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| Product NDC Code | 30142-764 | ||||||||||
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| Drug Name | Sunscreen |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | LOTION | ||||||||||
| Application Number | part352 | ||||||||||
| Labeler Name | The Kroger Co | ||||||||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Adverse Reaction DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202 QUALITY GUARANTEE 800-632-6900 www.kroger.com May stain or damage some fabrics or surfaces.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Avobenzone 3% Homosalate 11.7% Octisalate 4.5% Octocrylene 4.5% Oxybenzone 5.4%
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 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk use reqularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: 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 water, propylene glycol, neopentyl glycol diheptanoate, styrene/acrylates copolymer, benzyl alcohol, tocopherol, triethanolamine, acrylates/C10-30 alkyl acrylate crosspolymer, oleth-3, polyamide-8, chlorphenesin, sodium ascorbyl phosphate, fragrance, disodium EDTA
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.Use helps prevent sunburn if used as directed with other sun protections measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
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.Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE oxybenzone OXYBENZONE water PROPYLENE GLYCOL NEOPENTYL GLYCOL DIHEPTANOATE STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) BENZYL ALCOHOL TOCOPHEROL TROLAMINE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) OLETH-3 POLYAMIDE-8 (4500 MW) CHLORPHENESIN SODIUM ASCORBYL PHOSPHATE EDETATE DISODIUM ANHYDROUS
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.Principal display panel compare to COPPERTONE SPORT *see back panel Kroger SPORT SUJNSCREEN LOTION BROAD SPECTRIUM SPF 50 NON-GREAS7Y, STAYS STROMG EVEN WHEN YOU START TO SWEAT WON'T RUN INTO EYES UVA/UVB sunscreen water resistant (80 minutes) hypoallergenic SPF 50 8 FL OZ (236 mL) image description
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.Other Information Protect the product from excessive heat and direct sun
disclaimer COPPERTONE AND COPPERTONE SPORT ARE REGISTERED TRADEMARKS OF BAYER, WHIPPANY, NJ 07981. BAYER IS NOT AFFILIATED WITH THE KROGER CO. OR THIS PRODUCT.
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
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? 1-800-632-6900
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
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