ALUMIER MD CLEAR SHIELD BROAD SPECTRUM SPF 42 SUNSCREEN- titanium dioxide, zinc oxide lotion

Alumier MD Clear Shield Broad Spectrum SPF 42 Sunscreen by

Drug Labeling and Warnings

Alumier MD Clear Shield Broad Spectrum SPF 42 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 6.18%

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 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 (Grape) 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 - 60 mL

INGREDIENTS AND APPEARANCE

ALUMIER MD CLEAR SHIELD BROAD SPECTRUM SPF 42 SUNSCREEN 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	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
PHYSALIS ANGULATA (UNII: W4TKW9D5GG)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
NIACINAMIDE (UNII: 25X51I8RD4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
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)
ALUMINUM OXIDE (UNII: LMI26O6933)
XANTHAN GUM (UNII: TTV12P4NEE)
CETEARETH-20 (UNII: YRC528SWUY)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PROPANEDIOL (UNII: 5965N8W85T)
GLUTATHIONE (UNII: GAN16C9B8O)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XYLITOL (UNII: VCQ006KQ1E)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERIN (UNII: PDC6A3C0OX)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
RESVERATROL (UNII: Q369O8926L)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLIC ACID (UNII: OBL58JN025)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRICAPRYLIN (UNII: 6P92858988)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69473-011-01	1 in 1 CARTON	07/06/2020
1		60 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69473-011-02	8 mL in 1 TUBE; Type 0: Not a Combination Product	07/06/2020	01/01/2026
3	NDC: 69473-011-03	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	07/06/2020

Labeler - Alumier Labs (079603173)