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| Product NDC Code | 59450-978 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Sunscreen |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | SPRAY | ||||||||
| Application Number | part352 | ||||||||
| Labeler Name | The Kroger Co | ||||||||
| 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 Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 10%
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 ■ apply to all skin exposed to the sun ■ 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, regularly 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, styrene/acrylates copolymer, silica, diethylhexyl 2,6-naphthalate, beeswax, glyceryl stearate, PEG-100 stearate, glycerin, caprylyl methicone, cetyl dimethicone, sodium polyacrylate, acrylates/C12-22 alkyl methacrylate copolymer, dimethicone, xanthan gum, pentylene glycol, trimethylsiloxysilicate, disodium EDTA, fragrance, BHT, benzyl alcohol, chlorphenesin
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 skin protection 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 AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE Alcohol WATER STYRENE SILICON DIOXIDE DIETHYLHEXYL 2,6-NAPHTHALATE YELLOW WAX GLYCERYL MONOSTEARATE PEG-100 STEARATE GLYCERIN CAPRYLYL TRISILOXANE CETYL DIMETHICONE 150 SODIUM POLYACRYLATE (2500000 MW) BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER DIMETHICONE XANTHAN GUM PENTYLENE GLYCOL TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) EDETATE DISODIUM ANHYDROUS BUTYLATED HYDROXYTOLUENE BENZYL ALCOHOL CHLORPHENESIN
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 Neutrogena Ultra Sheer Dry-Touch Sunscreen *see back panel Kroger Dry Touch Sheer Sunscreen Lotion Broad Spectrum SPF 70 water resistant (80 mins) UVA/UVB protection won't clog pores clean & lightweight feel dermatologist tested SPF 70 Reef friendly* 3 FL OZ (88 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.Claims Kroger dry-touch SHEER sunscreen lotion is a broad spectrum sunscreen that absorbs quickly and leaves your skin feeling smooth and soft, with no greasy residue.
Other information protect the product in the container from excessive heat and direct sun
MAY STAIN OR DAMAGE SOME FABRICS OR SURFACES. *Neutrogena and ultra sheer are registered trademarks of Johnson & Johnson Corporation, New Brunswick, NJ 09933. Johnson & Johnson Corporation is not affiliated with the Kroger Co. or this product. **OXYBENZONE & OCTINOXATE FREE Quality guarantee 800-632-6900 www.kroger.com
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? 1-800-632-6990
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