FDA.reportPublic FDA data

AVOBENZONE, HOMOSALATE, OCTOCRYLENE

Manufacturer
Laboratoires Clarins
Effective date
2023-12-08
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:03:47

Label at a glance#

ProductCLARINS - EXTRA-FIRMING JOUR SPF 15 - Wrinkle, Firming Day all skin types - Broad Spectrum SPF 15 Sunscreen
Active ingredientAVOBENZONE, HOMOSALATE, 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 • Spending time in the sun in creases 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-...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

AVOBENZONE 3%  HOMOSALATE 9%  OCTOCRYLENE 6.5%

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 me dical 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

• Spending time in the sun in creases 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 sun screen if swimming or sweating Sun Protection Measures.



Inactive ingredients:

INACTIVE INGREDIENT SECTION

AQUA/WATER/EAU . GLYCERIN . BUTYLOCTYL SALICYLATE . BUTYROSPERMUM PARKII (SHEA) BUTTER . DIMETHICONE . C12-15 ALKYL BENZOATE . CETEARYL ALCOHOL . METHYL METHACRYLATE CROSSPOLYMER . POTASSIUM CETYL PHOSPHATE . PARFUM/FRAGRANCE . CETEARYL GLUCOSIDE . DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER . PHENOXYETHANOL . BUTYLENE GLYCOL . ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER . CAPRYLYL GLYCOL . TROMETHAMINE . AVENA SATIVA (OAT) KERNEL EXTRACT . DISODIUM EDTA . TOCOPHERYL ACETATE . XANTHAN GUM . DIMETHICONOL . TOCOPHEROL . ANIGOZANTHOS FLAVIDUS EXTRACT . CAPRYLIC/CAPRIC TRIGLYCERIDE . BETAINE . SILICA . SORBITOL . DIOSPYROS MESPILIFORMIS LEAF EXTRACT . MALTODEXTRIN . SANICULA EUROPAEA EXTRACT . SODIUM BENZOATE . KALANCHOE PINNATA LEAF EXTRACT . BALANITES ROXBURGHII SEED OIL . MITRACARPUS SCABER EXTRACT . CITRIC ACID . MALPIGHIA EMARGINATA (ACEROLA) SEED EXTRACT . LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT . FURCELLARIA LUMBRICALIS EXTRACT . CI 15985/YELLOW 6 . POTASSIUM SORBATE . MARIS SAL/SEA SALT/SEL MARIN. [S3095A]

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer LabelOuter LabelInner LabelInner Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58668-9918-1CLARINS - EXTRA-FIRMING JOUR SPF 15 - Wrinkle, Firming Day all skin types - Broad Spectrum SPF 15 Sunscreen50 mL in 1 JARCREAM5010
58668-9918-1CLARINS - EXTRA-FIRMING JOUR SPF 15 - Wrinkle, Firming Day all skin types - Broad Spectrum SPF 15 Sunscreen1 in 1 CARTONCREAM110
58668-9918-2CLARINS - EXTRA-FIRMING JOUR SPF 15 - Wrinkle, Firming Day all skin types - Broad Spectrum SPF 15 Sunscreen1 in 1 CARTONCREAM110
58668-9918-2CLARINS - EXTRA-FIRMING JOUR SPF 15 - Wrinkle, Firming Day all skin types - Broad Spectrum SPF 15 Sunscreen50 mL in 1 JARCREAM5010
58668-9918-3CLARINS - EXTRA-FIRMING JOUR SPF 15 - Wrinkle, Firming Day all skin types - Broad Spectrum SPF 15 Sunscreen1 in 1 CARTONCREAM110
58668-9918-3CLARINS - EXTRA-FIRMING JOUR SPF 15 - Wrinkle, Firming Day all skin types - Broad Spectrum SPF 15 Sunscreen15 mL in 1 TUBECREAM1510
58668-9918-4CLARINS - EXTRA-FIRMING JOUR SPF 15 - Wrinkle, Firming Day all skin types - Broad Spectrum SPF 15 Sunscreen5 mL in 1 TUBECREAM510
58668-9918-4CLARINS - EXTRA-FIRMING JOUR SPF 15 - Wrinkle, Firming Day all skin types - Broad Spectrum SPF 15 Sunscreen1 in 1 CARTONCREAM110
58668-9918-5CLARINS - EXTRA-FIRMING JOUR SPF 15 - Wrinkle, Firming Day all skin types - Broad Spectrum SPF 15 Sunscreen1 in 1 CARTONCREAM110
58668-9918-5CLARINS - EXTRA-FIRMING JOUR SPF 15 - Wrinkle, Firming Day all skin types - Broad Spectrum SPF 15 Sunscreen2 mL in 1 BAGCREAM210
58668-9918-6CLARINS - EXTRA-FIRMING JOUR SPF 15 - Wrinkle, Firming Day all skin types - Broad Spectrum SPF 15 Sunscreen1 in 1 CARTONCREAM110
58668-9918-6CLARINS - EXTRA-FIRMING JOUR SPF 15 - Wrinkle, Firming Day all skin types - Broad Spectrum SPF 15 Sunscreen2 mL in 1 BAGCREAM210

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58668-9918CLARINS - EXTRA-FIRMING JOUR SPF 15 - WRINKLE, FIRMING DAY ALL SKIN TYPES - BROAD SPECTRUM SPF 15 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE) CREAM [LABORATOIRES CLARINS]10Current NDC, Legacy NDC, 12 package rows20231210_ae34fdcb-d372-435f-bf7c-075ea554b2fe.zip

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58668-991858668-9918-1, 58668-9918-2, 58668-9918-3, 58668-9918-4, 58668-9918-5, 58668-9918-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
SHEA BUTTERK49155WL9YIACT
DIMETHICONE92RU3N3Y1OIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CAPRYLYL GLYCOL00YIU5438UIACT
TROMETHAMINE023C2WHX2VIACT
OATZ6J799EAJKIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
XANTHAN GUMTTV12P4NEEIACT
TOCOPHEROLR0ZB2556P8IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
BETAINE3SCV180C9WIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SORBITOL506T60A25RIACT
DIOSPYROS MESPILIFORMIS LEAF0R6X2JX6J1IACT
MALTODEXTRIN7CVR7L4A2DIACT
SODIUM BENZOATEOJ245FE5EUIACT
KALANCHOE PINNATA LEAF3R963LO08TIACT
BALANITES ROXBURGHII SEED OILCZ67V4ZW0IIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
MALPIGHIA EMARGINATA SEED1X7L93686MIACT
LAPSANA COMMUNIS FLOWERING TOPT9B77O7PZAIACT
FURCELLERAN30QS0PF14UIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SEA SALT87GE52P74GIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
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 - EXTRA-FIRMING JOUR SPF 15 - Wrinkle, Firming Day all skin types - Broad Spectrum SPF 15 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENELaboratoires Clarinsae34fdcb-d372-435f-bf7c-075ea554b2fe2023-12-08WarningsExact identifier
ndc (package): 58668-9918-2
ndc (package): 58668-9918-6
ndc (package): 58668-9918-5
ndc (package): 58668-9918-4
ndc (package): 58668-9918-3
ndc (package): 58668-9918-1
ndc (product): 58668-9918
ndc11 (package): 58668991806
ndc11 (package): 58668991801
ndc11 (package): 58668991803
ndc11 (package): 58668991805
ndc11 (package): 58668991804
ndc11 (package): 58668991802
spl id: 0c0b03d9-8b24-12d2-e063-6394a90a92c4
spl set id: ae34fdcb-d372-435f-bf7c-075ea554b2fe

Reported adverse events (FAERS/openFDA)#

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