Avene Solaire UV Tinted Mineral Sunscreen

Manufacturer
Pierre Fabre USA Inc.
Effective date
2024-01-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:07:38

Label at a glance#

ProductAvene Solaire UV Tinted 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 40 minutes of swimming or sweating • immediately after towel drying • 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, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measur...

Storage and handling

• Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12%

Purpose

OTC - PURPOSE SECTION

Sunscreen

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

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

OTC - STOP USE SECTION

if 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

INDICATIONS & USAGE SECTION

• shake well before use • apply liberally 15 minutes before sun exposure • reapply: • after 40 minutes of swimming or sweating • immediately after towel drying • 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, 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

STORAGE AND HANDLING SECTION

• Protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, C12-15 ALKYL BENZOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, PROPANEDIOL, JOJOBA ESTERS, TRIDECYL SALICYLATE, METHYLHEPTYL ISOSTEARATE, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, NIACINAMIDE, NYLON-12, METHYLPROPANEDIOL, COCO-CAPRYLATE, IRON OXIDES, SILICA, AVENE THERMAL SPRING WATER, 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, HYDROGENATED LECITHIN,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+

UVA/UVB

Broad Spectrum SPF 50+

Solaire UV

Mineral Multi-Defense

Tinted Sunscreen Fluid

Fragrance-Free • Oil-Free

Water Resistant (40-Minute)

Sheer, Natural Finish

Sensitive Skin

50 ml/1.7 FL. OZ.

Pierre Fabre

Dermo-Cosmetique

Laboratoires Dermatologiques Avène
45, place Abel-Gance
92100 Boulogne - Paris - France
Les Cauquillous - 81500 Lavaur - France
Distributed by:
Pierre Fabre USA Inc
Parsippany, NJ 07054

labellabel

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64760-725AVENE SOLAIRE UV TINTED MINERAL SUNSCREEN SPF 50 PLUS (ZINC OXIDE) LOTION [PIERRE FABRE USA INC.]3Legacy NDC20240120_c28682af-b0ef-5148-e053-2995a90abc67.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64760-72564760-725-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

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
0f4e4e7d-4529-5375-e063-6394a90a5408c28682af-b0ef-5148-e053-2995a90abc672024-01-19WarningsExact identifier
spl id: 0f4e4e7d-4529-5375-e063-6394a90a5408
spl set id: c28682af-b0ef-5148-e053-2995a90abc67

Reported adverse events (FAERS/openFDA)#

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