FDA.reportPublic FDA data

Alumier MD Post Procedure Prescription Hydrocortisone Free

Manufacturer
Alumier Labs
Effective date
2019-06-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:19:39

Label at a glance#

ProductAlumier MD Post Procedure Prescription Hydrocortisone Free
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure9 sections

Dosage and administration

apply liberally/generously (and evenly) 15 minutes before sun exposure reapply at least every 2 hours 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 ...

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
  • 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., 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, C20-40 Pareth-10, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Polyquatemium-67, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol.

Company Information

SPL UNCLASSIFIED SECTION

Alumier MD

ALUMIER EUROPE LTD.

5 ST. FREDERICK STREET

VALLETTA VLT 1470, MALTA

WWW.ALUMIERMD.COM

EUROPE • UNITED STATES • CANADA • UNITED KINGDOM

MANUFACTURED IN CANADA UNDER LICENSE FROM ALUMIER EUROPE LTD.

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alumier MD

Post Procedure Prescription

3 STEPS. 5 DAYS TO GLOWING SKIN.

insertinsertcarton2carton2carton1carton1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69473-009-012020-07-22C16284748780-1ab0e2407-2d1b-f274-e053-dbdaa90a6471Alumier MD Post Procedure Prescription Hydrocortisone Free

Products#

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

DailyMed product names page 1 of 3 · 84 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69473-00969473-009-01

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 98 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
WATER059QF0KO0RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ACACIA5C5403N26OIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE9CO8OUL4THIACT
MAGNESIUM ASCORBYL PHOSPHATE0R822556M5IACT
C20-40 PARETH-10TE3MZI4V3FIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERINPDC6A3C0OXIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
ALUMINUM MONOSTEARATEP9BC99461EIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
XANTHAN GUMTTV12P4NEEIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PROPANEDIOL5965N8W85TIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
EDETATE DISODIUM7FLD91C86KIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PEG-100 STEARATEYD01N1999RIACT
ALUMINUM OXIDELMI26O6933IACT
GLUTATHIONEGAN16C9B8OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
RESVERATROLQ369O8926LIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINGR
CETYL ALCOHOL936JST6JCNINGR
NIACINAMIDE25X51I8RD4INGR
ALLANTOIN344S277G0ZINGR
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0INGR
P-ANISIC ACID4SB6Y7DMM3INGR
XANTHAN GUMTTV12P4NEEINGR
SODIUM HYDROXIDE55X04QC32IINGR
CAPRYLYL/CAPRYL OLIGOGLUCOSIDEE00JL9G9K0INGR
XYLITOLVCQ006KQ1EINGR
CAPRYLIC ACIDOBL58JN025INGR

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
b635dc72-e2d1-fa40-e053-2995a90a6d858c42cfe8-fee4-9baf-e053-2995a90a986f2020-12-11WarningsExact identifier
spl set id: 8c42cfe8-fee4-9baf-e053-2995a90a986f

Reported adverse events (FAERS/openFDA)#

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