FDA.reportPublic FDA data

Avene Mineral Sunscreen Face & Body Lotion SPF 50

Manufacturer
Pierre Fabre USA Inc.
Effective date
2024-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:35:16

Label at a glance#

ProductAvene Mineral Sunscreen Face and Body
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply generously 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating. immediately after towel drying. at least every 2 hours. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in te 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 su...

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Sunscreen

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12%

Uses

INDICATIONS & USAGE SECTION

helps prevent sunburn.

if used as directed with other sun protection measures (see Directions), decreased 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

DOSAGE & ADMINISTRATION SECTION

Apply generously 15 minutes before sun exposure.

Reapply:

  • after 80 minutes of swimming or sweating.
  • immediately after towel drying.
  • at least every 2 hours.
  • children under 6 months of age: Ask a doctor.

Sun Protection Measures. Spending time in te 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

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allantoin, avene thermal spring water (avene aqua), bisabolol, C12-C15 alkyl benzoate, caprylic/capric triglyceride, caprylyl glycol, coco-caprylate, glycerin, glyceryl behenate, glyceryl dibehenate, glyceryl stearate, isoamyl laurate, lecithin, methylpropanediol, neopentyl glycol diheptanoate, phenylpropanol, polyester-7, polyglyceryl-3 polricinoleate, polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate, silica, sodium chloride, tocopherol, tocopheryl acetate, tribehenin, tridecyl salic

Questions?

OTC - QUESTIONS SECTION

1-866-41-AVENE (28363)

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EAU THERMALE

AVENE

LABORATORIE DERMATOLOGIQUE

MINERAL SUNSCREEN

SPRF 50 UVA-UVB

BROAD SPECTRUM SPF50

FACE & BODY LOTION

FOR SENSITIVE SKIN

CHILDREN & ADULTS

LIGHTWEIGHT TEXTURE

FAST-ABSORPTION

WATER-RESISTANT (80 MINUTES)

125ML 4.2 FL.OZ.

Avene Face Body LotionAvene Face Body Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64760-780-01Avene Mineral Sunscreen Face and Body120 mg in 1 TUBELOTION1202
64760-780-01Avene Mineral Sunscreen Face and Body1 in 1 CARTONLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64760-780AVENE MINERAL SUNSCREEN FACE AND BODY (ZINC OXIDE) LOTION [PIERRE FABRE USA INC.]2Current NDC, 2 package rows20241108_fb5b1e94-bed3-8486-e053-6294a90a3a84.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64760-78064760-780-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOAMYL LAURATEM1SLX00M3MIACT
COCO-CAPRYLATE4828G836N6IACT
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDEFJ1H6M2JG9IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
ZINC OXIDESOI2LOH54ZACTIB
GLYCERYL DIBEHENATER8WTH25YS2IACT
ALLANTOIN344S277G0ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
POLYESTER-70841698D2FIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
GLYCERYL BEHENATE/EICOSADIOATE73CJJ317SRIACT
PHENYLPROPANOL0F897O3O4MIACT
TOCOPHEROLR0ZB2556P8IACT
GLYCERINPDC6A3C0OXIACT
SODIUM CHLORIDE451W47IQ8XIACT
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE687U3PEB2YIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
CAPRYLYL GLYCOL00YIU5438UIACT
LEVOMENOL24WE03BX2TIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TRIBEHENIN8OC9U7TQZ0IACT

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 Face and BodyZINC OXIDEPierre Fabre USA Inc.fb5b1e94-bed3-8486-e053-6294a90a3a842024-11-06WarningsExact identifier
ndc (package): 64760-780-01
ndc (product): 64760-780
ndc11 (package): 64760078001
spl id: 26442e95-2a13-2003-e063-6394a90a3f62
spl set id: fb5b1e94-bed3-8486-e053-6294a90a3a84

Reported adverse events (FAERS/openFDA)#

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