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

Alumier MD Post Procedure Kit with Hydrocortisone by

Drug Labeling and Warnings

Alumier MD Post Procedure Kit with Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Alumier Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69473-020

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69473-020-01	1 in 1 CARTON; Type 0: Not a Combination Product	10/25/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	15 mL
Part 2	1 TUBE	15 mL
Part 3	1 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 Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	61.8 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1		15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/23/2024

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 Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	LINALOOL, (+/-)- (UNII: D81QY6I88E)
INGR	SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
INGR	CERAMIDE NG (UNII: C04977SRJ5)
INGR	POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	SUCROSE STEARATE (UNII: 274KW0O50M)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	NIACINAMIDE (UNII: 25X51I8RD4)
INGR	ALLANTOIN (UNII: 344S277G0Z)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	P-ANISIC ACID (UNII: 4SB6Y7DMM3)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
INGR	XYLITOL (UNII: VCQ006KQ1E)
INGR	CAPRYLIC ACID (UNII: OBL58JN025)
INGR	4-TERPINEOL, (+/-)- (UNII: L65MV77ZG6)
INGR	EDETATE SODIUM (UNII: MP1J8420LU)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	PROPANEDIOL (UNII: 5965N8W85T)
INGR	SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)
INGR	SUNFLOWER OIL (UNII: 3W1JG795YI)
INGR	LINALYL ACETATE (UNII: 5K47SSQ51G)
INGR	.BETA.-OCIMENE, (3Z)- (UNII: 472UVP4R7T)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A)
INGR	SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
INGR	ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		10/23/2024

Part 3 of 3

ALUMIER MD INTENSIVE RECOVERY 
hydrocortisone cream

Product Information
Item Code (Source)	NDC: 69473-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1		15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/25/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/25/2024

Labeler - Alumier Labs (079603173)