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Solar defense tinted - Medication Information

Product NDC Code 60934-005
Drug Name

Solar defense tinted

Type Brand
Pharm Class Copper Absorption Inhibitor [EPC],
Decreased Copper Ion Absorption [PE]
Active Ingredients
Titanium dioxide 25 mg/ml
Zinc oxide 60 mg/ml
Route TOPICAL
Dosage Form CREAM
Application Number M020
Labeler Name HydroPeptide LLC
Packages
Package NDC Code Description
60934-005-01 1 tube in 1 box (60934-005-01) / 50 ml in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Titanium Dioxide (2.5%) Zinc Oxide (6%) 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, Acrylates/Ammonium Methacrylate Copolymer, Allantoin, Aloe Barbadensis Leaf Juice, Alpinia Galanga Extract, Alumina, Benzyl Benzoate, Benzyl Salicylate, Biotin, Boron Nitridem, Butylene Glycol, C12-15 Alkyl Benzoate, Calendula Officinalis Flower Extract, Camellia Oleifera Leaf Extract, Caprylyl Glycol, Caprylyl Methicone, Cellulose Acetate, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Chlorphenesin, Citral, Citric Acid Cucumis Sativus (Cucumber) Fruit Extract, Cyclomethicone, Cyclophentasiloxane, Dimethicone , Disodium EDTA, Ethylhexyl Palmitate, Euterpe Oleracea Fruit Extract, Fragrance, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Hexyl Cinnamal, Hydrolyzed Yeast Protein, Hydroxyethyl Acylate/Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxide (CI 77491), Iron Oxide (CI 77492), Iron Oxide (CI 77499), Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone, Lilial, Limonene, Niacinamide, Panthenol, PEG-100 Stearate, Pentylene Glycol, Polyhydroxystearic Acid, Polysorbate 60, Propanediol, Propylene Glycol Stearate, Propylene Glycol, Pyridoxine HCl, Sodium Citrate, Sodium Hyaluronate, Sodium PCA, Thermus Thermophilus Ferment, Triethoxycaprylylsilane, Triethoxysilylethyl Polydimethylsiloxyethyl 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 Tinted TITANIUM DIOXIDE, ZINC OXIDE 1,2-HEXANEDIOL ALLANTOIN ALOE VERA LEAF ALUMINUM OXIDE BENZYL BENZOATE BENZYL SALICYLATE BIOTIN BORON NITRIDE BUTYLENE GLYCOL ALKYL (C12-15) BENZOATE CALENDULA OFFICINALIS FLOWER CAMELLIA OLEIFERA LEAF CAPRYLYL GLYCOL CAPRYLYL TRISILOXANE CELLULOSE ACETATE CETYL ALCOHOL CHAMOMILE CHLORPHENESIN CITRAL CUCUMBER CYCLOMETHICONE DIMETHICONE EDETATE DISODIUM ANHYDROUS ETHYLHEXYL PALMITATE ACAI GLYCERIN GLYCERYL MONOCAPRYLATE GLYCERYL MONOSTEARATE .ALPHA.-HEXYLCINNAMALDEHYDE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE BUTYLPHENYL METHYLPROPIONAL LIMONENE, (+)- NIACINAMIDE PANTHENOL PEG-100 STEARATE PENTYLENE GLYCOL POLYSORBATE 60 PROPANEDIOL PROPYLENE GLYCOL MONOSTEARATE PROPYLENE GLYCOL PYRIDOXINE HYDROCHLORIDE 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: Label3

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