FDA.reportPublic FDA data

Alumier MD Sheer Hydration Broad Spectrum SPF40 Untinted

Manufacturer
CSR Cosmetic Solutions Inc.
Effective date
2021-10-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:34:09

Label at a glance#

ProductAlumier MD Sheer Hydration Broad Spectrum SPF40 Untinted
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
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 measu...

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.

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor

OTC - STOP USE SECTION

If you develop severe irritation, burning or itching of the skin, hives, swelling of eyes and mouth, blistering or difficulty breathing

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

SPL UNCLASSIFIED SECTION

  • 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, Suit 25, Framingham, MA 01701

Inactive Ingredients

INACTIVE INGREDIENT SECTION

1911023 - Water/Aqua, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Propanediol, Butylocyl 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, C20-40 Pareth-10, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Polyquaternium-67, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol.

Package Labeling: 60mL (49354-061-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

Package Labeling: 236mL(49354-061-02)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package2Outer Package2Inner Package2Inner Package2

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49354-06149354-061-00, 49354-061-02

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
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PROPANEDIOL5965N8W85TIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ALUMINUM STEARATEU6XF9NP8HMIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
RESVERATROLQ369O8926LIACT
GLUTATHIONEGAN16C9B8OIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MAGNESIUM ASCORBYL PHOSPHATE0R822556M5IACT
ACACIA5C5403N26OIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
ALUMINUM OXIDELMI26O6933IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
XANTHAN GUMTTV12P4NEEIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
C20-40 PARETH-10TE3MZI4V3FIACT
HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE9CO8OUL4THIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
cda0059d-81f4-6efe-e053-2995a90af02f32a07b7b-74c8-4074-9b54-78f520e4a3cb2021-10-05WarningsExact identifier
spl id: cda0059d-81f4-6efe-e053-2995a90af02f
spl set id: 32a07b7b-74c8-4074-9b54-78f520e4a3cb

Reported adverse events (FAERS/openFDA)#

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