FDA.reportPublic FDA data

Avene Mineral Sunscreen Stick SPF 50

Manufacturer
Pierre Fabre USA Inc.
Effective date
2024-03-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:10:27

Label at a glance#

ProductAvene Mineral Sunscreen Stick SPF 50
Active ingredientZINC OXIDE
Label structure13 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

Adults and children 6 months and older: • Apply generously 15 minutes before sun exposure • Reapply: • at least every 2 hours • after 80 minutes of swimming or sweating • immediately after towel drying • Children under 6 months of age: Ask a doctor • 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 bro...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 12%

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 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 swallowed, call a poison control center or get medical help right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 months and older:

• Apply generously 15 minutes before sun exposure

• Reapply:

• at least every 2 hours

• after 80 minutes of swimming or sweating

• immediately after towel drying

• Children under 6 months of age: Ask a doctor

• 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 value 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.

Other Information

SPL UNCLASSIFIED SECTION

• Protect this product in this container from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Seed Wax, C12-15 Alkyl Benzoate, Jojoba Esters, Octyldodecyl Neopentanoate, Shea Butter Ethyl Esters, Tridecyl Salicylate, Euphorbia Cerifera (Candelilla) Wax, Methylpropanediol, Silica, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Allantoin, Caprylyl Glycol, Lecithin, Phenylpropanol, Tocopherol.

Questions?

OTC - QUESTIONS SECTION

1-866-41-AVENE (28363)

1-877-441-2011 (CAN)

Box 337115

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box 337115Box 337115

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64760-784-01Avene Mineral Sunscreen Stick SPF 501 in 1 CARTONSTICK11
64760-784-01Avene Mineral Sunscreen Stick SPF 5015 g in 1 TUBESTICK151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64760-784AVENE MINERAL SUNSCREEN STICK SPF 50 (ZINC OXIDE) STICK [PIERRE FABRE USA INC.]1Current NDC, 2 package rows20240402_1368482f-3a72-ffa9-e063-6394a90a603e.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64760-78464760-784-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
PHENYLPROPANOL0F897O3O4MIACT
ZINC OXIDESOI2LOH54ZACTIB
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
TOCOPHEROLR0ZB2556P8IACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
SHEA BUTTER ETHYL ESTERSV2CI786FPGIACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
CANDELILLA WAXWL0328HX19IACT
METHYLPROPANEDIOLN8F53B3R4RIACT
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE687U3PEB2YIACT
ALLANTOIN344S277G0ZIACT

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
Avene Mineral Sunscreen Stick SPF 50ZINC OXIDEPierre Fabre USA Inc.1368482f-3a72-ffa9-e063-6394a90a603e2024-03-11WarningsExact identifier
ndc (package): 64760-784-01
ndc (product): 64760-784
ndc11 (package): 64760078401
spl id: 1368482f-3a73-ffa9-e063-6394a90a603e
spl set id: 1368482f-3a72-ffa9-e063-6394a90a603e

Reported adverse events (FAERS/openFDA)#

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