Label: ALUMIER MD SHEER HYDRATION- titanium dioxide, zinc oxide lotion

  • NDC Code(s): 69473-006-01, 69473-006-02, 69473-006-03
  • Packager: Alumier Labs
  • 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 March 28, 2022

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  • Drug Facts

  • 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., 550 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, C20-4O 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

    DISTRIBUTED IN CANADA BY

    ALUMIER LABS INC.,

    436 LIMESTONE CRESCENT

    TORONTO, ON, M3J 2S4

    DISTRIBUTED IN THE USA BY

    ALUMIER LABS INC.,

    550 COCHITUATE ROAD, SUITE 25

    FRAMINGHAM, MA 01701

    MANUFACTURED IN CANADA UNDER

    LICENSE FROM ALUMIER EUROPE LTD.

  • Product Packaging - 236 mL

    Alumier MD

    Sheer Hydration

    Broad Spectrum SPF 40

    MOISTURIZING SUNSCREEN LOTION

    UNTINTED

    NPN 80064932

    236 mL / 8 fl oz

    sheer hydration rev

  • INGREDIENTS AND APPEARANCE
    ALUMIER MD SHEER HYDRATION 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem 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
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALUMINUM MONOSTEARATE (UNII: P9BC99461E)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ACACIA (UNII: 5C5403N26O)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE (UNII: 9CO8OUL4TH)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLUTATHIONE (UNII: GAN16C9B8O)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    C20-40 PARETH-10 (UNII: TE3MZI4V3F)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    RESVERATROL (UNII: Q369O8926L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69473-006-011 in 1 CARTON07/01/2019
    1236 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69473-006-021 in 1 CARTON07/01/2019
    260 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:69473-006-038 mL in 1 TUBE; Type 0: Not a Combination Product07/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/01/2019
    Labeler - Alumier Labs (079603173)
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