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Face and body mineral spf - tinted - Medication Information

Product NDC Code 81535-210
Drug Name

Face and body mineral spf - tinted

Type Brand
Active Ingredients
Titanium dioxide 30 mg/g
Zinc oxide 100 mg/g
Route TOPICAL
Dosage Form AEROSOL, FOAM
Application Number part352
Labeler Name Flawless Skin Care, LLC (dba Abby Skin Clinic)
Packages
Package NDC Code Description
81535-210-01 100 g in 1 can (81535-210-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENTS: Titanium Dioxide 3% Zinc Oxide 10%

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: Shake well before using. Push nozzle up to release safety tab. Apply liberally 15 minutes before sun exposure. Reapply: After 40 minutes of swimming or sweating Immediately after towel drying At least every 2 hours Children under 6 months: Ask a doctor 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 am-2 pm Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENTS: Bismuth Oxychloride, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Disodium EDTA, Glycereth-26, Glycerin, Glyceryl Stearate, Iron Oxides, Methyl Methacrylate Crosspolymer, Mica, Microcrystalline Cellulose, Octyldodecyl Neopentanoate, Polymethyl Methacrylate, Polysorbate 80, Polyurethane-2, Trans-1,3,3,3-TetrafIuoropropene, Triacontanyl PVP, Triethoxycaprylylsilane,Trimethoxycaprylylsilane, Water

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: Helps prevent sunburn. If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Purpose

Information about the drug product’s indications for use.
PURPOSE: Sunscreen Sunscreen

Spl product data elements

Usually a list of ingredients in a drug product.
Face and Body Mineral SPF - Tinted Titanium Dioxide, Zinc Oxide Titanium Dioxide Titanium Dioxide Zinc Oxide Zinc Oxide BISMUTH OXYCHLORIDE BUTYLOCTYL SALICYLATE ALKYL (C12-15) BENZOATE CAPRYLHYDROXAMIC ACID CAPRYLYL GLYCOL CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM POLYOXYL 20 CETOSTEARYL ETHER CETOSTEARYL ALCOHOL CITRIC ACID MONOHYDRATE EDETATE DISODIUM ANHYDROUS GLYCERETH-26 GLYCERIN GLYCERYL MONOSTEARATE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER MICA MICROCRYSTALLINE CELLULOSE OCTYLDODECYL NEOPENTANOATE POLYHYDROXYSTEARIC ACID (2300 MW) POLY(METHYL METHACRYLATE; 450000 MW) POLYSORBATE 80 1,3,3,3-TETRAFLUOROPROPENE, (1E)- TRICONTANYL POVIDONE TRIETHOXYCAPRYLYLSILANE WATER

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.
Principal Display Panel - 100 g Can Label ABBY SKIN CARE ABBY ODIAMAR PACLIBAR FACE & BODY MINERAL SPF TINTED Oil Free Mousse Sunscreen broad spectrum SPF 30 water resistant (40 mins) Great for all skin types Photo-stable will not degrade in sunlight FREE of chemical sunscreen filters, dyes, fragrances, oils and preservatives Reef friendly non-comedogenic Net Wt. 3.5 oz | 100 g Principal Display Panel - 100 g Can Label

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
OTHER INFORMATION: Protect this product from excessive heat and direct sun May stain some fabrics Store between 68° to 104° F (20° to 40° C). Do not store at temperatures above 120° F.

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. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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