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Avobenzone, homosalate, octisalate - Medication Information

Product NDC Code 79481-0932
Drug Name

Avobenzone, homosalate, octisalate

Type Generic
Active Ingredients
Avobenzone 30 mg/ml
Homosalate 100 mg/ml
Octisalate 50 mg/ml
Route TOPICAL
Dosage Form LOTION
Application Number M020
Labeler Name Meijer Distribution, Inc
Packages
Package NDC Code Description
79481-0932-1 88 ml in 1 tube (79481-0932-1)
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Adverse reactions

Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.
Adverse Reactions Questions 1-888-593-0593 DIST. BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544 www.meijer.com OUR QUALITY GUARANTEE The Meijer Family www.meijer.com/satisfaction how2recycle.info

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Avobenzone 3% Homosalate 10% Octisalate 5%

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 liberaly 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especialy 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, diethylhexyl 2, 6-naphthalate, silica, butyloctyl salicylate, caprylyl methicone, dimethicone, potassium cetyl phosphate, benzyl alcohol, beeswax, glyceryl stearate, PEG-100 stearate, cetyl dimethicone, glycerin, behenyl alcohol, sodium polyacrylate, acrylates/C12-22 alkyl methacrylate copolymer, xanthan gum, chlorphenesin, dimethicone/PEG-10/15 crosspolymer, ethylhexyl stearate, fragrance, disodium EDTA, tocopheryl acetate, BHT, trideceth-6, pentylene glycol, benzyl benzoate

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.
Avobenzone, Homosalate, Octisalate Avobenzone, Homosalate, Octisalate WATER DIETHYLHEXYL 2,6-NAPHTHALATE SILICON DIOXIDE BUTYLOCTYL SALICYLATE CAPRYLYL TRISILOXANE DIMETHICONE POTASSIUM CETYL PHOSPHATE BENZYL ALCOHOL YELLOW WAX GLYCERYL MONOSTEARATE PEG-100 STEARATE CETYL DIMETHICONE 150 GLYCERIN DOCOSANOL SODIUM POLYACRYLATE (8000 MW) BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER XANTHAN GUM CHLORPHENESIN DIMETHICONE/PEG-10/15 CROSSPOLYMER ETHYLHEXYL STEARATE EDETATE DISODIUM ANHYDROUS .ALPHA.-TOCOPHEROL ACETATE BUTYLATED HYDROXYTOLUENE TRIDECETH-6 PENTYLENE GLYCOL BENZYL BENZOATE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE

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 meijer sheer touch sunscreen lotion BROAD SPECTRUM SPF 30 UVA/UVB SUNSCREEN SPF 30 WATER RESISTANT (80 MINUTES) CLEAN, LIGHTWEIGHT FEEL DERMATOLOGIST TESTED OXYBENZONE, OCTINOXATE AND OCTOCRYLENE FREE COMPARE TO NEUTROGENA® ULTRA SHEER® SUNSCREEN BREAD SPECTRUM spf 30* 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.
Disclaimer *This product is not manufacturedor distributed by Johnson & Johnson Corporation., distributor of Neutrogena Ultra Sheer Dry-Touch Sunscreen Broad Spectrum SPF 30. May stain or damage some fabrics or surfaces.

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 right away.

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.

Storage and handling

Information about safe storage and handling of the drug product.
Other information protect the product in this container from excessive heat and direct sun

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