ALUMIER 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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Alumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen

Drug Facts

Active ingredients

Amber Shade:

Titanium Dioxide 8.3%

Zinc Oxide 9%

Ivory and Sand Shades:

Titanium Dioxide 7.8%

Zinc Oxide 9%

Purpose

Sunscreen

Use

Warnings

For external use only.

When using this product

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

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.

Keep out of reach of children.

If swallowed, call a Poison Control Center or get medical help right away.

Directions

Other information

Inactive ingredients

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

Distributed in the USA by Alumier Labs Inc.,

550 Cochituate Road, Suite 25

Framingham, MA 01701

Product Packaging - Amber

amber

Product Packaging - Ivory

ivory rev

Product Packaging - Sand

sand rev

ALUMIER MD MOISTURE MATTE BROAD SPECTRUM SPF 40 SUNSCREEN AMBER 
zinc oxide, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69473-014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE90 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE83 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SQUALANE (UNII: GW89575KF9)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ARGAN OIL (UNII: 4V59G5UW9X)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SILIBININ (UNII: 4RKY41TBTF)  
LEVOMENOL (UNII: 24WE03BX2T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAFFEINE (UNII: 3G6A5W338E)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69473-014-011 in 1 CARTON02/04/2021
160 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:69473-014-028 mL in 1 TUBE; Type 0: Not a Combination Product02/04/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/04/2021
ALUMIER MD MOISTURE MATTE BROAD SPECTRUM SPF 40 SUNSCREEN SAND 
zinc oxide, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69473-016
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE90 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE78 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SQUALANE (UNII: GW89575KF9)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ARGAN OIL (UNII: 4V59G5UW9X)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SILIBININ (UNII: 4RKY41TBTF)  
LEVOMENOL (UNII: 24WE03BX2T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAFFEINE (UNII: 3G6A5W338E)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69473-016-011 in 1 CARTON02/04/2021
160 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:69473-016-028 mL in 1 TUBE; Type 0: Not a Combination Product02/04/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/04/2021
ALUMIER MD MOISTURE MATTE BROAD SPECTRUM SPF 40 SUNSCREEN IVORY 
zinc oxide, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69473-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE90 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE78 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SQUALANE (UNII: GW89575KF9)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ARGAN OIL (UNII: 4V59G5UW9X)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SILIBININ (UNII: 4RKY41TBTF)  
LEVOMENOL (UNII: 24WE03BX2T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAFFEINE (UNII: 3G6A5W338E)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69473-015-011 in 1 CARTON02/04/2021
160 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:69473-015-028 mL in 1 TUBE; Type 0: Not a Combination Product02/04/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/04/2021
Labeler - Alumier Labs (079603173)

Revised: 3/2022
Document Id: d9b597f3-6f69-a0d0-e053-2995a90a3a28
Set id: ba864a08-e66d-d286-e053-2995a90a1854
Version: 3
Effective Time: 20220308
 
Alumier Labs