FDA.reportPublic FDA data

Alumier MD Sheer Hydration

Product NDC
69473-021
Requested package NDC
69473-021-01
11-digit product format
694730021
Labeler code
69473
Product ID
69473-021_2868ac64-d5be-7387-e063-6294a90aca92
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Alumier Labs
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-04
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
62.8; 70 mg/mL; mg/mL
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
Alumier MD Sheer Hydration
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE62.8 mg/mL
TITANIUM DIOXIDE70 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2874e531-d647-339c-e063-6394a90ac86fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69473-021-01Alumier MD Sheer Hydration1 in 1 CARTONLOTION11
69473-021-01Alumier MD Sheer Hydration60 mL in 1 TUBELOTION601
69473-021-02Alumier MD Sheer Hydration15 mL in 1 TUBELOTION151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69473-021ALUMIER MD SHEER HYDRATION (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ALUMIER LABS]1Current NDC, 3 package rows20241208_2874e531-d647-339c-e063-6394a90ac86f.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 152 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BINDA Face and Body Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED386f5013-430c-e07f-e063-6394a90a32a82025-12-04WarningsExact identifier
application number: M020
Poolside Not Your Babys Oil. SPF 30 sunscreen body oil.HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452bcb25-848c-e8a7-e063-6394a90ace0f2025-12-04WarningsExact identifier
application number: M020
Sugargirl Glowy face screen sunbeam shimmer sunscreen for the face SPF 30HOMOSALATE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452bd1d2-6a9f-f5e8-e063-6394a90ac9e32025-12-04WarningsExact identifier
application number: M020
Poolside Butter SCREEN SPF 30 sunscreen ButterHOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452bd24d-8654-e6c0-e063-6394a90a0aea2025-12-04WarningsExact identifier
application number: M020
Poolside Glow Butter Screen SPF 30 Shimmer sunscreen ButterHOMOSALATE , OCTOCRYLENE, OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452bd69e-02c7-fcbd-e063-6394a90ae59b2025-12-04WarningsExact identifier
application number: M020
Softlips CherryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companybececc42-1321-430a-80ef-438060fdcc862025-12-04WarningsExact identifier
application number: M020
ATTITUDE Sunly Lip Balm SPF 15 WatermelonZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450d038b-3f99-add8-e063-6294a90aee9a2025-12-03WarningsExact identifier
application number: M020
Natrience Broad Spectrum SPF 30SKIN SHIELDSisel International, LLC1989370f-68a6-6f22-e063-6394a90aacaf2025-12-03Boxed warning, WarningsExact identifier
application number: M020
ATTITUDE Super leaves Lip Balm SPF 15 CoconutZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450d8fd0-20ad-1920-e063-6394a90a72712025-12-03WarningsExact identifier
application number: M020
ATTITUDE Super leaves Lip Balm SPF 15 ExoticZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450db2bb-1788-efc2-e063-6294a90a13c02025-12-03WarningsExact identifier
application number: M020
ATTITUDE Super leaves Lip Balm SPF 15 WatermelonZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450dcc02-8bcb-6c07-e063-6394a90a5df42025-12-03WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral Sunscreen Face Stick SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44acf513-ffe6-888c-e063-6394a90a9c5c2025-12-03WarningsExact identifier
application number: M020
ATTITUDE Sunly Baby Mineral Sunscreen Face Stick SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450e52a9-5a6b-112f-e063-6394a90af7ca2025-12-03WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Face Stick SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450e6eb7-f49e-296e-e063-6294a90a05a42025-12-03WarningsExact identifier
application number: M020
Attitude - Leaves Bar - Lip Balm - SPF 15 - MangoZINC OXIDE9055-7588 Qubec Inc. DBA Attitude359a7ebf-46a6-4e99-b43c-f585e9bc08d92025-12-03WarningsExact identifier
application number: M020
ATTITUDE Sunly Lip balm Unscented SPF 15ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d95a2b7-288d-7b29-e063-6294a90ae46b2025-12-03WarningsExact identifier
application number: M020
Attitude - Lip Balm - SPF 15 - CoconutZINC OXIDEAttitude DBA 9055-7588 Qubec Inc.068af2ec-a666-45bf-b0e0-89d1b93dedf12025-12-03WarningsExact identifier
application number: M020
Cancer Council Invisible Fluid SPF50 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVitality US Co.1629b02b-e9f3-0593-e063-6294a90a9aa52025-12-03WarningsExact identifier
application number: M020
PRO-TECT SPORTS SUNSCREENMERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONEBio-Medical & Pharmaceutical Manufacturing Corporation16994959-cade-06de-e054-00144ff88e882025-12-03WarningsExact identifier
application number: M020
PRO-TECT SPORTS SUNSCREENMERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONEBio-Medical & Pharmaceutical Manufacturing Corporation66bb06fb-33d2-4b57-a65f-66bcd187c6272025-12-03WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69473-021-01694730021011 TUBE in 1 CARTON (69473-021-01) / 60 mL in 1 TUBE1 tube2024-12-04NoNoCurrent