FDA.reportPublic FDA data

CENTELLA RELIEF SOOTHING SUNSCREEN

Manufacturer
IUNIK Co., Ltd. | COSMAX, INC.
Effective date
2026-01-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:31:44

Label at a glance#

ProductCENTELLA RELIEF SOOTHING SUNSCREEN
Active ingredientOCTOCRYLENE, AVOBENZONE, HOMOSALATE, OCTISALATE
Label structure8 sections

Indications and uses

- Helps prevent sunburn. - If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Sun protection measures. - Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m.–2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses. Children ...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.84%

Homosalate 7.0 %

Octisalate 4.5%

Octocrylene 9.0%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

- Helps prevent sunburn.

- If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.

WARNINGS

WARNINGS SECTION

  • For external use only.
  • Do not use on damaged or broken skin.
  • When using this product, keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

- If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Sun protection measures.
    - Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m.–2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months of age: Ask a doctor.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Tripropylene Glycol, Propanediol, Silica, Ethylhexyl Methoxycrylene, Diethylhexy 2,6-Naphthalate, 1,2-Hexanediol, Enantia Chlorantha Bark Extract, Centella Asiatica Extract, Centella Asiatica Leaf Extract, Centella Asiatica Root Extract, Saccharomyces Ferment, Dimethicone, Methyl Trimethicone, Pentylene Glycol, Hydroxyethyl Urea, Poly C10-30 Alky Acrylate, Cetearyl Olivate, Polyacrylic Acid, Tromethamine, Sorbitan Olivate, Dipotassium Phosphate, Acetyl Glutamine, Sodium Stearoyl Glutamate, Butylene Glycol, Ethylhexylglycerin, Cellulose Gum, Tocopherol, Oleanolic Acid, Asiatic Acid, Asiaticoside, Madecassic Acid, Madecassoside, Cetyl Alcohol, Carborer, Xanthan Gum

CENTELLA RELIEF SOOTHING SUNSCREEN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CENTELLA RELIEF SOOTHING SUNSCREENCENTELLA RELIEF SOOTHING SUNSCREEN

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83403-10083403-100-01, 83403-100-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIPROPYLENE GLYCOL3C8845E7C1IACT
MADECASSOSIDECQ2F5O6YIYIACT
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
METHYL TRIMETHICONES73ZQI0GXMIACT
CARBOMER0A5MM307FCIACT
CENTELLA ASIATICA ROOT8MXU1P42J0IACT
ASIATICOSIDEPKO39VY215IACT
SACCHAROMYCES CEREVISIAE978D8U419HIACT
SILICAETJ7Z6XBU4IACT
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
MADECASSIC ACIDM7O1N24J82IACT
HOMOSALATEV06SV4M95SACTIB
TOCOPHEROLR0ZB2556P8IACT
PROPANEDIOL5965N8W85TIACT
BEHENYL ACRYLATE POLYMERD64PM5UT4UIACT
CETYL ALCOHOL936JST6JCNIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
CELLULOSE GUMK679OBS311IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
OLEANOLIC ACID6SMK8R7TGJIACT
ASIATIC ACID9PA5A687X5IACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
HYDROXYETHYL UREAMBQ7DDQ7ARIACT
CETEARYL OLIVATE58B69Q84JOIACT
TROMETHAMINE023C2WHX2VIACT
OCTISALATE4X49Y0596WACTIB
SORBITAN OLIVATEMDL271E3GRIACT
ACETYL GLUTAMINE01J18G9G97IACT
XANTHAN GUMTTV12P4NEEIACT
ANNICKIA CHLORANTHA BARKH70115MP4AIACT
CENTELLA ASIATICA7M867G6T1UIACT
PENTYLENE GLYCOL50C1307PZGIACT
DIBASIC POTASSIUM PHOSPHATECI71S98N1ZIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CENTELLA RELIEF SOOTHING SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEIUNIK Co., Ltd.47d170e3-dd76-d413-e063-6294a90ae8e42026-01-07WarningsExact identifier
ndc (package): 83403-100-02
ndc (package): 83403-100-01
ndc (product): 83403-100
ndc11 (package): 83403010001
ndc11 (package): 83403010002
spl id: 47d170e3-dd77-d413-e063-6294a90ae8e4
spl set id: 47d170e3-dd76-d413-e063-6294a90ae8e4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.