FDA.reportPublic FDA data

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 299 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MELAN SPF-30 Antioxidant Body Mist SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMELAN INC.66b7c899-46fd-41a6-9a96-ebbf2b68ea252024-05-02WarningsExact identifier
application number: M020
No7 Restore and Renew Face and Neck Multi Action Day Cream Sunscreen Broad Spectrum SPF 30AVOBENZONE,OCTISALATE, OCTOCRYLENE.BCM Ltd4ce3fe14-e33d-cbf6-e063-6294a90a42fe2024-04-30WarningsExact identifier
application number: M020
bareMinerals BAREPRO 24HR Wear Skin-Perfecting Matte Liquid Foundation Fair 10 NeutralZINC OXIDEOrveon Global US LLC1740393b-f8a3-475b-e063-6394a90a6fa82024-04-29WarningsExact identifier
application number: M020
SUMMER GELEE SPF-30HOMOSALATE, OCTISALATE, OCTOCRYLENESUMMER GELEE LLCbc85db65-2acc-4b39-9189-f8916c487b612024-04-27WarningsExact identifier
application number: M020
SUMMER GELEE SPF-4HOMOSALATE, OCTISALATESUMMER GELEE LLCc9ec81ad-0478-4026-bc6c-5582eb012b8d2024-04-27WarningsExact identifier
application number: M020
Natural Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESarati International, Inc.16ef922d-78d1-1e70-e063-6394a90a3bbf2024-04-25WarningsExact identifier
application number: M020
PRISMA PROTECT SPF30OCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONEDermalogica, LLC.e0e6d779-c491-43ed-acc9-274d1b60c1ff2024-04-25WarningsExact identifier
application number: M020
Degil Sun SPF 30 SunscreenHOMOSALATE, OCTISALATE, OXYBENZONE,AVOBENZONE, OCTOCRYLENEDegil Safety Products (1989) Inc16d8d1d0-e531-2a64-e063-6394a90a5b9c2024-04-24WarningsExact identifier
application number: M020
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 AlabasterTITANIUM DIOXIDEChantecaille Beaute Ince1c562b8-76c0-4c6e-9276-900784c8639e2024-04-24WarningsExact identifier
application number: M020
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 WheatTITANIUM DIOXIDEChantecaille Beaute Inc89f19f7a-60e3-4080-a49a-a4eb3e6c27de2024-04-24WarningsExact identifier
application number: M020
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 AuraTITANIUM DIOXIDEChantecaille Beaute Incde441a6c-55e3-4b11-afb3-d7db3c6971f02024-04-24WarningsExact identifier
application number: M020
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 BlissTITANIUM DIOXIDEChantecaille Beaute Inc16d9e226-7694-922a-e063-6394a90aea852024-04-24WarningsExact identifier
application number: M020
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 GlowTITANIUM DIOXIDEChantecaille Beaute Incf868fe4f-4c10-4f0f-9f1d-008f067744082024-04-24WarningsExact identifier
application number: M020
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 NudeTITANIUM DIOXIDEChantecaille Beaute Inccb8feddc-ae98-42ea-ad1e-583dcacfa5d92024-04-24WarningsExact identifier
application number: M020
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 OpalineTITANIUM DIOXIDEChantecaille Beaute Inc1c918b4b-763b-48bf-9ae3-661eabafee162024-04-24WarningsExact identifier
application number: M020
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 TanTITANIUM DIOXIDEChantecaille Beaute Incfdf05545-5a21-4238-b0d3-e3fcdfe866ff2024-04-24WarningsExact identifier
application number: M020
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 TopazTITANIUM DIOXIDEChantecaille Beaute Inc2012f671-7889-4e29-b70f-215cbc9dbdc72024-04-24WarningsExact identifier
application number: M020
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 VanillaTITANIUM DIOXIDEChantecaille Beaute Inc7133c47d-ed1c-43e9-8cdf-42f7b2f215f52024-04-24WarningsExact identifier
application number: M020
Eco Lips PlantPod Sunscreen Lip Balm Vanilla SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEEco Lips. Inc.fd8edc49-762a-b718-e053-6394a90a65f52024-04-23WarningsExact identifier
application number: M020
SKINPERFECT PRIMER SPF30ZINC OXIDEDermalogica, LLC.692f9cda-eb6c-431f-a575-3778c6e12e3b2024-04-23WarningsExact 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