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 226 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sum 37 Micro Active Daily Moisture SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.2eea94e1-2409-8ad6-e063-6294a90a5df82025-03-03WarningsExact identifier
application number: M020
Sun Defense Minerals (Fair)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e21c9f9-acf8-997b-e063-6394a90ada3f2025-03-01WarningsExact identifier
application number: M020
Sun Defense Minerals (Medium)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e232e8d-4274-68bc-e063-6394a90a942b2025-03-01WarningsExact identifier
application number: M020
Sun Defense Minerals (Deep)ZINC OXIDEEminence Organic Skin Care2e23d463-fbc1-5718-e063-6294a90a72722025-03-01WarningsExact identifier
application number: M020
Sun Defense Minerals (Deep)ZINC OXIDEEminence Organic Skin Care2e24391f-4982-efae-e063-6394a90accaa2025-03-01WarningsExact identifier
application number: M020
FRUDIA Blueberry Hydrating Air Fit SunscreenOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEWELCOS CO.,LTD.8b2a1baa-e528-48d6-9cd8-c3cb55e0641b2025-02-28WarningsExact identifier
application number: M020
BRUSH ON BLOCK SPF 50 MINERALZINC OXIDESPF Ventures, LLC2f1b5454-8bf5-b447-e063-6394a90a743a2025-02-27WarningsExact identifier
application number: M020
Clear Defense SPF 45ZINC OXIDE, OCTINOXATEPrivate Label Skin Cared681d92f-3501-4fca-b629-096341f20ab12025-02-27WarningsExact identifier
application number: M020
HA Physical Tint SPF 44ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea5e19d77-703e-41e0-9a02-19227dc6c8192025-02-27WarningsExact identifier
application number: M020
Physical Daily Defense Broad Spectrum Sunscreen SPF 40ZINC OXIDEPrivate Label Skin Care18444581-66a4-4eda-a8df-627fa3b4b98a2025-02-26WarningsExact identifier
application number: M020
BRUSH ON BLOCK SPF 50 MINERAL TRANSLUCENT ZINC ONLY REFILLZINC OXIDE/TITANIUM DIOXIDESPF Ventures, LLC2f069114-9ca8-aed4-e063-6394a90a46d82025-02-26WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream230 NMelaleuca Inc.2f133abb-cad2-2ac8-e063-6294a90aa4802025-02-26WarningsExact identifier
application number: M020
BRUSH ON BLOCK SPF 50 KIDS MINERALZINC OXIDESPF Ventures, LLC2f17b5fe-44da-964b-e063-6394a90ae6992025-02-26WarningsExact identifier
application number: M020
Sun Defense Minerals (Tan)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2efb73a6-601d-61a4-e063-6294a90af8252025-02-25WarningsExact identifier
application number: M020
Rida Hair Research InstituteAVOBENZONE,OCTISALATE,OCTOCRYLENERida LLCece9dfd8-5f40-49b4-a97e-d4e6ffdb1dca2025-02-25WarningsExact identifier
application number: M020
COOLA Classic Body SPF 70 Peach BlossomAVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA, LLCed217698-f552-677e-e053-2995a90acb0a2025-02-25WarningsExact identifier
application number: M020
COOLA Classic Body SPF 30 Tropical CoconutAVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA, LLCed0f8249-aba8-b67c-e053-2a95a90af7eb2025-02-25WarningsExact identifier
application number: M020
Hydro Essence Broad Spectrum Sunscreen SPF 40ZINC OXIDE, OCTINOXATEPrivate Label Skin Caref176c1b1-f539-417f-98b5-69d99365f2f22025-02-25WarningsExact identifier
application number: M020
Sun Defense Minerals (Tan)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2ee82379-6609-fd8e-e063-6294a90acf6c2025-02-24WarningsExact identifier
application number: M020
Vacation SPF 50 ClassicAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVacation Inc.f2780cb5-063c-10d3-e053-2995a90a85762025-02-24WarningsExact 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