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Product NDC Code | 62742-4095 | ||||
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Drug Name | Sheerzinc spf 30 tinted - tan |
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Type | Brand | ||||
Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Application Number | part352 | ||||
Labeler Name | Allure Labs Inc | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient: Zinc oxide - 18.6%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions: Apply sunscreen in the AM to finger tips and gently massage into the skin. Reapply as needed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other Ingredients: Water (Aqua), Cyclopentasiloxane, Butylene glycol, glycerin, Caprylic/Capric triglyceride, Glycerin Stearate, PEG-100 Stearate, Polyglyceryl-3 Polymethylsiloxyeethyl Dimethicon, Cyclohexasiloxane, Sorbitan Stearate, Dimethicone, Polyacrylamide, C13-14 Isoparaffin, Laureth-7,phenoxyethanol, Caprylyl Glycol, Ethylhexyglycerin, Hexylene glycol, Imperata Cylindrica Root Extract, PEG-8, Carbomer, triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Cetyl Alcohol, Lecithin, Tocopherol, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Xanthan gum, Polyester-7, Neopentyl Glycol Diheptanoate, tocopherol Linoleate/Oleate, Teprenone, Phoenix Dactylifera (Date) Fruit Extract, Polygonum Aviculare Extract, Sodium Lactate, Disodium EDTA, Dipotassium Glycyrrhizate, Arabidopsis Thaliana Extract, Plankton Extract, Micrococcus Lysate, Triethoxycaprylysilane, Iron Oxides (CI77491, CI77492, CI77499)
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses: To help protect the skin from harmful UVA and UVB rays
Purpose
Information about the drug product’s indications for use.Purpose: Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.SheerZinc SPF 30 Tinted - Tan Zinc Oxide ZINC OXIDE ZINC CATION WATER DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) BUTYLENE GLYCOL GLYCERIN MEDIUM-CHAIN TRIGLYCERIDES GLYCERYL STEARATE SE PEG-100 STEARATE POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) CYCLOMETHICONE 6 SORBITAN MONOSTEARATE DIMETHICONE C13-14 ISOPARAFFIN LAURETH-7 PHENOXYETHANOL CAPRYLYL GLYCOL ETHYLHEXYLGLYCERIN HEXYLENE GLYCOL IMPERATA CYLINDRICA ROOT POLYETHYLENE GLYCOL 400 CARBOMER 1342 CETYL ALCOHOL LECITHIN, SOYBEAN TOCOPHEROL ASCORBYL PALMITATE ASCORBIC ACID CITRIC ACID MONOHYDRATE XANTHAN GUM POLYESTER-7 NEOPENTYL GLYCOL DIHEPTANOATE .ALPHA.-TOCOPHEROL LINOLEATE, D- TEPRENONE DATE POLYGONUM AVICULARE TOP SODIUM LACTATE EDETATE DISODIUM ANHYDROUS GLYCYRRHIZINATE DIPOTASSIUM ARABIDOPSIS THALIANA MICROCOCCUS LUTEUS TRIETHOXYCAPRYLYLSILANE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Manufactured for DermaQuest, Inc. Hayward, CA 94544 1272 GK, NL Made in USA dermaquestinc.com ImageSheerZnTan20
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children: If swallowed, get medical help or contact a Poison Cpntrol center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor If severe skin irritation developes
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product: Keep out of eyes. If contact occurs, rinse with water. Discontinue use if irritation or redness occurs.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings: For external use only
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API