FDA.reportPublic FDA data

Alumier MD Sheer Hydration

Product NDC
69473-021
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 12 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Juice Body Mist Sunscreen SPF30 - Cotton Candy Skies PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC568083ff-0da9-7f14-e063-6394a90a43012026-07-13WarningsExact identifier
application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Vanilla Breeze PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC3cc62c97-70c5-17f7-e063-6394a90abe252026-07-13WarningsExact identifier
application number: M020
Norwex Lip Glaze Broad Spectrum SPF 30 RoseZINC OXIDENorwex Usa, Inc.565feded-8e25-e628-e063-6294a90aee482026-07-11WarningsExact identifier
application number: M020
PoutScreen Lip Treatment Lemon MeringueAVOBENZONE, OCTINOXATE, OCTOCRYLENENAKED SUNDAYS PTY LTD563e3ab9-4ee2-279c-e063-6294a90a7cf12026-07-10WarningsExact identifier
application number: M020
INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - ROSY BROWNZINC OXIDECOSMAX USA, CORPORATION5643a73d-757c-702d-e063-6294a90a2c122026-07-10WarningsExact identifier
application number: M020
INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - LATTEZINC OXIDECOSMAX USA, CORPORATION5643d655-e335-5643-e063-6394a90a483a2026-07-10WarningsExact identifier
application number: M020
MUSELY DAYCREAM SPF40ZINC OXIDECOSMAX USA, CORPORATION56443156-3edb-a643-e063-6394a90adf9f2026-07-10WarningsExact identifier
application number: M020
Hello Sun Silky Glow Broad Spectrum SPF40ZINC OXIDECosmax USA, Corporation56445f2d-8e5a-34eb-e063-6294a90ae26e2026-07-10WarningsExact identifier
application number: M020
Hello Kitty Fun Broad Spectrum SPF 40ZINC OXIDECosmax USA Corporation5644854e-18d6-617d-e063-6294a90ab3e72026-07-10WarningsExact identifier
application number: M020
VERSED DAILY SUNSCREEN SPF 50HOMOSALATE, OCTISALATE, AVOBENZONECOSMAX USA, CORP5644ca1e-9032-d3fb-e063-6394a90a961e2026-07-10WarningsExact identifier
application number: M020
Hello Kitty Sunny Days Broad Spectrum SPF 40ZINC OXIDECosmax USA Corporation5644855d-f864-e07b-e063-6394a90a51482026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40ZINC OXIDECOSMAX USA, CORP5644d49f-08b9-e806-e063-6294a90a80f92026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT NEUTRALZINC OXIDECOSMAX USA, CORP564682e5-1051-9936-e063-6394a90abe1d2026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT WRMZINC OXIDECOSMAX USA, CORP5646e069-5461-12c5-e063-6294a90abacb2026-07-10WarningsExact identifier
application number: M020
Protect Sport SunscreenBROAD SPECTRUM SPF 30Opal Day Spa564704f2-b26a-d737-e063-6294a90aa6ff2026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT MEDIUM NEUTRALZINC OXIDECOSMAX USA, CORP5647162a-610e-2789-e063-6294a90a75492026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT MEDIUM OLIVEZINC OXIDECOSMAX USA, CORP56472adb-572d-5a52-e063-6294a90a3cc32026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 MEDIUM COOLZINC OXIDECOSMAX USA, CORP56474782-beff-8437-e063-6294a90a83222026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 MEDIUM PEACHZINC OXIDECOSMAX USA, CORP564749f3-e820-9003-e063-6294a90a02652026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 TAN NEUTRALZINC OXIDECOSMAX USA, CORP56477f58-3878-81fa-e063-6294a90a87b72026-07-10WarningsExact 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
69473-021-026947300210215 mL in 1 TUBE (69473-021-02) 15 ml2024-12-04NoNoCurrent