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

Alumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen Ivory by

Drug Labeling and Warnings

Alumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen Ivory by is a Otc medication manufactured, distributed, or labeled by Alumier Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Product Packaging - Ivory

Product Packaging - Sand

INGREDIENTS AND APPEARANCE

ALUMIER MD MOISTURE MATTE BROAD SPECTRUM SPF 40 SUNSCREEN AMBER 
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69473-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	90 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	83 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69473-014-01	1 in 1 CARTON	02/04/2021
1		60 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69473-014-02	8 mL in 1 TUBE; Type 0: Not a Combination Product	02/04/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/04/2021

ALUMIER MD MOISTURE MATTE BROAD SPECTRUM SPF 40 SUNSCREEN SAND 
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69473-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	90 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	78 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69473-016-01	1 in 1 CARTON	02/04/2021
1		60 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69473-016-02	8 mL in 1 TUBE; Type 0: Not a Combination Product	02/04/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/04/2021

ALUMIER MD MOISTURE MATTE BROAD SPECTRUM SPF 40 SUNSCREEN IVORY 
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69473-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	90 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	78 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69473-015-01	1 in 1 CARTON	02/04/2021
1		60 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69473-015-02	8 mL in 1 TUBE; Type 0: Not a Combination Product	02/04/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/04/2021

Labeler - Alumier Labs (079603173)