Label: ALUMIER MD SHEER HYDRATION TINTED MOISTURIZING SUNSCREEN- titanium dioxide, zinc oxide lotion
- NDC Code(s): 69473-010-01, 69473-010-02
- Packager: Alumier Labs
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 4, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- Use
- Warnings
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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
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Inactive Ingredients
Water/Aqua/Eau, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Propanediol, Butyloctyl Salicylate, Glycerin, Cetearyl Alcohol, Aluminium Stearate, Glyceryl Stearate, PEG-100 Stearate, Synthetic Fluorphlogopite, Lecithin (Syn. Phosphatidycholine), Vitis Vinifera Seed Extract, Resveratrol, Glutathione, Tocopheryl Acetate, Magnesium Ascorbyl Phosphate, Acacia Senegal Gum, Synthetic Wax, Polyhydroxystearic Acid, Ceteareth-20, Alumina, Microcrystalline Cellulose, Triethoxycaprylylsilane, Xanthan Gum, Cellulose Gum, C20-40 Pareth-10, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Polyquatemium-67, Disodium EDTA, Ammonium Polyacrylate, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Ethylhexylglycerin, Phenoxyethanol.
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Company Information
Alumier MD
ALUMIER EUROPE LTD.
5 ST. FREDERICK STREET
VALLETTA VLT 1470, MALTA
WWW.ALUMIERMD.COM
EUROPE • UNITED STATES • CANADA
UNITED KINGDOM
DISTRIBUTED IN CANADA BY
ALUMIER LABS INC.,
436 LIMESTONE CRESCENT
TORONTO, ON, M3J 2S4
DISTRIBUTED IN THE USA BY
ALUMIER LABS INC.,
550 COCHITUATE ROAD, SUITE 25
FRAMINGHAM, MA 01701
MANUFACTURED IN CANADA UNDER
LICENSE FROM ALUMIER EUROPE LTD.
- Product Packaging - 60 mL
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INGREDIENTS AND APPEARANCE
ALUMIER MD SHEER HYDRATION TINTED MOISTURIZING SUNSCREEN
titanium dioxide, zinc oxide lotionProduct 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 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) HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE (UNII: 9CO8OUL4TH) 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) C20-40 PARETH-10 (UNII: TE3MZI4V3F) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) 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) 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/30/2020 Labeler - Alumier Labs (079603173)
