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

Alumier MD Post Procedure Kit by

Drug Labeling and Warnings

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

Drug Details [pdf]

Product Facts - Clear Shield

Active Ingredients

Titanium Dioxide 7%

Zinc Oxide 6.18%

Purpose

Sunscreen

Use

• helps prevent sunburn

Warnings

Do not use

• on broken skin

When using this product

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

Stop use and ask a doctor

if rash occurs

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
• 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

• 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

Non-medicinal ingredients

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.

Product Packaging

INGREDIENTS AND APPEARANCE

ALUMIER MD POST PROCEDURE KIT 
titanium dioxide, zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69473-019

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69473-019-01	1 in 1 CARTON; Type 0: Not a Combination Product	10/23/2024

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)
NIACINAMIDE (UNII: 25X51I8RD4)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
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)
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)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)

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	SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
INGR	ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
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	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	LINALOOL, (+/-)- (UNII: D81QY6I88E)
INGR	SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
INGR	CERAMIDE NG (UNII: C04977SRJ5)
INGR	SUCROSE STEARATE (UNII: 274KW0O50M)
INGR	POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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 RESCUE BALM PRO POST PROCEDURE FACIAL MOISTURIZER 
moisturizing [skin care preparations (creams, lotions, powder, and sprays)] cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	HYDROGENATED OLIVE OIL UNSAPONIFIABLES (UNII: B8MIX97W95)
INGR	FU LING (UNII: XH37TWY5O4)
INGR	LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	DOCOSANOL (UNII: 9G1OE216XY)
INGR	COCOA BUTTER (UNII: 512OYT1CRR)
INGR	NIACINAMIDE (UNII: 25X51I8RD4)
INGR	PREZATIDE COPPER (UNII: 6BJQ43T1I9)
INGR	INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
INGR	HONEY (UNII: Y9H1V576FH)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	TRICAPRYLIN (UNII: 6P92858988)
INGR	XYLITOL (UNII: VCQ006KQ1E)
INGR	SODIUM METHYL STEAROYL TAURATE (UNII: JFM219LJ55)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	PROPANEDIOL (UNII: 5965N8W85T)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	JOJOBA OIL (UNII: 724GKU717M)
INGR	RESVERATROL (UNII: Q369O8926L)
INGR	ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
INGR	SQUALANE (UNII: GW89575KF9)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	CAPRYLIC ACID (UNII: OBL58JN025)
INGR	HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	CERAMIDE NP (UNII: 4370DF050B)
INGR	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
Cosmetic		10/23/2024

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

Labeler - Alumier Labs (079603173)