Label: KLENSKIN SHOWERON SUNSCREEN SPF-30- avobenzone, octocrylene, octinoxate gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 15, 2021

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    AVOBENZONE 2.75%

    OCTOCRYLENE 7.04%

    OCTINOXATE 7.2%

  • 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.
  • 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.

  • 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

  • QUESTIONS

    QUESTIONS OR COMMENTS? PLEASE CALL TOLL FREE 888.878.5536

  • PRINCIPAL DISPLAY PANEL

    8oz-klenskin_EXP_LBL

  • INGREDIENTS AND APPEARANCE
    KLENSKIN SHOWERON SUNSCREEN   SPF-30
    avobenzone, octocrylene, octinoxate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61369-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.75 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.04 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 BOVINE ELASTIN (BASE; 1000 MW) (UNII: ZR28QKN0WT)  
    SHEANUT OIL (UNII: O88E196QRF)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    DILINOLEIC ACID/ETHYLENEDIAMINE COPOLYMER (UNII: OC72DYI76F)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61369-101-18236 mL in 1 BOTTLE; Type 0: Not a Combination Product07/28/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/28/2014
    Labeler - CoLabs Intl. Corp (829850879)