FDA.reportPublic FDA data

Alumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen Ivory

Manufacturer
Alumier Labs
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:40:24

Label at a glance#

ProductAlumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen Amber
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure11 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 ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Amber Shade:

Titanium Dioxide 8.3%

Zinc Oxide 9%

Ivory and Sand Shades:

Titanium Dioxide 7.8%

Zinc Oxide 9%

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 Center 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

Cyclopentasiloxane, Water/Aqua/Eau, Squalane, PEG-10 Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Glycerin, Argania Spinosa Kernel Oil, Butylene Glycol, Disteardimonium Hectorite, Tocopheryl Acetate, Hexyl Laurate, Polymethylsilsesquioxane, Polyglyceryl-4 Isostearate, Caffeine, Sodium Chloride, Polygonum Aviculare Extract, Sodium Hyaluronate, Lecithin (Syn. Phosphatidylcholine), Silybin, Bisabolol, Phenethyl Alcohol, Stearic Acid, Alumina, Mica, Polyester-1, Silica Dimethyl Silylate, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Ethylhexylglycerin, Phenoxyethanol.

Company Information

SPL UNCLASSIFIED SECTION

Distributed in the USA by Alumier Labs Inc.,

550 Cochituate Road, Suite 25

Framingham, MA 01701

Product Packaging - Amber

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

amberamber

Product Packaging - Ivory

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ivory revivory rev

Product Packaging - Sand

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sand revsand rev

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69473-014-01Alumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen Amber60 mL in 1 TUBELOTION605
69473-014-01Alumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen Amber1 in 1 CARTONLOTION15
69473-014-02Alumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen Amber8 mL in 1 TUBELOTION85
69473-015-01Alumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen Ivory1 in 1 CARTONLOTION15
69473-015-01Alumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen Ivory60 mL in 1 TUBELOTION605
69473-015-02Alumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen Ivory8 mL in 1 TUBELOTION85
69473-016-01Alumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen Sand1 in 1 CARTONLOTION15
69473-016-01Alumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen Sand60 mL in 1 TUBELOTION605
69473-016-02Alumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen Sand8 mL in 1 TUBELOTION85

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69473-014ALUMIER MD MOISTURE MATTE BROAD SPECTRUM SPF 40 SUNSCREEN AMBER (ZINC OXIDE, TITANIUM DIOXIDE) LOTION ALUMIER MD MOISTURE MATTE BROAD SPECTRUM SPF 40 SUNSCREEN SAND (ZINC OXIDE, TITANIUM DIOXIDE) LOTION ALUMIER MD MOISTURE MATTE BROAD SPECTRUM SPF 40 SUNSCREEN IVORY (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [ALUMIER LABS]5Current NDC, Legacy NDC, 3 package rows20241206_ba864a08-e66d-d286-e053-2995a90a1854.zip
69473-015ALUMIER MD MOISTURE MATTE BROAD SPECTRUM SPF 40 SUNSCREEN AMBER (ZINC OXIDE, TITANIUM DIOXIDE) LOTION ALUMIER MD MOISTURE MATTE BROAD SPECTRUM SPF 40 SUNSCREEN SAND (ZINC OXIDE, TITANIUM DIOXIDE) LOTION ALUMIER MD MOISTURE MATTE BROAD SPECTRUM SPF 40 SUNSCREEN IVORY (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [ALUMIER LABS]5Current NDC, Legacy NDC, 3 package rows20241206_ba864a08-e66d-d286-e053-2995a90a1854.zip
69473-016ALUMIER MD MOISTURE MATTE BROAD SPECTRUM SPF 40 SUNSCREEN AMBER (ZINC OXIDE, TITANIUM DIOXIDE) LOTION ALUMIER MD MOISTURE MATTE BROAD SPECTRUM SPF 40 SUNSCREEN SAND (ZINC OXIDE, TITANIUM DIOXIDE) LOTION ALUMIER MD MOISTURE MATTE BROAD SPECTRUM SPF 40 SUNSCREEN IVORY (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [ALUMIER LABS]5Current NDC, Legacy NDC, 3 package rows20241206_ba864a08-e66d-d286-e053-2995a90a1854.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69473-01469473-014-01, 69473-014-02
69473-01669473-016-01, 69473-016-02
69473-01569473-015-01, 69473-015-02

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 96 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
SQUALANEGW89575KF9IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HEXYL LAURATE4CG9F9W01QIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
POLYGONUM AVICULARE TOPZCD6009IUFIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
ARGAN OIL4V59G5UW9XIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
CYCLOMETHICONE 50THT5PCI0RIACT
GLYCERINPDC6A3C0OXIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
STEARIC ACID4ELV7Z65APIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
SODIUM CHLORIDE451W47IQ8XIACT
HYALURONATE SODIUMYSE9PPT4THIACT
SILIBININ4RKY41TBTFIACT
LEVOMENOL24WE03BX2TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAFFEINE3G6A5W338EIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
ALUMINUM OXIDELMI26O6933IACT
MICAV8A1AW0880IACT
FERRIC OXIDE RED1K09F3G675IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
SQUALANEGW89575KF9IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HEXYL LAURATE4CG9F9W01QIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT

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 Moisture Matte Broad Spectrum SPF 40 Sunscreen AmberZINC OXIDE, TITANIUM DIOXIDEAlumier Labsba864a08-e66d-d286-e053-2995a90a18542024-12-03WarningsExact identifier
ndc (package): 69473-016-02
ndc (package): 69473-014-01
ndc (package): 69473-016-01
ndc (package): 69473-015-02
ndc (package): 69473-014-02
ndc (package): 69473-015-01
ndc (product): 69473-015
ndc (product): 69473-016
ndc (product): 69473-014
ndc11 (package): 69473001502
ndc11 (package): 69473001501
ndc11 (package): 69473001601
ndc11 (package): 69473001401
ndc11 (package): 69473001402
ndc11 (package): 69473001602
spl id: 28689862-f8cc-5f28-e063-6294a90ac654
spl set id: ba864a08-e66d-d286-e053-2995a90a1854

Reported adverse events (FAERS/openFDA)#

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