Label: KLENSKIN BROAD SPECTRUM SPF-50- avobenzone, octocrylene, octinoxate lotion

  • NDC Code(s): 61369-201-12, 61369-201-14, 61369-201-32
  • Packager: CoLabs Intl. Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 15, 2024

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  • ACTIVE INGREDIENTS

    AVOBENZONE 2.1%

    OCTINOXATE 5%

    OCTOCRYLENE 5.4%

  • 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 INGREDIENTS

    Water (Aqua), Caprylic/Capric Triglyceride, Acrylates Copolymer, Dimethicone, Vinyldimethyl/Trimethylsiloxysilicate/Dimethicone Crosspolymer, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Polysorbate 20, Sorbitan Monooleate, Cocodimonium Hydroxypropyl Hydrolyzed Keratin, Butyrospermum Parkii (Shea) Oil, Polyamide 3, Carboxymethylcellulose Na,
    Ethylenediamine/Stearyl Dimer Dilinoleate Copolymer, PG Hydroxyethylcellulose Stearyldimonium Chloride, Sodium Lauryl Glucose Carboxylate, Lauryl Glucoside, Laurdimoniumhydroxypropyl Decylglucosides Chloride, Gellan Gum, Sodium Alginate, Carrageenan, Tocopheryl Acetate, Rubeus Idaeus (Red Raspberry) Oil, Punica Granatum (Pomegranate) Seed Oil, Camellia Oleifera (Organic Green Tea) Seed Oil, Arctium Lappa Root Extract (Burdock Root), Phenoxyethanol, Trimethoxybenzylidene Pentanedione, Caprylyl Glycol

  • QUESTIONS

    QUESTIONS OR COMMENTS? PLEASE CALL TOLL FREE 888.878.5536

  • PRINCIPAL DISPLAY PANEL

    KLENSKIN_4oz_SPF50_Lotion_final v6

  • INGREDIENTS AND APPEARANCE
    KLENSKIN BROAD SPECTRUM  SPF-50
    avobenzone, octocrylene, octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61369-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.1 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5.4 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    VINYLDIMETHYL/TRIMETHYLSILOXYSILICATE STEARYL DIMETHICONE CROSSPOLYMER (UNII: 01S784FLCO)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    SHEANUT OIL (UNII: O88E196QRF)  
    POLYAMIDE-3 (12000 MW) (UNII: L7P3YWF22X)  
    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)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    LAURDIMONIUMHYDROXYPROPYL DECYLGLUCOSIDE CHLORIDE (UNII: GCO3569D5L)  
    GELLAN GUM (LOW ACYL) (UNII: 7593U09I4D)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
    CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TRIMETHOXYBENZYLIDENE PENTANEDIONE (UNII: 322V0ACF25)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61369-201-1256 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2016
    2NDC:61369-201-14118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/27/2016
    3NDC:61369-201-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/16/2016
    Labeler - CoLabs Intl. Corp (829850879)
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