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| Product NDC Code | 60934-003 | ||||
|---|---|---|---|---|---|
| Drug Name | Solar defense non tinted |
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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 | M020 | ||||
| Labeler Name | HydroPeptide LLC | ||||
| 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 (3%) Zinc Oxide (7%) 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.Directions Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a suncreen with a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients 1,2-Hexanediol, Allantoin, Alpinia Galanga Extract, Alumina, Biotin, Butylene Glycol, C12-15 Alkly Benzoate, Calendula Officinalis Flower Extract, Camellia Oleifera Leaf Extract, Caprylyl Glycol, Caprylyl Methicone, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Chlorphenesin, Citric Acid Cucumis Sativus (Cucumber) Fruit Extract, Cyclomethicone, Cyclophentasiloxane, Dimethicone, Disodium EDTA, Ethylhexyl Palmitate, Euterpe Oleracea Fruit Extract, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Hydrolyzed Yeast Protein, Hydroxyethyl Acylate/Sodium Acryloyldimethyl Taurate Copolymer, Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone, Niacinamide, Panthenol, PEG-100 Stearate, Pentylene Glycol, Polyhydroxystearic Acid, Polysorbate 60, Propanediol, Propylene Glycol, Pyridoxine HCl, Saccharomyces Cerevisiae Extract, Sodium Citrate, Sodium Hyaluronate, Sodium PCA, Thermus Thermophilus Ferment, Triethoxycaprylylsilane, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Water, Xanthan Gum
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 usn 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.Solar Defense Non Tinted TITANIUM DIOXIDE, ZINC OXIDE 1,2-HEXANEDIOL ALLANTOIN ALUMINUM OXIDE BIOTIN BUTYLENE GLYCOL ALKYL (C12-15) BENZOATE CALENDULA OFFICINALIS FLOWER CAMELLIA OLEIFERA LEAF CAPRYLYL GLYCOL CAPRYLYL TRISILOXANE CETYL ALCOHOL CHAMOMILE CHLORPHENESIN CUCUMBER CYCLOMETHICONE DIMETHICONE EDETATE DISODIUM ANHYDROUS ETHYLHEXYL PALMITATE ACAI GLYCERIN GLYCERYL CAPRYLATE GLYCERYL MONOSTEARATE GLYCERYL 1-UNDECYLENATE LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE NIACINAMIDE PANTHENOL PEG-100 STEARATE PENTYLENE GLYCOL POLYSORBATE 60 PROPANEDIOL PROPYLENE GLYCOL PYRIDOXINE HYDROCHLORIDE SACCHAROMYCES CEREVISIAE SODIUM CITRATE HYALURONATE SODIUM SODIUM PYRROLIDONE CARBOXYLATE THERMUS THERMOPHILUS LYSATE TRIETHOXYCAPRYLYLSILANE WATER XANTHAN GUM TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC CATION
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.Package Labeling: Label
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.Drug Facts
Other Information Protect the product in this container from excessive heat and direct sun.
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.Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call 1.800.932.9873
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 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. 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