Avene Mineral Sunscreen Stick SPF 50

Product NDC
64760-784
11-digit product format
647600784
Labeler code
64760
Product ID
64760-784_1368482f-3a73-ffa9-e063-6394a90a603e
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc oxide
Dosage form
STICK
Route
TOPICAL
Labeler
Pierre Fabre USA Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-01
Substance
ZINC OXIDE
Active strength
12 g/100g
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 Stick SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE12 g/100g

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
1368482f-3a72-ffa9-e063-6394a90a603eAvailable on FDA.report

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

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 262 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EGF FGF DNA UV SHIELDETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATEDermaesthetics Inc.13e2630d-9915-4287-91fd-deb6721501312024-12-04WarningsExact identifier
application number: M020
SUNSCREEN 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.e98c3b64-edcb-16c7-e053-2a95a90a8a0e2024-12-04WarningsExact identifier
application number: M020
Sun ,Bug Handsfree 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.f8f29aec-935f-e828-e053-6394a90a570a2024-12-04WarningsExact identifier
application number: M020
sunscreen 01AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.e9e3ecc1-3f13-1d0e-e053-2a95a90ac7f82024-12-04WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB No 13ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.95846b5e-5b72-26bc-e053-2a95a90ae0f72024-12-04WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB No 21ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.9585d3d2-806c-36e3-e053-2a95a90a28fa2024-12-04WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB SPF42 No21OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDEAble C&C Co., Ltd.3d196cf3-eddd-21d7-e054-00144ff88e882024-12-04WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB No 23ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.6a81522e-f4d9-4013-8563-f50f01ff63262024-12-04WarningsExact identifier
application number: M020
Milani Prime Protect SPF 30 Face PrimerAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONEThe Milani Group, Inc.d557d554-5161-482c-bd78-7721c7dc9a6e2024-12-04WarningsExact identifier
application number: M020
Pipette Diaper RashZINC OXIDEAmyris, Incef5ea6f5-0126-47de-9bee-9070c5f6112b2024-12-04WarningsExact identifier
application number: M020
Elta MD Skincare UV Stick Broad Spectrum SPF50ZINC OXIDECP Skin Health Group, Inc81a889b8-0719-40c9-b8d4-d9220747ce492024-12-04WarningsExact identifier
application number: M020
Bright-eyed 100% mineral Eye Cream Broad Spectrum Sunscreen SPF 40ZINC OXIDESupergoop, LLC971ac413-5e69-7553-e053-2995a90a41682024-12-04WarningsExact identifier
application number: M020
PLAY Antioxidant Body Mist SPF 50 With Vitamin CAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC9c5c0608-3f42-6640-e053-2a95a90a50862024-12-04WarningsExact identifier
application number: M020
LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 PERLA 100TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S Ae4bb5a32-c5dc-86d5-e053-2a95a90a49382024-12-04WarningsExact identifier
application number: M020
Burts Bees Firming Day SPF30ZINC OXIDEBurts Beesf028ffea-184b-46db-9e48-dab4a535bf002024-12-03WarningsExact identifier
application number: M020
Burts Bees Calming Day SPF30ZINC OXIDEBurts Beese406e6ba-fa6d-452d-bc29-404e2f8fcf3e2024-12-03WarningsExact identifier
application number: M020
Alumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen AmberZINC OXIDE, TITANIUM DIOXIDEAlumier Labsba864a08-e66d-d286-e053-2995a90a18542024-12-03WarningsExact identifier
application number: M020
Alumier MD Sheer HydrationTITANIUM DIOXIDE, ZINC OXIDEAlumier Labs2874e531-d647-339c-e063-6394a90ac86f2024-12-03WarningsExact identifier
application number: M020
REEF SAFE Unscented SPF Mineral Sunscreen 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.286965aa-0961-0141-e063-6394a90aa3f02024-12-03WarningsExact identifier
application number: M020
Alumier MD Sheer Hydration Tinted Moisturizing SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa951ebe7-7786-38ef-e053-2995a90a70e32024-12-03WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64760-784-01647600784011 TUBE in 1 CARTON (64760-784-01) / 15 g in 1 TUBE1 tube2024-04-01NoNoCurrent