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 222 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Halo Glow Skin Tint SPF 50 84507ZINC OXIDEe.l.f. Cosmetics, Inc.31314118-0fd6-5549-e063-6394a90a9d1f2025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84506ZINC OXIDEe.l.f. Cosmetics, Inc.313119be-c1f2-4cb0-e063-6294a90a03ca2025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50 -84516ZINC OXIDEe.l.f. Cosmetics, Inc.312dd439-5cc8-e034-e063-6394a90a5c762025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84504ZINC OXIDEe.l.f. Cosmetics, Inc.223efabb-d018-c337-e063-6394a90a56052025-03-25WarningsExact identifier
application number: M020
IT Cosmetics Your Skin But Better CC Plus Color Correcting Full Coverage Antiaging Hydrating Serum Broad Spectrum SPF 50 Plus Clear SunscreenHOMOSALATE, OCTISALATE AND OCTOCRYLENEIT COSMETICS, LLC9f8786cc-bef6-4449-8f31-dfc08de777342025-03-25WarningsExact identifier
application number: M020
it cosmetics Your Skin But Better CC Plus Oil Free Matte Poreless Finish Full Coverage Broad Spectrum SPF 40 Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCb7d184fb-4a9a-4720-9b00-bf0caa257a8c2025-03-25WarningsExact identifier
application number: M020
KISS New York Tinted MoisturizerZINC OXIDEIVY ENTERPRISES, INC.30cce5b1-ed41-5bf2-e063-6394a90aaf1d2025-03-24WarningsExact identifier
application number: M020
KISS New York Tinted MoisturizerZINC OXIDEIVY ENTERPRISES, INC.30df95da-4868-1414-e063-6294a90acdac2025-03-24WarningsExact identifier
application number: M020
KISS New York Tinted MoisturizerZINC OXIDEIVY ENTERPRISES, INC.30e1bd3c-6a0b-a8f8-e063-6394a90acfb72025-03-24WarningsExact identifier
application number: M020
KISS New York Tinted MoisturizerZINC OXIDEIVY ENTERPRISES, INC.30e1b4c9-0d77-b08a-e063-6394a90af6832025-03-24WarningsExact identifier
application number: M020
KISS New York Tinted MoisturizerZINC OXIDEIVY ENTERPRISES, INC.30e1ff3f-0fd0-2880-e063-6294a90a462f2025-03-24WarningsExact identifier
application number: M020
KISS New York Tinted MoisturizerZINC OXIDEIVY ENTERPRISES, INC.30e25241-0d2b-8c04-e063-6294a90a44b92025-03-24WarningsExact identifier
application number: M020
Walgreens SPF 50 Clear Complexion Face SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY311ae6d6-d466-3f1d-e063-6294a90ab3dd2025-03-24WarningsExact identifier
application number: M020
DOMINAS DARK SPOT TINTED SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H CO., LTD.2b6140cf-7e34-1658-e063-6394a90a32712025-03-24WarningsExact identifier
application number: M020
CVS Health SPF 70 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacy311de9db-941c-5af9-e063-6294a90a3a132025-03-24WarningsExact identifier
application number: M020
CVS Health SPF 70 Beach Guard ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacy311e6378-5afa-d7eb-e063-6394a90a77282025-03-24WarningsExact identifier
application number: M020
Naked Sundays Golden Glow Body Sunscreen SPF50 100mlNAKED SUNDAYS GOLDEN GLOW BODY SUNSCREEN SPF50 100MLNAKED SUNDAYS PTY LTDe182a39b-89b1-7756-e053-2a95a90ab6192025-03-23WarningsExact identifier
application number: M020
ANTIOXIDANT BODY SUNSCREEN CREME SPF50 BROAD SPECTRUMAVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G,NAKED SUNDAY PTY LTDeb7a84a8-3e25-9988-e053-2a95a90a58a92025-03-23WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 40mL with Pink Algae SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD01273e8c-aef0-d800-e063-6294a90abd492025-03-23WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40mL with wild Rosella SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD01221d57-9eec-7e77-e063-6394a90a60422025-03-23WarningsExact 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