ALUMIER MD SHEER HYDRATION TINTED MOISTURIZING SUNSCREEN- titanium dioxide, zinc oxide lotion

Alumier MD Sheer Hydration Tinted Moisturizing Sunscreen by

Drug Labeling and Warnings

Alumier MD Sheer Hydration Tinted Moisturizing Sunscreen 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

Titanium Dioxide 7%

Zinc Oxide 6.28%

Purpose

Sunscreen

Use

• helps prevent sunburn

Warnings

• For external use only.

Do not use

• on broken or damaged 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
• adults 18 years and older
• 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, Propanediol, Glycerin, Butyloctyl Salicylate, Squalane, Cetearyl Alcohol, Aluminium Stearate, Glyceryl Stearate, Peg-100 Stearate, Lecithin, Vitis Vinifera (Grape) Seed Extract, Resveratrol, Glutathione, Tocopheryl Acetate, Magnesium Ascorbyl Phosphate, Acacia Senegal Gum, Sodium Hyaluronate, Polyhydroxystearic Acid, Ceteareth-20, Alumina, Microcrystalline Cellulose, Triethoxycaprylylsilane, Physalis Angulata Extract, Pongamia Pinnata Seed Extract, Polygonum Aviculare Extract, Hydrogenated Olive Oil Unsaponifiables, Alteromonas Ferment Extract, Pentylene Glycol, 1,2-hexanediol, Polymethyl Methacrylate, Caprylyl Glycol, Xylitol, Caprylic Acid, Butylene Glycol, Cellulose Gum, Xanthan Gum, Tricaprylin, Sodium Benzoate, Potassium Sorbate, Disodium EDTA, Sodium Polyacrylate, Tocopherol, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Ethylhexylglycerin.

Product Packaging - 60 mL

INGREDIENTS AND APPEARANCE

ALUMIER MD SHEER HYDRATION TINTED MOISTURIZING SUNSCREEN 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69473-010
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
CAPRYLIC ACID (UNII: OBL58JN025)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
HYDROGENATED OLIVE OIL UNSAPONIFIABLES (UNII: B8MIX97W95)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHYSALIS ANGULATA (UNII: W4TKW9D5GG)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
XYLITOL (UNII: VCQ006KQ1E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALUMINUM MONOSTEARATE (UNII: P9BC99461E)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
ACACIA (UNII: 5C5403N26O)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
ALUMINUM OXIDE (UNII: LMI26O6933)
XANTHAN GUM (UNII: TTV12P4NEE)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PROPANEDIOL (UNII: 5965N8W85T)
GLUTATHIONE (UNII: GAN16C9B8O)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
TRICAPRYLIN (UNII: 6P92858988)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERIN (UNII: PDC6A3C0OX)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
RESVERATROL (UNII: Q369O8926L)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SQUALANE (UNII: GW89575KF9)
POLYGONUM AVICULARE WHOLE (UNII: M990N03611)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
TOCOPHEROL (UNII: R0ZB2556P8)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PONGAMIA PINNATA SEED EXTRACT (UNII: C2BRV53B1V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69473-010-01	1 in 1 CARTON	06/30/2020
1		60 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69473-010-02	8 mL in 1 TUBE; Type 0: Not a Combination Product	06/30/2020	12/03/2024
3	NDC: 69473-010-03	15 mL in 1 TUBE; Type 0: Not a Combination Product	12/03/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/30/2020

Labeler - Alumier Labs (079603173)