FDA.reportPublic FDA data

CLARINS Multi-Active Jour Niacinamide and Sea Holly Extract Sunscreen SPF 15

Manufacturer
Laboratoires Clarins
Effective date
2025-04-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:58:46

Label at a glance#

ProductCLARINS Multi-Active Jour Niacinamide and Sea Holly Extract Sunscreen SPF 15
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

apply liberally 15 minutes before sun exposure apply to all skin exposed to the sun children under 6 months: Ask a doctor 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 broad spectrum SPF of 15 or higher and other sun protection measures including:  limit time in the sun, especially from 10 a.m. – 2 p....

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

AVOBENZONE 3%. HOMOSALATE 7%. OCTISALATE 5%. OCTOCRYLENE 7%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions),decreases the risk of skin cancer and early skin aging caused by the sun

Warnings:

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs.

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
  • apply to all skin exposed to the sun
  • children under 6 months: Ask a doctor
  • 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 broad spectrum SPF 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
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating

Inactive ingredients:

INACTIVE INGREDIENT SECTION

AQUA/WATER. GLYCERIN. BETAINE. POLYGLYCERYL-6 STEARATE. PENTYLENE GLYCOL. DICAPRYLYL CARBONATE. NIACINAMIDE. GLYCERYL STEARATE. PEG-100 STEARATE. DIMETHICONE. POLYSILICONE-15. AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER. PROPYLENE GLYCOL. CELLULOSE. PARFUM/FRAGRANCE. HYDROXYACETOPHENONE. POLYGLYCERYL-6 BEHENATE. MICA. CI 77891/TITANIUM DIOXIDE. ETHYLHEXYLGLYCERIN. TOCOPHERYL ACETATE. DISODIUM EDTA. CAPRYLIC/CAPRIC TRIGLYCERIDE. BUTYLENE GLYCOL. CHLORPHENESIN. ERYNGIUM MARITIMUM EXTRACT. MARRUBIUM VULGARE EXTRACT. DIPSACUS SYLVESTRIS EXTRACT. PHENETHYL ALCOHOL. FURCELLARIA LUMBRICALIS EXTRACT. SODIUM CITRATE. ARBUTUS UNEDO FRUIT EXTRACT. CITRIC ACID. TOCOPHEROL. CI 15985/YELLOW 6. LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT. MARIS SAL/SEA SALT/SEL MARIN. CI 17200/RED 33. [S4306A*]

Other Information:

SPL UNCLASSIFIED SECTION

  • protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

 Call 1-866-325-2746 Monday-Friday 9am to 6:30pm ET www.clarins.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package(1)Outer Package(1)Inner Package(1)Inner Package(1)

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58668-9621-1CLARINS Multi-Active Jour Niacinamide and Sea Holly Extract Sunscreen SPF 1550 mL in 1 JARCREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58668-9621CLARINS MULTI-ACTIVE JOUR NIACINAMIDE AND SEA HOLLY EXTRACT SUNSCREEN SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [LABORATOIRES CLARINS]2Current NDC, 1 package rows20250409_a43d0d4f-94de-4c4b-a17a-63a819d5d293.zip

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
58668-962158668-9621-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
BETAINE3SCV180C9WIACT
POLYGLYCERYL-6 STEARATEETY9Q81E2TIACT
PENTYLENE GLYCOL50C1307PZGIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
NIACINAMIDE25X51I8RD4IACT
GLYCERYL STEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
DIMETHICONE92RU3N3Y1OIACT
POLYSILICONE-15F8DRP5BB29IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POWDERED CELLULOSESMD1X3XO9MIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
POLYGLYCERYL-6 BEHENATE4T2L7QI313IACT
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
EDETATE DISODIUM7FLD91C86KIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CHLORPHENESINI670DAL4SZIACT
HOREHOUNDK08036XEJVIACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
FURCELLERAN30QS0PF14UIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
ARBUTUS UNEDO FRUITTV3WD0O8JFIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
TOCOPHEROLR0ZB2556P8IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
LAPSANA COMMUNIS FLOWERING TOPT9B77O7PZAIACT
SEA SALT87GE52P74GIACT
D&C RED NO. 339DBA0SBB0LIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
CLARINS Multi-Active Jour Niacinamide and Sea Holly Extract Sunscreen SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELaboratoires Clarinsa43d0d4f-94de-4c4b-a17a-63a819d5d2932025-04-07WarningsExact identifier
ndc (package): 58668-9621-1
ndc (product): 58668-9621
ndc11 (package): 58668962101
spl id: 322e0491-63a1-5577-e063-6294a90a18ed
spl set id: a43d0d4f-94de-4c4b-a17a-63a819d5d293

Reported adverse events (FAERS/openFDA)#

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