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| Product NDC Code | 66800-8002 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Coppertone every tone age defense 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 at least every 2 hours ■ use a water resistant sunscreen if swimming or sweating ■ 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 dicaprylyl carbonate, butylene glycol dicaprylate/dicaprate, silica dimethyl silylate, neopentyl glycol diheptanoate, dibutyl adipate, dimethicone, dextrin palmitate, coco- caprylate/caprate, acetyl ethylhexyl polyhydroxystearate, butyloctyl salicylate, diethylhexyl 2,6-naphthalate, diisopropyl adipate, poly C10-30 alkyl acrylate, triheptanoin, silica, alcohol denat., dimethicone/vinyl dimethicone crosspolymer, bakuchiol, stearalkonium hectorite, dimethicone crosspolymer, C12-15 alkyl benzoate, 12-hydroxy stearic acid, dilinoleic acid/butanediol copolymer, propylene carbonate, ethylhexyl palmitate, hydroxyacetophenone, quaternium-90 bentonite, fragrance, stearic acid, castor oil/IPDI copolymer, water, palmitic acid
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 Every Tone Age Defense Sunscreen SPF 60 Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10% DEXTRIN PALMITATE (CORN; 20000 MW) ALCOHOL STEARALKONIUM HECTORITE C12-20 ALKYL BENZOATE WATER QUATERNIUM-90 BENTONITE ETHYLHEXYL PALMITATE SILICA DIMETHYL SILYLATE PROPYLENE CARBONATE HYDROXYACETOPHENONE DIISOPROPYL ADIPATE FRAGRANCE FRESH CITRUS FLORAL ORC1501495 STEARIC ACID PALMITIC ACID COCO-CAPRYLATE/CAPRATE HOMOSALATE HOMOSALATE DIMETHICONE, UNSPECIFIED DICAPRYLYL CARBONATE DILINOLEIC ACID/BUTANEDIOL COPOLYMER 12-HYDROXYSTEARIC ACID BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE DIBUTYL ADIPATE TRIHEPTANOIN CASTOR OIL/IPDI COPOLYMER OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE BUTYLOCTYL SALICYLATE CALCIUM SILICATE ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) BAKUCHIOL DIETHYLHEXYL 2,6-NAPHTHALATE NEOPENTYL GLYCOL DIHEPTANOATE AVOBENZONE AVOBENZONE DIMETHICONE CROSSPOLYMER POLYVINYL ACETATE
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.NEW Coppertone® Clear Sunscreen Every Tone Invisible Finish Face 60+ Age UV Defense plus Bakuchiol Transparent on all skin tones Won't clog pores Broad Spectrum SPF 60+ 1.7 FL OZ (50 mL) CPT age defense
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