Label: 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

  • NDC Code(s): 69473-014-01, 69473-014-02, 69473-015-01, 69473-015-02, view more
    69473-016-01, 69473-016-02
  • 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 8, 2022

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

View All Sections
  • 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

    • 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 Center 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

    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

  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!