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Product NDC Code | 0311-0710 | ||||
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Drug Name | Almay smart shade anti-aging skintone matching makeup spf 20 |
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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 | LIQUID | ||||
Application Number | part352 | ||||
Labeler Name | Almay, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients: Titanium Dioxide: 5.5% Zinc Oxide 2.4%
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients CYCLOPENTASILOXANE, AQUA ((WATER) EAU), DIMETHICONE, PHENYL TRIMETHICONE, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIMETHYLSILOXYSILICATE, BUTYLENE GLYCOL, METHYL METHACRYLATE CROSSPOLYMER, SILICA, NYLON-12, TRIBEHENIN, DIMETHICONE/PEG-10/15 CROSSPOLYMER, ALUMINA, TOCOPHERYL ACETATE, NIACINAMIDE, PISUM SATIVUM (PEA) EXTRACT, GLYCINE SOJA (SOYBEAN) OIL, HYDROLYZED RICE PROTEIN, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) SEED EXTRACT, LAMINARIA JAPONICA EXTRACT, NEREOCYSTIS LUETKEANA EXTRACT, MACROCYSTIS PYRIFERA (KELP) EXTRACT, SACCHAROMYCES/MAGNESIUM FERMENT, SACCHAROMYCES/POTASSIUM FERMENT, PALMITOYL HYDROXYPROPYLTRIMONIUM AMYLOPECTIN/GLYCERIN CROSSPOLYMER, SODIUM HYALURONATE, OLIGOPEPTIDE-24, GLYCERIN, PALMITOYL TRIPEPTIDE-5, MELANIN, POLYESTER-1, LAURETH-7, MAGNESIUM SULFATE, POLYGLYCERYL-3 DIISOSTEARATE, METHICONE, TRIETHOXYCAPRYLYLSILANE, POLYSILICONE-11, DISTEARDIMONIUM HECTORITE, ETHYLENE BRASSYLATE, SILICA DIMETHYL SILYLATE, TRIETHYL CITRATE, TETRASODIUM EDTA, DIPROPYLENE GLYCOL, SODIUM CITRATE, TOCOPHEROL, PENTYLENE GLYCOL, MALTODEXTRIN, SUCROSE DILAURATE, SODIUM COCOYL GLUTAMATE, PHENOXYETHANOL, ETHYLPARABEN, METHYLPARABEN
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
Spl product data elements
Usually a list of ingredients in a drug product.ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 Titanium Dioxide, Zinc Oxide WATER PHENYL TRIMETHICONE GLYCERIN ALUMINUM OXIDE HYALURONATE SODIUM DIMETHICONE BUTYLENE GLYCOL NYLON-12 PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) SILICON DIOXIDE TRIBEHENIN .ALPHA.-TOCOPHEROL ACETATE NIACINAMIDE PEA SOYBEAN ALMOND PALMITOYL TRIPEPTIDE-5 MELANIN SYNTHETIC (TYROSINE, PEROXIDE) LAURETH-7 POLYSORBATE 20 MAGNESIUM SULFATE, UNSPECIFIED FORM CYCLOMETHICONE 5 POLYGLYCERYL-3 DIISOSTEARATE POLYSILICONE-15 DISTEARDIMONIUM HECTORITE ETHYLENE BRASSYLATE TRIETHYL CITRATE SILICA DIMETHYL SILYLATE EDETATE SODIUM DIPROPYLENE GLYCOL SODIUM CITRATE TOCOPHEROL PENTYLENE GLYCOL MALTODEXTRIN SUCROSE DILAURATE SODIUM COCOYL GLUTAMATE PHENOXYETHANOL ETHYLPARABEN METHYLPARABEN LAMINARIA JAPONICA NEREOCYSTIS LUETKEANA ZINC OXIDE ZINC CATION TITANIUM DIOXIDE TITANIUM DIOXIDE
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 Almay ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 1 oz/ 30mL Label
Instructions for use
Information about safe handling and use of the drug product.Directions •Apply liberally 15 minutes before sun exposure •Use a water resistant sunscreen if swimming or sweating •Reapply at least every 2 hours •Children under 6 months: Ask a doctor.
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.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.
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 notuse on damaged or broken skin •When using this product: Keep out of eyes. Rinse with water to remove. •Stop use and ask a doctor if a rash occurs •Keep out of reach of children. If product is 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