ALUMIER MD SHEER HYDRATION BROAD SPECTRUM SPF40 UNTINTED- titanium dioxide, zinc oxide cream

Alumier MD Sheer Hydration Broad Spectrum SPF40 Untinted by

Drug Labeling and Warnings

Alumier MD Sheer Hydration Broad Spectrum SPF40 Untinted by is a Otc medication manufactured, distributed, or labeled by CSR Cosmetic Solutions Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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., 550 Cochituate Road, Suit 25, Framingham, MA 01701

Inactive Ingredients

1911023 - Water/Aqua, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Propanediol, Butylocyl 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, Polyquaternium-67, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol.

Package Labeling: 60mL (

49354-061-00)

Package Labeling: 236mL(

49354-061-02)

INGREDIENTS AND APPEARANCE

ALUMIER MD SHEER HYDRATION BROAD SPECTRUM SPF40 UNTINTED 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49354-061
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	70 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	62.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPANEDIOL (UNII: 5965N8W85T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
RESVERATROL (UNII: Q369O8926L)
GLUTATHIONE (UNII: GAN16C9B8O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
ACACIA (UNII: 5C5403N26O)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
ALUMINUM OXIDE (UNII: LMI26O6933)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
C20-40 PARETH-10 (UNII: TE3MZI4V3F)
HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE (UNII: 9CO8OUL4TH)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49354-061-00	1 in 1 CARTON	07/01/2019
1		60 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49354-061-02	1 in 1 CARTON	07/01/2019
2		236 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	07/01/2019

Labeler - CSR Cosmetic Solutions Inc. (243501959)