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| Product NDC Code | 61973-101 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Arizona sun sunscreen spf15 |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | LOTION | ||||||||||
| Application Number | M020 | ||||||||||
| Labeler Name | Arizona Sun Products | ||||||||||
| 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 Ethylhexyl Methoxycinnamate (7.50%) Ethylhexyl Salicylate (3.00%) Benzophenone-3 (3.00%) Butyl Methoxydibenzoylmethane (Avobenzone) (2.00%)
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.Drug Facts
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water (Agua), Stearic Acid, Propylene Glycol, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Cetyl Alcohol, Tocopheryl Acetate (Vitamin E), Retinyl Palmitate, Aloe Barbadensis (Aloe Vera) Leaf Juice, Rosa Canina (Rose Hips) Flower Extract, Salvia Officinalis (Sage) Leaf Extract, Verbascum Thapsus (Mullein) Extract, Lupinus Luteus Seed (Lupin) Extract, Humulus Lupulus (Hops) Extract, Cereus Grandiflorus (Cactus) Extract, Arctium Lappa (Burdock) Root Extract, Viscum Album (Mistletoe) Fruit Extract, Helianthus Annuus (Sunflower) Seed Extract, Polysorbate 60, Cetearyl Alcohol, Carbomer, Glycerin, Disodium EDTA, Triethanolamine, Phenoxyethanol, Ethylhexylglycerin, Fragrance
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 Provides minimal sunburn protection. Higher SPF gives more sunburn protection.
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.Arizona Sun Sunscreen SPF15 Sunscreen LUPINUS LUTEUS SEED WATER MULLEIN LEAF ROSA CANINA FLOWER HOPS ETHYLHEXYLGLYCERIN OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE AVOBENZONE AVOBENZONE PEG-100 STEARATE VITAMIN A PALMITATE SIMMONDSIA CHINENSIS SEED TROLAMINE ALOE VERA LEAF SELENICEREUS GRANDIFLORUS FLOWER SUNFLOWER SEED PROPYLENE GLYCOL DIMETHICONE SAGE POLYSORBATE 60 GLYCERIN PHENOXYETHANOL VISCUM ALBUM FRUIT STEARIC ACID CETYL ALCOHOL OXYBENZONE OXYBENZONE GLYCERYL STEARATE SE .ALPHA.-TOCOPHEROL ACETATE STEARYL ALCOHOL DISODIUM EDTA-COPPER ARCTIUM LAPPA ROOT CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
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.1ozspf15
Instructions for use
Information about safe handling and use of the drug product.Directions Apply liberally and evenly to the skin 30 minutes before and during sun exposure. Reapply as needed or after towel drying, perspiring, swimming, and vigorous activities. Use on children under six months of age only wih the advise of a physician.
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 the reach of children. If swallowed get medical help or contact a poison control center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Sun Alert: Limiting sun exposure, wearing protective clothing, and using suscreen may reduce the risk of skin aging, skin cancer and other harmful effects of the sun.
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 toll free 1-800-442-4786
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 or irritation develops and lasts.
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. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts. 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