inc26f3cdda-b990-15cb-e063-6394a90ade292025-11-14WarningsExact identifier
application number: M020
Naturium Dew-Glow Moisturizer SPF 50HOMOSALATE, OCTISALATE, AVOBENZONEe.l.f. Cosmetics, Inc0a5b80fb-caeb-eb56-e063-6294a90a238b2025-11-14WarningsExact identifier
application number: M020
Naturium Dew Glow Tinted Moisturizer SPF50HOMOSALATE, OCTISALATE, AVOBENZONEe.l.f. Cosmetics, Inc.0d82f310-f87a-f76d-e063-6294a90af2512025-11-14WarningsExact identifier
application number: M020
Naturium Dew Glow Tinted Moisturizer SPF50-deepHOMOSALATE, OCTISALATE, AVOBENZONEe.l.f. Cosmetics, Inc.0d865e74-1baf-6a44-e063-6394a90a37ac2025-11-14WarningsExact identifier
application number: M020
Naturium Dew Glow Tinted Moisturizer SPF50-mediumHOMOSALATE, OCTISALATE, AVOBENZONEe.l.f. Cosmetics, Inc.0d8616a8-2eab-c85c-e063-6294a90a39842025-11-14WarningsExact identifier
application number: M020
Naturium UV Reflect Antioxidant SPF 50HOMOSALATE, OCTISALATE, AVOBENZONEe.l.f. Cosmetics, Inc0a5c6fc8-6cdc-0ae5-e063-6394a90ae01c2025-11-14WarningsExact identifier
application number: M020
CERAVE DEVELOPED WITH DERMOTOLOGISTS Invisible Mineral Sunscreen FOR ALL SKIN TYPES AND TONES FACE UVB AND UVA BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc372894af-bed7-474f-95d4-69a8c3f215ef2025-11-14WarningsExact identifier
application number: M020
HEIMISH RX HYALURONIC ACID HYDRATING SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEONEAND CO., LTD.2dc41560-f4a7-5f0b-e063-6294a90a06302025-11-13WarningsExact identifier
application number: M020
Covey Sun and Done Daily MoisturizingZINC OXIDECovey Skinfbcf8204-0673-99aa-e053-6294a90ac26e2025-11-13WarningsExact identifier
application number: M020
SOL Science The FiftyZINC OXIDEBeauty Pie01548858-8b0e-494a-e063-6294a90a8e992025-11-13WarningsExact identifier
application number: M020
Balmere Mineral Sunscreen Moisturizer PrimerZINC OXIDEBalmere00d813e0-eb97-a6ba-e063-6394a90aa5252025-11-13WarningsExact identifier
application number: M020
Dove Clinical Care96H PROTECTION FRESH PEACH DRY SPRAY ANTIPERSPIRANT DEODORANTConopco d/b/a Unilever437eb2a8-428c-8339-e063-6394a90a74b22025-11-13WarningsExact identifier
application number: M020
Dove Clinical Care96H PROTECTION ORIGINAL CLEAN DRY SPRAY ANTIPERSPIRANT DEODORANTConopco d/b/a Unilever437f4db5-552f-1550-e063-6394a90aaedb2025-11-13WarningsExact identifier
application number: M020
Depology Essential Mineral UV CareZINC OXIDEDepology Holdings LLC1d48cdee-be67-14c0-e063-6294a90a74222025-11-13WarningsExact identifier
application number: M020
Hanalei Face MoisturizingZINC OXIDEHanalei Beauty Company LLC1f7c1a68-5aea-0deb-e063-6394a90a3a432025-11-13WarningsExact identifier
application number: M020
Glo SkinTITANIUM DIOXIDE, ZINC OXIDEGlo Skin Beautyf4bed574-68c1-0d2c-e053-2a95a90a15ff2025-11-13WarningsExact identifier
application number: M020
Dove Clinical Care96H PROTECTION SOFT SENSITIVE DRY SPRAY ANTIPERSPIRANT DEODORANTConopco d/b/a Unilever4380036a-7698-03e7-e063-6294a90a73012025-11-13WarningsExact identifier
application number: M020
SOME BY MI V10 HYAL AIR FIT SUNSCREENSUNSCREENTPERENNEBELLfe2148db-9020-9343-e053-6294a90adf702025-11-13WarningsExact identifier
application number: M020
skin MDOCTINOXATE, OCTISALATE, HOMOSALATE21st Century Formulationse809e1d3-0a6d-730d-e053-2a95a90aedb92025-11-13WarningsExact identifier
application number: M020
Obagi Nu-Derm Fx System Normal-Oily Skin Transformation Complexion Brightening SystemTITANIUM DIOXIDE, ZINC OXIDEObagi Cosmeceuticals LLCa64045dd-8f70-43f1-be6f-ad1556c0e2102025-11-13WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84558-007-018455800070160 mL in 1 BOTTLE (84558-007-01) 60 ml2025-02-10NoNoCurrent