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Apostrophe screen spf43 - Medication Information

Product NDC Code 81780-007
Drug Name

Apostrophe screen spf43

Type Brand
Pharm Class Copper Absorption Inhibitor [EPC],
Decreased Copper Ion Absorption [PE]
Active Ingredients
Octinoxate 75 g/1000g
Octisalate 25 g/1000g
Zinc oxide 75 g/1000g
Route TOPICAL
Dosage Form LOTION
Application Number M020
Labeler Name Yoderm, Inc.
Packages
Package NDC Code Description
81780-007-02 2 g in 1 packet (81780-007-02)
81780-007-03 1 tube in 1 carton (81780-007-03) / 87 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Zinc Oxide 7.5% Sunscreen Octinoxate 7.5% Sunscreen Octisalate 2.5% Sunscreen

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. Use a water-resistant sunscreen if swimming or sweating. Reapply 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients purified water, isopropyl palmitate, ethylhexyl stearate, ethylhexyl isononanoate, cyclopentasiloxane, dimethicone, cetearyl glucoside, glycereth-26, phenoxyethanol, oleth-3 phosphate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, allantoin, polyisobutene, polyether-1, panthenol, butylene glycol, PEG-7 trimethylolpropane coconut ether, sodium hyaluronate, tocopheryl acetate, iodopropynyl butylcarbamate, ascorbyl palmitate, triethoxycaprylylsilane

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 measure (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.
Uses Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Spl product data elements

Usually a list of ingredients in a drug product.
Apostrophe Screen SPF43 Sunscreen OCTISALATE OCTISALATE OCTINOXATE OCTINOXATE ZINC OXIDE ZINC CATION WATER ISOPROPYL PALMITATE ETHYLHEXYL STEARATE ETHYLHEXYL ISONONANOATE CYCLOMETHICONE 5 DIMETHICONE CETEARYL GLUCOSIDE GLYCERETH-26 PHENOXYETHANOL OLETH-3 PHOSPHATE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) ALLANTOIN POLYISOBUTYLENE (1000 MW) PANTHENOL BUTYLENE GLYCOL HYALURONIC ACID .ALPHA.-TOCOPHEROL ACETATE IODOPROPYNYL BUTYLCARBAMATE ASCORBYL PALMITATE TRIETHOXYCAPRYLYLSILANE

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.
Labeling Apostrophe UC

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 KEEP OUT OF REACH OF CHILDREN

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.

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 physician if rash occurs. 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