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NDC 69473-0006-01 Alumier MD Sheer Hydration 70; 62.8 mg/mL; mg/mL Details

Alumier MD Sheer Hydration 70; 62.8 mg/mL; mg/mL

Alumier MD Sheer Hydration is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Alumier Labs. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	69473-0006
Product ID	69473-006_db49f453-2212-4969-e053-2995a90abb0f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Alumier MD Sheer Hydration
Proprietary Name Suffix	n/a
Non-Proprietary Name	Titanium Dioxide, Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	70; 62.8
Active Ingredient Units	mg/mL; mg/mL
Substance Name	TITANIUM DIOXIDE; ZINC OXIDE
Labeler Name	Alumier Labs
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69473-0006-01 (69473000601)

Pricing Information	N/A
NDC Package Code	69473-006-01
Billing NDC	69473000601
Package	1 TUBE in 1 CARTON (69473-006-01) / 236 mL in 1 TUBE
Marketing Start Date	2019-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 88dedeb8-963f-5849-e053-2995a90aab72 Details

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, Suite 25, Framingham, MA 01701

Inactive Ingredients

Water/Aqua/Eau, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Propanediol, Butyloctyl 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, C20-4O Pareth-10, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Polyquatemium-67, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol.

Product Packaging - 236 mL

Alumier MD

Sheer Hydration

Broad Spectrum SPF 40

MOISTURIZING SUNSCREEN LOTION

UNTINTED

NPN 80064932

236 mL / 8 fl oz

INGREDIENTS AND APPEARANCE

ALUMIER MD SHEER HYDRATION

titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69473-006
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69473-006-01	1 in 1 CARTON	07/01/2019
1		236 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:69473-006-02	1 in 1 CARTON	07/01/2019
2		60 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC:69473-006-03	8 mL in 1 TUBE; Type 0: Not a Combination Product	07/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	07/01/2019

Labeler - Alumier Labs (079603173)

Revised: 3/2022

Document Id: db49f453-2212-4969-e053-2995a90abb0f

Set id: 88dedeb8-963f-5849-e053-2995a90aab72

Version: 2

Effective Time: 20220328