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| Product NDC Code | 66800-8004 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Coppertone kids sunscreen spf 60 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | Beiersdorf Inc | ||||||||
| 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 ■ 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-sleeve shirts, pants, hats, and sunglasses ■ children under 6 months: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, styrene/acrylates copolymer, butyloctyl salicylate, diethylhexyl 2,6-naphthalate, polyester-7, cetearyl alcohol, glyceryl stearate, silica, neopentyl glycol diheptanoate, 1-2-hexandiol, copernicia cerifera (carnauba) wax, PPG-15 stearyl ether, silica dimethyl silylate, tapioca starch, tocopheryl acetate, sodium stearoyl glutamate, diethylhexyl syringylidenemalonate, hydroxyacetophenone, argania spinosa kernel oil, xanthan gum, glycereth-26, glycerin, disodium EDTA, fragrance, bisabolol
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 sun 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.Coppertone Kids Sunscreen SPF 60 Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10% NEOPENTYL GLYCOL DIHEPTANOATE HYDROXYACETOPHENONE CETOSTEARYL ALCOHOL DIETHYLHEXYL 2,6-NAPHTHALATE SILICA DIMETHYL SILYLATE STARCH, TAPIOCA XANTHAN GUM GLYCERIN HOMOSALATE HOMOSALATE POLYESTER-7 CALCIUM SILICATE DISODIUM STEAROYL GLUTAMATE AVOBENZONE AVOBENZONE GLYCERETH-26 DISODIUM EDTA-COPPER 1,2-HEXANEDIOL CARNAUBA WAX WATER OCTOCRYLENE OCTOCRYLENE BUTYLOCTYL SALICYLATE ARGAN OIL .BETA.-BISABOLOL OCTISALATE OCTISALATE STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) GLYCERYL STEARATE SE PPG-15 STEARYL ETHER .ALPHA.-TOCOPHEROL ACETATE, DL- DIETHYLHEXYL SYRINGYLIDENEMALONATE FRAGRANCE FLORAL ORC0902236
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.Coppertone ® Sunscreen Lotion #1 Pediatrician Recommended Sunscreen Brand Kids 60+ Stays on Strong even in water Free of Oxybenzone, Octinoxate, PABA, Phthalates & Dyes Water Resistant (80 Minutes) Sroad Spectrum SPF 60+ 6.5 FL OZ (192 mL) Kids 60+ Lotion
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
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information ■ protect this product from excessive heat and direct sun ■ may stain or damage some fabrics or surfaces
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-866-288-3330
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