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| Product NDC Code | 79903-007 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Tanning sunscreen uvb protection dry oil equate |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | AEROSOL, SPRAY | ||||||
| Application Number | M020 | ||||||
| Labeler Name | WAL-MART STORES INC. | ||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Avobenzone 2.0%, Homosalate 10.0%, Octisalate 5.0%
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 • Spray liberally and spread evenly by hand 15 minutes before sun exposure • Hold can 4-6 inches away from the skin to apply • Do not spray directly into face. Spray into hands then apply to face • Do not apply in windy conditions • Use in a well-ventilated area • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months of age: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients alcohol denat., tridecyl salicylate, acrylates/octylacrylamide copolymer, glycerin, mineral oil, 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 • helps prevent sunburn • Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early signs of aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
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.Tanning Sunscreen UVB Protection Dry Oil Equate Avobenzone, Homosalate, Octisalate ALCOHOL GLYCERIN HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) LIGHT MINERAL OIL AVOBENZONE AVOBENZONE TRIDECYL SALICYLATE
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.Label Equate Tanning Sunscreen UVB Protection SPF 15 Spray Dry Oil 5.5 oz (156 g) NDC 79903-007-37 Label EQ36696A2
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop use and Ask a doctor if • rash occurs.
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 swallowed, get medical help or contact a Poison Control Center right away.
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. • Keep away from face to avoid breathing it. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120°F.
Storage and handling
Information about safe storage and handling of the drug product.Other information • protect the product in this container from excessive heat and direct sun • may stain or damage some fabrics, materials or surfaces
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 FLAMMABLE: • do not use near heat, flame or while smoking • avoid long term storage above 104°F (40°C)
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