ALUMIER MD POST PROCEDURE KIT- titanium dioxide, zinc oxide 
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.

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Alumier MD Post Procedure Kit

Drug Facts - Sheer Hydration

Active Ingredients

Titanium Dioxide 7%

Zinc Oxide 6.28%

Purpose

Sunscreen

Use

Warnings

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 Centre or get medical help right away.

Directions

Other Information

Inactive Ingredients

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

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

kit insidekit insertkit box

ALUMIER MD POST PROCEDURE KIT 
titanium dioxide, zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69473-012
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69473-012-011 in 1 CARTON; Type 0: Not a Combination Product11/30/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 15 mL
Part 21 TUBE 15 mL
Part 31 TUBE 15 mL
Part 1 of 3
ALUMIER MD SHEER HYDRATION 
titanium dioxide, zinc oxide lotion
Product Information
Item Code (Source)NDC:69473-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE62.8 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE70 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ACACIA (UNII: 5C5403N26O)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE (UNII: 9CO8OUL4TH)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
C20-40 PARETH-10 (UNII: TE3MZI4V3F)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
GLYCERIN (UNII: PDC6A3C0OX)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
ALUMINUM MONOSTEARATE (UNII: P9BC99461E)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
PROPANEDIOL (UNII: 5965N8W85T)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PEG-100 STEARATE (UNII: YD01N1999R)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
GLUTATHIONE (UNII: GAN16C9B8O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
RESVERATROL (UNII: Q369O8926L)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
115 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/30/2020
Part 2 of 3
ALUMIER MD SENSICALM 
cleansing (cold creams, cleansing lotions, liquids, and pads) cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRNIACINAMIDE (UNII: 25X51I8RD4)  
INGRALLANTOIN (UNII: 344S277G0Z)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRP-ANISIC ACID (UNII: 4SB6Y7DMM3)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRCAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
INGRXYLITOL (UNII: VCQ006KQ1E)  
INGRCAPRYLIC ACID (UNII: OBL58JN025)  
INGR4-TERPINEOL, (+/-)- (UNII: L65MV77ZG6)  
INGREDETATE SODIUM (UNII: MP1J8420LU)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRCOCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
INGRWATER (UNII: 059QF0KO0R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRPROPANEDIOL (UNII: 5965N8W85T)  
INGRSODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRYUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
INGRSUNFLOWER OIL (UNII: 3W1JG795YI)  
INGRLINALYL ACETATE (UNII: 5K47SSQ51G)  
INGR.BETA.-OCIMENE, (3Z)- (UNII: 472UVP4R7T)  
INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
INGRDISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
INGRSORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
INGRCERAMIDE NG (UNII: C04977SRJ5)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
115 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic07/01/2019
Part 3 of 3
ALUMIER MD RECOVERY BALM 
face and neck (excluding shaving preparations) cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRDOCOSANOL (UNII: 9G1OE216XY)  
INGRCOCOA BUTTER (UNII: 512OYT1CRR)  
INGRNIACINAMIDE (UNII: 25X51I8RD4)  
INGRPREZATIDE COPPER (UNII: 6BJQ43T1I9)  
INGRINDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
INGRHONEY (UNII: Y9H1V576FH)  
INGRCHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
INGRPATCHOULI OIL (UNII: F3IN55X5PO)  
INGRROSEMARY (UNII: IJ67X351P9)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRTRICAPRYLIN (UNII: 6P92858988)  
INGRXYLITOL (UNII: VCQ006KQ1E)  
INGRSODIUM METHYL STEAROYL TAURATE (UNII: JFM219LJ55)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRCRANBERRY (UNII: 0MVO31Q3QS)  
INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGRPROPANEDIOL (UNII: 5965N8W85T)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRJOJOBA OIL (UNII: 724GKU717M)  
INGR.BETA.-THUJAPLICIN (UNII: U5335D6EBI)  
INGRRESVERATROL (UNII: Q369O8926L)  
INGRLAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
INGRASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
INGREUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
INGRMENTHA SPICATA (UNII: O2H83I4PUN)  
INGRSQUALANE (UNII: GW89575KF9)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRGREEN TEA LEAF (UNII: W2ZU1RY8B0)  
INGRAPPLE (UNII: B423VGH5S9)  
INGRPSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
INGRPOLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRCAPRYLIC ACID (UNII: OBL58JN025)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
115 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic07/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/30/2020
Labeler - Alumier Labs (079603173)

Revised: 11/2022
Document Id: ecfac4c2-efaf-37b2-e053-2a95a90a3ad5
Set id: b5582f24-6da4-450d-e053-2a95a90a7964
Version: 2
Effective Time: 20221108
 
Alumier Labs