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Product NDC Code | 66800-0079 | ||||||||
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Drug Name | Coppertone protect and tan sunscreen spf 45 |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | LOTION | ||||||||
Application Number | part352 | ||||||||
Labeler Name | Beiersdort Inc | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, butyloctyl salicylate, neopentyl glycol diheptanoate, butylene glycol, styrene/acrylates copolymer, arachidyl alcohol, behenyl alcohol, dihydroxyacetone, acrylates/C12-22 alkyl methacrylate copolymer, 1,2-hexanediol, sodium stearoyl glutamate, arachidyl glucoside, erythrulose, hydroxyacetophenone, tocopherol, fragrance, pentylene glycol, caramel
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 Protect and Tan Sunscreen SPF 45 Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10% CARAMEL ALLYL METHACRYLATE OCTOCRYLENE OCTOCRYLENE OCTISALATE OCTISALATE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE WATER L-ERYTHRULOSE DOCOSANOL DIHYDROXYACETONE STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) SODIUM STEAROYL GLUTAMATE FRAGRANCE FRESH CITRUS FLORAL ORC1501495 ARACHIDYL ALCOHOL HYDROXYACETOPHENONE BUTYLENE GLYCOL BUTYLOCTYL SALICYLATE NEOPENTYL GLYCOL DIHEPTANOATE PENTYLENE GLYCOL ARACHIDYL GLUCOSIDE 1,2-HEXANEDIOL TOCOPHEROL 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® Sunscreen + Self Tanner Glow Protect & Tan 45 UVA/UVB Protection + Gradual Tanner Free of Oxybenzone, Octinoxate, Dyes & PABA Water Resistant (80 Minutes) Broad Spectrum SPF 45 5 FL OZ (148 mL) Glow PandT SPF45
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
Use ■ helps prevent sunburn
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