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| Product NDC Code | 76144-000 | ||||
|---|---|---|---|---|---|
| Drug Name | Paulas choice hydralight shine-free daily mineral complex broad spectrum spf 30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | Paula's Choice, Inc | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Titanium Dioxide 2.32% Zinc Oxide 6.0% Purpose Sunscreen
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.apply liberally 15 minutes before sun exposure use a water-resistant sunscreen if swimming or sweating. reapply at least every two hours if skin exposed to sun. 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 of 15 or higher and other sun protection measures including: Sun Protection Measures. limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Ethylhexyl Palmitate, Cyclomethicone, Dimethicone, Polysorbate 80, Caprylyl Methicone, Glyceryl Stearate, PEG-100 Stearate, C12-15 Alkyl Benzoate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Cetyl Alcohol, Propylene Glycol, Polyglyceryl-6 Isostearate, Camellia Sinensis (Green Tea) Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomila Recutita (Matricaria) Flower Extract, Algae Extract, Aloe Barbadensis Leaf Juice, Allantoin, Glycerin, Panthenol, Butylene Glycol, Caprylyl Glycol, Alumina, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Polyhydroxystearic Acid, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Diethylhexyl Carbonate, Triethoxycaprylylsilane, Disodium EDTA, Chlorphenesin, Phenoxyethanol.
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 ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
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.PAULAS CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX Broad Spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE GLYCERYL MONOSTEARATE PEG-100 STEARATE ALKYL (C12-15) BENZOATE ISOHEXADECANE CETYL ALCOHOL PROPYLENE GLYCOL GREEN TEA LEAF GLYCYRRHIZA GLABRA CHAMOMILE ALOE VERA LEAF ALLANTOIN GLYCERIN PANTHENOL BUTYLENE GLYCOL CAPRYLYL GLYCOL ALUMINUM OXIDE LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE DIETHYLHEXYL CARBONATE TRIETHOXYCAPRYLYLSILANE EDETATE DISODIUM CHLORPHENESIN PHENOXYETHANOL WATER ETHYLHEXYL PALMITATE CYCLOMETHICONE DIMETHICONE POLYSORBATE 80 CAPRYLYL TRISILOXANE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC 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.PAULA'S CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX Broad Spectrum SPF 30 Normal Oily Combination with Antioxidants moisturizer + spf 60 ml / 2 fl. oz.
PAULA'S CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX Broad Spectrum SPF 30 60ml (76144-000-00) Paulas Choice
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.PAULA'S CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX Broad Spectrum SPF 30
Other Information protect this product from excessive heat and direct sun you may report serious and adverse reactions to 1030 SW 34th Street, Suite A, Renton, WA 98057
What it does: * Light lotion leaves soft, matte finish * Great for sensitive skin and rosacea * Prevents signs of aging "Make sun protection an every day habit like brushing your teeth." Paula Begour Clinically proven non-irritating. 100% fragrance free. No added dyes. No animal testing. Made in USA. Manufactured for Paula's Choice, Inc. Seattle, WA 98057. Paula's Choice is a registered trademark of Paula's Choice, Inc. 1.800.831.4088 (U.S. and Canada) PaulasChoice.com
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on damaged or broken skin.
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.If product is swallowed, get medical help or contact a Poison Control 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 rash occurs.
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. Rinse with water to remove.
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. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. 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