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]

Drug Facts - Sheer Hydration

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., 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, C20-40 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

MANUFACTURED IN CANADA UNDER LICENSE FROM ALUMIER EUROPE LTD.

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: 69473-012

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69473-012-01	1 in 1 CARTON; Type 0: Not a Combination Product	11/30/2020

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 SHEER HYDRATION 
titanium dioxide, zinc oxide lotion

Product Information
Item Code (Source)	NDC: 69473-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	62.8 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ACACIA (UNII: 5C5403N26O)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE (UNII: 9CO8OUL4TH)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
C20-40 PARETH-10 (UNII: TE3MZI4V3F)
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)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

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 not final	part352	11/30/2020

Part 2 of 3

ALUMIER MD SENSICALM 
cleansing (cold creams, cleansing lotions, liquids, and pads) cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
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)

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		07/01/2019

Part 3 of 3

ALUMIER MD RECOVERY BALM 
face and neck (excluding shaving preparations) cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
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	CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
INGR	PATCHOULI OIL (UNII: F3IN55X5PO)
INGR	ROSEMARY (UNII: IJ67X351P9)
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	PENTYLENE GLYCOL (UNII: 50C1307PZG)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	CRANBERRY (UNII: 0MVO31Q3QS)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	PROPANEDIOL (UNII: 5965N8W85T)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	JOJOBA OIL (UNII: 724GKU717M)
INGR	.BETA.-THUJAPLICIN (UNII: U5335D6EBI)
INGR	RESVERATROL (UNII: Q369O8926L)
INGR	LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
INGR	ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
INGR	EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
INGR	MENTHA SPICATA (UNII: O2H83I4PUN)
INGR	SQUALANE (UNII: GW89575KF9)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	GREEN TEA LEAF (UNII: W2ZU1RY8B0)
INGR	APPLE (UNII: B423VGH5S9)
INGR	PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
INGR	POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	CAPRYLIC ACID (UNII: OBL58JN025)

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		07/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/30/2020

Labeler - Alumier Labs (079603173)