FDA.reportPublic FDA data

Avene Mineral Sunscreen Face and Body

Product NDC
64760-780
11-digit product format
647600780
Labeler code
64760
Product ID
64760-780_26442e95-2a13-2003-e063-6394a90a3f62
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
Pierre Fabre USA Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-05-17
Substance
ZINC OXIDE
Active strength
120 mg/120mg
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Avene Mineral Sunscreen Face and Body
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE120 mg/120mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fb5b1e94-bed3-8486-e053-6294a90a3a84Available on FDA.report

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

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 119 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Physical DefenseTITANIUM DIOXIDE, ZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER35477ed2-0875-58d5-e063-6294a90a3d5d2025-12-15Exact identifier
application number: M020
Anti Aging Daily ProtectionZINC OXIDELEVERRIER, KAMILA35465f21-8bcd-6e44-e063-6294a90a8e5f2025-12-15Exact identifier
application number: M020
Anti Aging Daily ProtectionZINC OXIDELEVERRIER, KAMILA3546d369-3435-b56a-e063-6294a90a08432025-12-15Exact identifier
application number: M020
Tinted Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDEHELTON SKIN & LASER INSTITUTE35a97770-2db9-99aa-e063-6294a90a459a2025-12-15Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDEHELTON SKIN & LASER INSTITUTE35a9d07d-70e5-5eed-e063-6394a90aebaf2025-12-15Exact identifier
application number: M020
Non-Tinted Sports StickTITANIUM DIOXIDE, ZINC OXIDEHELTON SKIN & LASER INSTITUTE35aa833a-19a1-99e9-e063-6394a90a840f2025-12-15Exact identifier
application number: M020
Tinted Facial PrimerTITANIUM DIOXIDE, ZINC OXIDEBEE NATURALS36c3352e-fa51-19ad-e063-6394a90a591b2025-12-15Exact identifier
application number: M020
Luminous Tinted MoisturizingZINC OXIDESKIN BOSS L.L.C.35a8ae26-82eb-e4ca-e063-6394a90a00222025-12-15Exact identifier
application number: M020
Restore Tinted MoisturizingZINC OXIDESKIN BOSS L.L.C.35a8e92e-ced2-fdcd-e063-6294a90acedc2025-12-15Exact identifier
application number: M020
Velvet Tinted Moisturizing Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN BOSS L.L.C.35a871dc-a707-9963-e063-6294a90a43962025-12-15Exact identifier
application number: M020
Velvet NT Moisturizing Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN BOSS L.L.C.35a8508d-7069-c2d6-e063-6394a90a62192025-12-15Exact identifier
application number: M020
Daily Skin Protection Sunscreen NTZINC OXIDESKINPLUSBYOROYO LLC35a94d6f-9b1c-1b26-e063-6394a90abe652025-12-15Exact identifier
application number: M020
Daily Skin Protection Sunscreen NTZINC OXIDESKINPLUSBYOROYO LLC35a9a6ed-c446-c90c-e063-6294a90aaa742025-12-15Exact identifier
application number: M020
Daily Skin Protection Sunscreen TintedZINC OXIDESKINPLUSBYOROYO LLC35a9ecd7-b416-0aab-e063-6294a90a323d2025-12-15Exact identifier
application number: M020
Proper Protection Plus Primer NTTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC3596fe93-836b-4f8e-e063-6294a90a674a2025-12-15Exact identifier
application number: M020
Proper Protection Plus Primer TintedTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC359723bb-6152-9566-e063-6294a90a59e02025-12-15Exact identifier
application number: M020
Daily Skin Protection Sunscreen TintedZINC OXIDESKINPLUSBYOROYO LLC35aa194a-9a2e-2b5f-e063-6294a90a98772025-12-15Exact identifier
application number: M020
Proper Protection Plus Primer NTTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC3596cd73-0811-32bc-e063-6394a90ad1322025-12-15Exact identifier
application number: M020
Proper Protection Plus Primer TintedTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC359782d7-6601-7d96-e063-6394a90af9dc2025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY RIKI LLC37f1b692-0b80-0536-e063-6294a90ae8632025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64760-780-01647600780011 TUBE in 1 CARTON (64760-780-01) / 120 mg in 1 TUBE1 tube2023-06-26NoNoCurrent