FDA.reportPublic FDA data

Avene Solaire UV Mineral Sunscreen

Manufacturer
Pierre Fabre USA Inc.
Effective date
2024-01-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:07:38

Label at a glance#

ProductAvene Solaire UV Mineral Sunscreen SPF 50 PLUS
Active ingredientZINC OXIDE
Label structure9 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

Shake well before use. Apply liberally 15 minutes before sun exposure. Reapply. After 80 minutes of swimming or sweating. Immediately after towel dry. At least every 2 hours. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk of skin cancer and early skin gaining. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF...

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Sunscreen

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12%

Uses

DOSAGE & ADMINISTRATION 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 on damaged or broken skin.

OTC - DO NOT USE SECTION

When using this product, keep out of eyes. Rinse with water to remove.

OTC - WHEN USING SECTION

Stop use and ask a doctor if rash occurs.

OTC - STOP USE SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

INDICATIONS & USAGE SECTION

Shake well before use.

Apply liberally 15 minutes before sun exposure.

Reapply.

After 80 minutes of swimming or sweating.

Immediately after towel dry.

At least every 2 hours.

Sun Protection Measures.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk of skin cancer and early skin gaining. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

Limit time in the sun, especially from 10 a.m to 2 p.m.

Wear long-sleeve shirts, pants, hats, and sunglasses.

Children under 6 months: Ask a doctor.

Other information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

AVÈNE THERMAL SPRING WATER, C12-15 ALKYL BENZOATE,
CAPRYLIC/CAPRIC TRIGLYCERIDE, PROPANEDIOL, JOJOBA ESTERS,
TRIDECYL SALICYLATE, METHYLHEPTYL ISOSTEARATE, POLYGLYCERYL-4
DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, NYLON-12,
NIACINAMIDE, METHYLPROPANEDIOL, COCO-CAPRYLATE, SILICA,
SODIUM CHLORIDE, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE,
CAPRYLYL GLYCOL, BISABOLOL, ALLANTOIN, ORYZA SATIVA (RICE)
BRAN EXTRACT, LECITHIN, PHENYLPROPANOL, HELIANTHUS
ANNUUS (SUNFLOWER) EXTRACT, TOCOPHEROL, ROSMARINUS
OFFICINALIS (ROSEMARY) LEAF EXTRACT, TETRASODIUM
GLUTAMATE DIACETATE, ISOSTEARIC ACID, 1,2-HEXANEDIOL,
SODIUM HYDROXIDE

Questions or comments?

OTC - QUESTIONS SECTION

visit www.aveneusa.com or call toll-free 1-866-41-AVENE (28363)

Principal Display Panel - 50 mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EAU THERMALE

Avene

SPF 50+

Broad Spectrum

Solaire UV

Mineral Multi-Defense

Sunscreen Fluid

Fragrance-Free

Oil-Free

40-Minute Water Resistance

Sheer, Non-Whitening

For Sensitive Skin

50 ml/1.7 FL. OZ.

Avene Multi Defense Sunscreen Fluid Carton 50mlAvene Multi Defense Sunscreen Fluid Carton 50ml

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64760-724-012023-04-04C16284748780-1f386c649-fa96-0266-e053-dadaa90a7c1aAvene Solaire UV Mineral Sunscreen SPF 50 PLUS
64760-724-012023-01-30C16284748780-1f386c649-fa96-0266-e053-dadaa90a7c1aAvene Solaire UV Mineral Sunscreen SPF 50 PLUS

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64760-724AVENE SOLAIRE UV MINERAL SUNSCREEN SPF 50 PLUS (ZINC OXIDE) LOTION [PIERRE FABRE USA INC.]4Legacy NDC20240120_c2389089-bdc4-1ce5-e053-2995a90ac612.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64760-72464760-724-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
ROSEMARY OIL8LGU7VM393IACT
LEVOMENOL24WE03BX2TIACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
NIACINAMIDE25X51I8RD4IACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
PROPANEDIOL5965N8W85TIACT
SODIUM CHLORIDE451W47IQ8XIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
CAPRYLYL GLYCOL00YIU5438UIACT
ISOSTEARIC ACIDX33R8U0062IACT
SODIUM HYDROXIDE55X04QC32IIACT
JOJOBA OIL724GKU717MIACT
METHYLHEPTYL ISOSTEARATE981F40Q9FFIACT
NYLON-12446U8J075BIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
COCO-CAPRYLATE4828G836N6IACT
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ALLANTOIN344S277G0ZIACT
RICE BRAN OILLZO6K1506AIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
PHENYLPROPANOL0F897O3O4MIACT
HELIANTHUS ANNUUS WHOLE17S27ZT6KRIACT
TOCOPHEROLR0ZB2556P8IACT

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
0f4e1f81-86fc-b473-e063-6294a90ac062c2389089-bdc4-1ce5-e053-2995a90ac6122024-01-19WarningsExact identifier
spl id: 0f4e1f81-86fc-b473-e063-6294a90ac062
spl set id: c2389089-bdc4-1ce5-e053-2995a90ac612

Reported adverse events (FAERS/openFDA)#

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