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Sunscreen - Medication Information

Product NDC Code 11822-1914
Drug Name

Sunscreen

Type Brand
Active Ingredients
Avobenzone 30 mg/ml
Homosalate 100 mg/ml
Octisalate 50 mg/ml
Octocrylene 60 mg/ml
Route TOPICAL
Dosage Form LOTION
Application Number part352
Labeler Name Rite Aid
Packages
Package NDC Code Description
11822-1914-2 88 ml in 1 tube (11822-1914-2)
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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 6 %

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, silica, dimethicone, potassium cetyl phosphate, benzyl alcohol, beeswax, glyceryl stearate, PEG-100 stearate, caprylyl methicone, cetyl dimethicone, dimethicone/PEG-10/15 crosspolymer, sodium polyacrylate, behenyl alcohol, xanthan gum, glycerin, pentylene glycol, acrylates/C12-22 alkyl methacrylate copolymer, ethylhexyl stearate, chlorphenesin, disodium EDTA, fragrance, diethylhexyl 2,6-naphthalate, BHT, trideceth-6

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.
Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene AVOBENZONE AVOBENZONE Homosalate HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE WATER SILICON DIOXIDE DIMETHICONE POTASSIUM CETYL PHOSPHATE BENZYL ALCOHOL YELLOW WAX GLYCERYL MONOSTEARATE PEG-100 STEARATE CAPRYLYL TRISILOXANE CETYL DIMETHICONE 150 DIMETHICONE/PEG-10/15 CROSSPOLYMER SODIUM POLYACRYLATE (8000 MW) DOCOSANOL xanthan gum GLYCERIN PENTYLENE GLYCOL ALLYL METHACRYLATE ethylhexyl stearate CHLORPHENESIN EDETATE DISODIUM ANHYDROUS diethylhexyl 2,6-naphthalate BUTYLATED HYDROXYTOLUENE TRIDECETH-6

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 daylogic FREE FROM OXYBENZONE - PHTHALATES sheer touch SUNSCREEN LOTION BROAD SPECTRUM SPF 30 UVA/UVB Protection Water Resistant (80 minutes) Non-greasy Clean & Lightweight Feel COMPARE TO NEUTROGENA ULTRA SHEER SUNSCREEN BROAD SPECTRUM SPF 30* 3 FL OZ (88 mL) image description principal display panel SHEER TOUCH SUNSCREEN SUNSCREEN LOTION 30 BROAD SPECTRUM SPF 30 WATER RESISTANT RYSHI WATER RESISTANT UP TO 80 MINUTES QUICKLY ABSORVED COMPARE TO NEUTROGENA ULTRA SHEER SUNSCREEN 3FL 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.
May stain or damage some fabrics or surfaces. DISTRIBUTED BY: RITE AID 30 HUNTER LANE CAMP HILL, PA 17011 www.riteaid.com SATISFACTION GUARANTEE: If you're not satisifed, We'll happily refund your money. This product is not manufacturedor distributed by Johnson & Johnson Consumer Inc., distributor of Neutrogena Ultra Sheer Dry-Touch Sunscreen Broad Spectrum SPF 30.

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.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information protect the product in this container from excessive heat and direct sun

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