FDA.reportPublic FDA data

Alumier MD Sheer Hydration

Manufacturer
Alumier Labs
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:43:22

Label at a glance#

ProductAlumier MD Sheer Hydration
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure8 sections

Dosage and administration

apply liberally/generously (and evenly) 15 minutes before sun exposure reapply at least every 2 hours for use on children less than 6 months of age, consult a health care practitioner Sun Protection Measures : Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection mea...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 7%

Zinc Oxide 6.28%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

  • For external use only.

OTC - WHEN USING SECTION

When using this product

  • do not use on damaged or broken skin
  • keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if you develop severe irritation, burning or itching of the skin, hives, swelling of eyes and mouth, blistering or difficulty breathing

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, call a Poison Control Centre or get medical help right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally/generously (and evenly) 15 minutes before sun exposure
  • reapply at least every 2 hours
  • for use on children less than 6 months of age, consult a health care practitioner
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: - limit time in the sun, especially from 10 a.m.-2 p.m. - wear long-sleeved shirts, pants, hats and sunglasses
  • use a water resistant sunscreen if swimming or sweating

Other Information

OTHER SAFETY INFORMATION

  • Do not use if security seal is broken or missing.
  • You may report a serious adverse reaction event from using this product to: Alumier Labs Inc., 550 Cochituate Road, Suite 25, Framingham, MA 01701

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Propanediol, Butyloctyl Salicylate, Cetearyl Alcohol, Aluminium Stearate, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Lecithin (Syn. Phosphatidycholine), Vitis Vinifera Seed Extract, Resveratrol, Glutathione, Tocopheryl Acetate, Magnesium Ascorbyl Phosphate, Acacia Senegal Gum, Synthetic Wax, Polyhydroxysteric Acid, Ceteareth-20, Alumina, Microcrystalline Cellulose, Triethoxycaprylylsilane, Xanthan Gum, Cellulose Gum, C20-4O Pareth-10, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Polyquatemium-67, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol.

Product Packaging - 236 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alumier MD

Sheer Hydration

Broad Spectrum SPF 40

MOISTURIZING SUNSCREEN LOTION

UNTINTED

NPN 80064932

236 mL / 8 fl oz

sheer hydration revsheer hydration rev

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69473-006-01Alumier MD Sheer Hydration1 in 1 CARTONLOTION15
69473-006-01Alumier MD Sheer Hydration236 mL in 1 TUBELOTION2365
69473-006-02Alumier MD Sheer Hydration1 in 1 CARTONLOTION15
69473-006-02Alumier MD Sheer Hydration60 mL in 1 TUBELOTION605
69473-006-03Alumier MD Sheer Hydration8 mL in 1 TUBELOTION85

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69473-006ALUMIER MD SHEER HYDRATION (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ALUMIER LABS]5Current NDC, Legacy NDC, 5 package rows20241215_88dedeb8-963f-5849-e053-2995a90aab72.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69473-00669473-006-01, 69473-006-02, 69473-006-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ALUMINUM MONOSTEARATEP9BC99461EIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
ACACIA5C5403N26OIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
ALUMINUM OXIDELMI26O6933IACT
XANTHAN GUMTTV12P4NEEIACT
HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE9CO8OUL4THIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PROPANEDIOL5965N8W85TIACT
GLUTATHIONEGAN16C9B8OIACT
MAGNESIUM ASCORBYL PHOSPHATE0R822556M5IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
EDETATE DISODIUM7FLD91C86KIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
C20-40 PARETH-10TE3MZI4V3FIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERINPDC6A3C0OXIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
RESVERATROLQ369O8926LIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alumier MD Sheer HydrationTITANIUM DIOXIDE, ZINC OXIDEAlumier Labs88dedeb8-963f-5849-e053-2995a90aab722024-12-12WarningsExact identifier
ndc (package): 69473-006-03
ndc (package): 69473-006-01
ndc (package): 69473-006-02
ndc (product): 69473-006
ndc11 (package): 69473000603
ndc11 (package): 69473000601
ndc11 (package): 69473000602
spl id: 29183596-a25c-8192-e063-6394a90ad380
spl set id: 88dedeb8-963f-5849-e053-2995a90aab72

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.