NDC 61369-101 Klenskin Showeron Sunscreen Spf-30

Avobenzone, Octocrylene, Octinoxate

NDC Product Code 61369-101

NDC 61369-101-18

Package Description: 236 mL in 1 BOTTLE

NDC Product Information

Klenskin Showeron Sunscreen Spf-30 with NDC 61369-101 is a a human over the counter drug product labeled by Colabs Intl. Corp. The generic name of Klenskin Showeron Sunscreen Spf-30 is avobenzone, octocrylene, octinoxate. The product's dosage form is gel and is administered via topical form.

Labeler Name: Colabs Intl. Corp

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Klenskin Showeron Sunscreen Spf-30 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • AVOBENZONE 2.75 g/100mL
  • OCTOCRYLENE 7.04 g/100mL
  • OCTINOXATE 7.2 g/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYQUATERNIUM-10 (125 MPA.S AT 2%) (UNII: L45WU8S981)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
  • HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW) (UNII: ZR28QKN0WT)
  • SHEANUT OIL (UNII: O88E196QRF)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • ETHYLENEDIAMINE (UNII: 60V9STC53F)
  • DIISOSTEARYL DIMER DILINOLEATE (UNII: 04P17590AP)
  • HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
  • DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
  • SODIUM LAURYL GLYCOL CARBOXYLATE (UNII: 8L0472VMYL)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • HYDROXYETHYL LAURDIMONIUM CHLORIDE (UNII: 8467K53E3Y)
  • GELLAN GUM (LOW ACYL) (UNII: 7593U09I4D)
  • SODIUM ALGINATE (UNII: C269C4G2ZQ)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
  • CAMELLIA OLEIFERA SEED (UNII: 59ED29FM2J)
  • POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
  • RASPBERRY SEED OIL (UNII: 9S8867952A)
  • CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • CARRAGEENAN (UNII: 5C69YCD2YJ)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Colabs Intl. Corp
Labeler Code: 61369
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-28-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Klenskin Showeron Sunscreen Spf-30 Product Label Images

Klenskin Showeron Sunscreen Spf-30 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

ACTIVE INGREDIENTSAVOBENZONE 2.75%OCTOCRYLENE 7.04%OCTINOXATE 7.2%

Otc - Purpose

PURPOSESUNSCREEN

Indications & Usage

  • USESHELPS PREVENT SUNBURNIF 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

  • WARNINGSFOR EXTERNAL USE ONLYDO 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

  • DIRECTIONSSHAKE WELL BEFORE USEAPPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSUREREAPPLY:AFTER 80 MINUTES OF SWIMMING, SWEATING OR EXPOSURE TO WATERIMMEDIATELY AFTER TOWEL DRYINGAT 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 SUNGLASSESCHILDREN UNDER 6 MONTHS: ASK A DOCTOR.OTHER INFORMATIONPROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUNLIGHT.

Inactive Ingredient

INACTIVE INGREDIENTSWATER, 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

* Please review the disclaimer below.