Klenskin Showeron Sunscreen
FDA Label NDC 61369-101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Colabs Intl. Corp for the product Klenskin Showeron Sunscreen (NDC 61369-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, otc - stop use, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENTS

AVOBENZONE 2.75%

OCTOCRYLENE 7.04%

OCTINOXATE 7.2%

Otc - Purpose

PURPOSE

SUNSCREEN

Indications & Usage

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.

Warnings

WARNINGS

  • FOR EXTERNAL USE ONLY
  • DO NOT USE ON DAMAGED OR BROKEN SKIN.
  • WHEN USING THIS PRODUCT, KEEP OUT OF EYES AND RINSE WITH EXCESSIVE WATER TO REMOVE.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Otc - Stop Use

STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS.

Dosage & Administration

DIRECTIONS

  • SHAKE WELL BEFORE USE
  • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE
  • REAPPLY:
  • AFTER 80 MINUTES OF SWIMMING, SWEATING OR EXPOSURE TO WATER
  • IMMEDIATELY AFTER TOWEL DRYING
  • AT LEAST EVERY 2 HOURS

Other Safety Information

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 A.M. - 2 P.M.
  • WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES
  • CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

    • OTHER INFORMATION

    • PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUNLIGHT.

Inactive Ingredient

INACTIVE INGREDIENTS

WATER, SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, COCAMIDOPROPYL BETAINE, POLYSORBATE 20, GLYCERIN, POLYQUATERNIUM-10, SORBITAN MONOOLEATE, COCODIMONIUM HYDROXYPROPYL HYDROLYZED KERATIN, BUTYROSPERMUM PARKII (SHEA) OIL, DIMETHICONE, POLYAMIDE-3, SORBITAN STEARATE, CARBOXYMETHYCELLULOSE NA, ETHYLENEDIAMINE/STEARYL DIMER DILINOLEATE COPOLYMER, PG HYDROXYETHYLCELLULOSE STEARDIMONIUM CHLORIDE, SODIUM LAURYL GLUCOSE CARBOXYLATE, PHENOXYETHANOL, ACRYLATES/C12-22 ALKYL METHACRYLATE COPOLYMER, CAPRYLYL GLYCOL, TETRASODIUM EDTA, LAURYLDIMONIUMHYDROXYPROPYL DECYLGLUCOSIDES CHLORIDE, GELLAN GUM, SODIUM ALGINATE, ARCTIUM LAPPA (BURDOCK ROOT) EXTRACT, LAURYL GLUCOSIDE, CAMELIA OLEIFERA (GREEN TEA) SEED OIL, PUNICA GRANATUM (POMEGRANATE) SEED OIL, RUBEUS IDAEUS (RED RASPBERRY) OIL, VACCINIUM MACROCARPON (CRANBERRY) SEED OIL, VITIS VINIFERA (GRAPE) SEED OIL, CARRAGEENAN, CITRIC ACID, SODIUM CHLORIDE

Otc - Questions

QUESTIONS OR COMMENTS? PLEASE CALL TOLL FREE 888.878.5536

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