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Replenix sunscreen spf 50 - Medication Information

Product NDC Code 51326-220
Drug Name

Replenix sunscreen spf 50

Type Brand
Active Ingredients
Octinoxate 75 mg/g
Zinc oxide 145 mg/g
Route TOPICAL
Dosage Form LOTION
Application Number M020
Labeler Name Topiderm, Inc.
Packages
Package NDC Code Description
51326-220-01 63 g in 1 bottle (51326-220-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Purpose Zinc Oxide 14.5% Sunscreen Octinoxate 7.5% Sunscreen
Active ingredientPurpose
Zinc Oxide 14.5%Sunscreen
Octinoxate 7.5%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 to face and neck and spread evenly 15 minutes before sun exposure Re-apply after swimming, excessive perspiring, or anytime after towel drying Use a water resistant sunscreen if swimming or sweating Use on children under 6 months of age: consult a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Purified Water, Niacinamide, Oleth-3 Phosphate, Neopentyl Glycol Diheptanoate, Polyisobutene, Octyldodecyl Neopentanoate, Butylene Glycol, Tocopheryl Acetate, Sodium Hyaluronate, Caffeine, Panthenol, Dimethicone, Sucrose, Lactic Acid, Glycerin, Ethylhexyl Stearate, Triethoxycaprylylsilane, Xanthan Gum, Lauryl PEG Polydimethylsiloxyethyl Dimethicone, PEG-7 Trimethylolpropane Coconut Ether, Hydroxyethyl Acrylate/Sodium Acryloydimethyl Taurate Copolymer, Phenoxyethanol, Disodium EDTA.

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.
Active ingredient Purpose Zinc Oxide 14.5% Sunscreen Octinoxate 7.5% Sunscreen
Active ingredientPurpose
Zinc Oxide 14.5%Sunscreen
Octinoxate 7.5%Sunscreen

Spl product data elements

Usually a list of ingredients in a drug product.
Replenix Sunscreen SPF 50 ZINC OXIDE ZINC OXIDE ZINC OXIDE OCTINOXATE OCTINOXATE WATER NIACINAMIDE OLETH-3 PHOSPHATE NEOPENTYL GLYCOL DIHEPTANOATE OCTYLDODECYL NEOPENTANOATE BUTYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE HYALURONATE SODIUM CAFFEINE PANTHENOL DIMETHICONE SUCROSE LACTIC ACID, DL- GLYCERIN ETHYLHEXYL STEARATE TRIETHOXYCAPRYLYLSILANE XANTHAN GUM PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER PHENOXYETHANOL EDETATE DISODIUM

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 - 63 g Bottle Label REPLENiX ® SUNSCREEN ESSENTIAL OIL FREE SHEER SPF 50 14.5% Micronized Zinc Oxide Multi-tasking sheer application Sensitive skin friendly BROAD SPECTRUM UVA/UVB SPF 50 Net wt. 2.22 oz. (63 g) TOPIX PHARMACEUTICALS, INC. N. AMITYVILLE, NY 11701 PRINCIPAL DISPLAY PANEL - 63 g Bottle Label

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

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. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

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 if signs of irritation or rash appear. If irritation or rash persists consult a doctor.

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. When using this product keep out of eyes, rinse with water to remove. Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. 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 sunscreen measures including: limit time in the sun, especially from 10 a.m.-2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses

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