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Product NDC Code | 66800-8164 | ||||||||
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Drug Name | Coppertone oil free and shine control face sunscreen spf 45 |
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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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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Avobenzone 3%, Homosalate 10%, 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 40 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, alcohol denat., butyloctyl salicylate, silica,bis-octyldodecyl dimer dilinoleate/propanediol copolymer, glyceryl stearate, tapioca starch, behenyl alcohol, butylene glycol dicaprylate/dicaprate, C12-15 alkyl benzoate, cetearyl alcohol, copernicia cerifera (carnauba) wax, dibutyl adipate, tocopherol (Vitamin E), silica dimethyl silylate, sodium stearoyl glutamate, glyceryl behenate, polyglyceryl-6 octastearate, diethylhexyl syringylidenemalonate, phenoxyethanol, xanthan gum, ethylhexylglycerin, hydroxyacetophenone, disodium EDTA, glycerin, cetyl alcohol, sodium ascorbyl phosphate
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
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 Oil Free and Shine Control Face Sunscreen SPF 45 Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10% CARNAUBA WAX DIBUTYL ADIPATE SILICA DIMETHYL SILYLATE GLYCERIN OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE WATER CETOSTEARYL ALCOHOL SODIUM STEAROYL GLUTAMATE POLYGLYCERYL-6 ISOSTEARATE BUTYLOCTYL SALICYLATE DIETHYLHEXYL SYRINGYLIDENEMALONATE ETHYLHEXYLGLYCERIN PHENOXYETHANOL XANTHAN GUM DISODIUM EDTA-COPPER CETYL ALCOHOL SODIUM ASCORBYL PHOSPHATE TITANIUM DIOXIDE BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE ALCOHOL ETHYLHEXYLGLYCERYL BEHENATE HYDROXYACETOPHENONE BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER GLYCERYL STEARATE SE STARCH, TAPIOCA ALKYL (C12-15) BENZOATE TOCOPHEROL DOCOSANOL AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE (White to Off-White)
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 ® Oil Free + Shine Control Face 45 Blends Clear On All Skin Tones Won't Clog Pores Free of Oxybenzone, Octinoxate, PABA & Phthalates Water Resistant (40 Minutes) Broad Spectrum SPF 45 oil free shine control
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
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
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 Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
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