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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2024

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

  • Product Facts

  • Active Ingredients

    Clear Shield:

    Titanium Dioxide 7%

    Zinc Oxide 6.18%

    Intensive Recovery:

    Hydrocortisone 1.0%

  • Purpose

    Clear Shield:

    Sunscreen

    Intensive Recovery:

    Anti-itch cream

  • Uses

    Clear Shield:

    • helps prevent sunburn

    Intensive Recovery:

    • adults and children 2 years of age and older: For the temporary relief of minor skin irritations, rashes, itching and redness due to eczema, insect bites, poison ivy, poison oak, poison sumac, contact dermatitis (e.g. caused by soaps, detergents, cosmetics and/or jewelry), seborrheic dermatitis, psoriasis.
  • Warnings

    For external use only

    Do not use

    Clear Shield:

    • on broken skin

    Intensive Recovery:

    • for the treatment of diaper rash, except on the advice of a physician

    When using this product

    Clear Shield:

    • avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Intensive Recovery:

    • avoid contact with eyes, do not use in or around the eyes

    Stop use and ask a doctor

    Clear Shield:

    • if rash occurs

    Intensive Recovery:

    • if condition worsens or if symptoms persist for more than 7 days or clears up and occurs again within a few days. Do not begin use of any other hydrocortisone product unless directed by a physician.

    Keep out of reach of children

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

  • Directions

    Clear Shield:

    • apply liberally/generously (and evenly) 15 minutes before sun exposure
    • reapply at least every 2 hours
    • 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

    Intensive Recovery:

    • adults and children 2 years of age and older, apply sparingly to affected area not more than three to four times daily
    • do not use on children under 2 years of age, consult a physician
  • Other Information

    Clear Shield:

    • Store in a cool, dry place at room temperature.
    • Do not use if security seal on box is broken or missing.
    • You may report a serious adverse reaction event from using this product to: Alumier Labs Inc., 945 Concord Street, Framingham, MA 01701

    Intensive Recovery:

    • Do not use if security seal on box is broken or missing.
    • You may report a serious adverse reaction event from using this product to: Alumier Labs Inc., 945 Concord Street, Framingham, MA 01701
  • Non-medicinal ingredients

    Clear Shield:

    Water/Aqua/Eau, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Niacinamide, Propanediol, Dimethicone, Butyloctyl Salicylate, Glycerin, Caprylyl Methicone, Cetearyl Alcohol, Aluminium Stearate, Glyceryl Stearate, PEG-100 Stearate, Vitis Vinifera Seed Extract, Sodium Hyaluronate, Resveratrol, Lecithin, Magnesium Ascorbyl Phosphate, Tocopheryl Acetate, Glutathione, Acacia Senegal Gum, Cellulose Gum, Microcrystalline Cellulose, Polysilicone-11, Triethoxycaprylylsilane, Ceteareth-20, Polyhydroxystearic Acid, Xanthan Gum, Disodium EDTA, Alumina, Tocopherol, Alteromonas Ferment Extract, Butylene Glycol, Physalis Angulata Extract, Polygonum Aviculare Extract, Xylitol, Caprylic Acid, Caprylyl Glycol, Polymethyl Methacrylate, Tricaprylin, Sodium Benzoate, Potassium Sorbate, Pentylene Glycol, Ethylhexylglycerin.

    Intensive Recovery:

    Water/Aqua/Eau, Butyrospermum Parkii (Shea Butter), Simmondsia Chinensis (Jojoba) Seed Oil, Glycerin, Caprylic/Capric Triglyceride, Dimethicone, Propanediol, Theobroama Cacao (Cocoa) Seed Butter, Aloe Barbadensis Leaf Juice, Niacinamide, Resveratrol, Poria Cocos Sclerotium Extract, Boswellia Serrata Gum Extract, Honey Extract (Extait De. Miel), Tetrapeptide-14, Copper Tripeptide-1, Aspalathus Linearis Extract, Ceramide NP, Ceramide NG, Squalane, Hydrogenated Lecithin, Sodium Acrylates Copolymer, Lecithin, Behenyl Alchol, Xanthan Gum, Caprylic Acid, Sodium Methyl Stearoyl Taurate, Tricaprylin, Polymethyl Methacrylate, Sodium Hydroxide, Disodium EDTA, Caprylyl Glycol, Xylitol, Ethylhexylglycerin.

  • Product Packaging

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    2

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  • INGREDIENTS AND APPEARANCE
    ALUMIER MD POST PROCEDURE KIT WITH HYDROCORTISONE 
    titanium dioxide, zinc oxide, hydrocortisone kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69473-020
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69473-020-011 in 1 CARTON; Type 0: Not a Combination Product10/25/2024
    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 CLEAR SHIELD BROAD SPECTRUM SPF 42 SUNSCREEN 
    titanium dioxide, zinc oxide lotion
    Product Information
    Item Code (Source)NDC:69473-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE61.8 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE70 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    CAPRYLIC ACID (UNII: OBL58JN025)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TRICAPRYLIN (UNII: 6P92858988)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CAPRYLYL METHICONE (UNII: Q95M2P1KJL)  
    POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    WATER (UNII: 059QF0KO0R)  
    ACACIA (UNII: 5C5403N26O)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    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)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PHYSALIS ANGULATA (UNII: W4TKW9D5GG)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    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 DrugM02010/23/2024
    Part 2 of 3
    ALUMIER MD SENSICALM GENTLE FACIAL CLEANSER 
    cleansing (cold creams, cleansing lotions, liquids, and pads) [skin care preparations (creams, lotions, powder, and sprays)] cream
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
    INGRSORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    INGRCERAMIDE NG (UNII: C04977SRJ5)  
    INGRPOLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRSUCROSE STEARATE (UNII: 274KW0O50M)  
    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)  
    INGRSODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    INGRACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)  
    INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    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
    Cosmetic10/23/2024
    Part 3 of 3
    ALUMIER MD INTENSIVE RECOVERY 
    hydrocortisone cream
    Product Information
    Item Code (Source)NDC:69473-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PREZATIDE COPPER (UNII: 6BJQ43T1I9)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    HONEY (UNII: Y9H1V576FH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TRICAPRYLIN (UNII: 6P92858988)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM METHYL STEAROYL TAURATE (UNII: JFM219LJ55)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    JOJOBA OIL (UNII: 724GKU717M)  
    RESVERATROL (UNII: Q369O8926L)  
    ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
    SQUALANE (UNII: GW89575KF9)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CAPRYLIC ACID (UNII: OBL58JN025)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CERAMIDE 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
    OTC Monograph DrugM01710/25/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/25/2024
    Labeler - Alumier Labs (079603173)