Label: ALUMIER MD POST PROCEDURE KIT- titanium dioxide, zinc oxide kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated November 30, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts - Sheer Hydration

  • Active Ingredients

    Titanium Dioxide 7%

    Zinc Oxide 6.28%

  • Purpose

    Sunscreen

  • Use

    • helps prevent sunburn
  • 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 Centre or get medical help right away.

  • Directions

    • 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

    • 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

    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

  • INGREDIENTS AND APPEARANCE
    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 BROAD SPECTRUM SPF 40 
    titanium dioxide, zinc oxide lotion
    Product Information
    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)