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 233 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.2cc8f7ef-eda3-fe71-e063-6394a90a6a9a2025-01-28WarningsExact identifier
application number: M020
Baby Diaper Rash CreamZINC OXIDEdoTERRA International, LLC641465a1-0daf-1bb9-e053-2a91aa0ab25d2025-01-28WarningsExact identifier
application number: M020
HydroPeptide S.P.F. Sun Protection FriendsTITANIUM DIOXIDE, ZINC OXIDEHydroPeptide LLCf3669a1e-8b75-4e94-a3f0-71dcbc3fa9142025-01-28WarningsExact identifier
application number: M020
doTERRA sun Face Daily MoisturizerZINC OXIDEdoTERRA International, LLCf3836517-e3ec-5e9e-e053-2a95a90a7af12025-01-28WarningsExact identifier
application number: M020
doTERRA sunZINC OXIDEdoTERRA International, LLCda5c48d6-1859-983d-e053-2a95a90a4c3e2025-01-28WarningsExact identifier
application number: M020
doTERRA sunZINC OXIDEdoTERRA International, LLCdd2fa6a2-2ba8-4333-e053-2a95a90a97902025-01-28WarningsExact identifier
application number: M020
Tri-water sheer mineral sunscreen cushion SPF30ZINC OXIDEEden Brands Inc.2cd22172-78cb-32f3-e063-6394a90a395d2025-01-28WarningsExact identifier
application number: M020
SOS Face Guard Broad Spectrum Sunscreen SPF 30ZINC OXIDETower 286687006a-bd79-4e1c-a546-0f0b51b299482025-01-28WarningsExact identifier
application number: M020
LBEL CONCENTRE GLOBAL ANTI AGING SERUM CONCEALER SPF 15 EYES FACE ALMENDRA 230OCTINOXATE, ZINC OXIDEBEL STAR S.A.2cb1a767-3228-71ea-e063-6294a90ac89e2025-01-27WarningsExact identifier
application number: M020
Meijer SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer26f7566e-5a89-21cf-e063-6294a90ac8862025-01-27WarningsExact identifier
application number: M020
TiZO Photoceutical AM Replenish Non-TintedZINC OXIDEFallien Cosmeceuticals, LTD2cb77125-ff77-2060-e063-6294a90ab69f2025-01-27WarningsExact identifier
application number: M020
GLOW RECIPE WATERMELON GLOW DEW SHIELD HYDRATING FLUID SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEAramara Beauty LLC dba Glow Recipe2cb90666-6517-a02c-e063-6294a90ab0622025-01-27WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEZ&Z Skin Essentials2cdc48f3-474f-9c06-e063-6294a90afea12025-01-27WarningsExact identifier
application number: M020
Cetaphil Sheer Mineral Sunscreen Stick SPF 50TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.54f6df65-e90c-4070-aa95-f47496dd11bd2025-01-27WarningsExact identifier
application number: M020
Cetaphil Healthy Renew Day Cream Broad Spectrum SPF 30HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEGalderma Laboratories, L.P.5b4e25ad-cd72-4960-9259-fc710bfd59da2025-01-27WarningsExact identifier
application number: M020
Well People Daygleamer Liquid Mineral Sunscreen SPF 34ZINC OXIDEe.l.f. Cosmetics, Inc.2c7621e9-0f1d-4712-e063-6294a90abd642025-01-24WarningsExact identifier
application number: M020
Equate Sunscreen SPF 30 SPORT Broad SpectrumAVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENEWal-Mart Stores Inc1697628a-91d2-45bc-bd1b-91fb38f3f8df2025-01-24WarningsExact identifier
application number: M020
DR.JART EVERY SUN DAY SUN FLUIDHOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEHave & Be Co., Ltd.f06d8f90-f3df-6d76-e053-2a95a90af1f82025-01-24WarningsExact identifier
application number: M020
CoTZ Silky Foam - TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDd63088d7-a1d7-4b56-a7d8-ad217011a8a82025-01-24WarningsExact identifier
application number: M020
CoTZ Silky Foam Non-TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD9c04b76e-ae65-4183-b475-3b8e8764db592025-01-24WarningsExact 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