Eau Thermale Avene Hydrating Sunscreen Balm SPF 50 Plus

Manufacturer
Pierre Fabre Dermo-Cosmetique USA, Inc.
Effective date
2019-09-10
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 00:12:48

Label at a glance#

ProductEau Thermale Avene Hydrating Sunscreen Balm SPF 50 Plus
Active ingredientOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC 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

Apply liberally 15 minutes before sun exposure Reapply: after 80 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,...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 6%

Octocrylene 6%

Titanium Dioxide 1.5%

Zinc Oxide 3%

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


OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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
  • Reapply:
    • after 80 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. - 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

Shea Butter Ethyl Esters, Ceresin, Butyloctyl Salicylate, Hydrogenated Polydecene, Hydrogenated Polyisobutene, Copernicia Cerifera (Carnauba) Wax, Polyethylene, Ethylhexyl Palmitate, Ethyl Macadamiate, Aluminum Starch Octenylsuccinate, Octyldodecanol, Lavandula Angustifolia (Lavender) Extract, Water, Glycerin, Silica, Kaolin, Sorbitan Sesquioleate, Hyaluronic Acid, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal Display Panel - 7 g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EAU THERMALE

Avene

HIGH PROTECTION
HAUTE PROTECTION

Broad spectrum SPF 50+

Anti-oxidant

Water resistant

(80 minutes)

50+ UVA/UVB

Hydrating Sunscreen Balm

for sensitive areas

For sensitive skin − Peaux sensibles

PARIS

NET WT. 0.25 OZ. (7 g)

Eau Thermale Avene Hydrating Sunscreen Balm SPF 50 Plus
Eau Thermale Avene Hydrating Sunscreen Balm SPF 50 Plus

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67015-083567015-0835-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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
92358453-4070-5b9c-e053-2a95a90ac52477353294-abd3-4c3b-85f3-2d6cdefcc0862019-09-10WarningsExact identifier
spl id: 92358453-4070-5b9c-e053-2a95a90ac524
spl set id: 77353294-abd3-4c3b-85f3-2d6cdefcc086

Reported adverse events (FAERS/openFDA)#

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