Titanium Dioxide, Zinc Oxide

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 00:12:54

Label at a glance#

ProductEau Thermale Avene Complexion Correcting Shield Light Mineral Sunscreen SPF 50 Plus
Active ingredientTITANIUM 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 at least every 2 hours Use a water resistant sunscreen if swimming or sweating 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 ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 13.2%

Zinc Oxide 15.6%

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 at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • 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
  • May stain fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Caprylic/Capric Triglyceride, Hydrogenated Polyisobutene, Dimethicone, Butyloctyl Salicylate, Isodecyl Neopentanoate, Polyhydroxystearic Acid, C12‐15 Alkyl Benzoate, Magnesium Aluminum Silicate, Polymethyl Methacrylate, Potassium Cetyl Phosphate, VP/Eicosene Copolymer, Polysorbate 20, Soyethyl Morpholinium Ethosulfate, Iron Oxides, Trimethylsiloxysilicate, Cetearyl Alcohol, Xanthan Gum, Glycerin, Phenoxyethanol, Hydrogenated Lecithin, Stearic Acid, PEG/PPG/Polybutylene Glycol‐8/5/3 Glycerin, Carbomer, Ceramide AP, Ceramide EOP, Ceramide NP, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Tocopherol, Sodium Hyaluronate, Ethylhexylglycerin, Disodium EDTA, Tocopheryl Acetate, Allantoin, Ascorbic Acid

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal Display Panel - 40 mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EAU THERMALE

Avene

HIGH PROTECTION
HAUTE PROTECTION

Broad spectrum SPF 50+

Anti-oxidant

Medium-full coverage

Blur effect

Light

50+ UVA/UVB

Complexion Correcting

Shield

Mineral Sunscreen

FRAGRANCE-FREE • OIL-FREE

For sensitive skin − Peaux sensibles

PARIS

1.35 FL. OZ. (40 mL)

Eau Thermale Avene High Protection Complexion Correcting Shield Light Mineral Sunscreen SPF 50+
Eau Thermale Avene High Protection Complexion Correcting Shield Light Mineral Sunscreen SPF 50+

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67015-083267015-0832-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 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
92354ba5-31a3-7c19-e053-2a95a90a92bcdf4156fb-4599-4e1a-a4ea-5e2e5075b4732019-09-10WarningsExact identifier
spl id: 92354ba5-31a3-7c19-e053-2a95a90a92bc
spl set id: df4156fb-4599-4e1a-a4ea-5e2e5075b473

Reported adverse events (FAERS/openFDA)#

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