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Kelsen - spf 30 daily sunscreen - Medication Information

Product NDC Code 82626-101
Drug Name

Kelsen - spf 30 daily sunscreen

Type Brand
Active Ingredients
Zinc oxide 10 g/100ml
Route TOPICAL
Dosage Form LOTION
Application Number part352
Labeler Name KELSEN PRODUCTS INC
Packages
Package NDC Code Description
82626-101-11 60 ml in 1 tube (82626-101-11)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENT ZINC OXIDE 10%

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. CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR. 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 VALUE OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING: LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 A.M. - 2 P.M. WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENTS WATER, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIMETHICONE, BUTYLENE GLYCOL, CETEARYL ALCOHOL, CETEARYL OLIVATE, POLYGLYCERYL-3 DIISOSTEARATE, CETEARYL GLUCOSIDE, SORBITAN STEARATE, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, XANTHAN GUM, CAMELLIA SINENSIS (GREEN TEA) LEAF OIL, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, IRON OXIDES.

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.
USE HELPS PREVENT SUNBURN

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.
KELSEN - SPF 30 DAILY SUNSCREEN ZINC OXIDE SORBITAN OLIVATE FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE ETHYLHEXYLGLYCERIN WATER MEDIUM-CHAIN TRIGLYCERIDES DIMETHICONE BUTYLENE GLYCOL CETOSTEARYL ALCOHOL .ALPHA.-TOCOPHEROL ACETATE CETEARYL OLIVATE POLYGLYCERYL-3 DIISOSTEARATE CETEARYL GLUCOSIDE PHENOXYETHANOL XANTHAN GUM FERRIC OXIDE RED GREEN TEA LEAF TRIETHOXYCAPRYLYLSILANE ZINC OXIDE ZINC OXIDE

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.
KELSEN SPF 30 DAILY SUNSCREEN

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 CENTER RIGHT AWAY.

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. 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.

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