Label: KLENSKIN SUNSCREEN FACE AND BODY BROAD SPECTRUM SPF 30- homosalate, octisalate, zinc gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 15, 2024

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  • ACTIVE INGREDIENTS

    HOMOSALATE 9.75%

    OCTISALATE 5%

    ZINC 10.3%

  • PURPOSE

    SUNSCREEN

  • 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

    • 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.

  • DIRECTIONS

    • 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, Acrylates Copolymer, Caprylic/Capric Triglyceride, Diatomaceous Earth, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Phenoxyethanol, Ricinus Comminus (Castor) Seed Oil, Hydrogenated Castor Oil, Cetyl Dimethicone, Simmondsia Chinensis (Jojoba) Seed Oil, Rubeus Idaeus (Red Raspberry) Oil, Vitus Vinifera (Grape) Seed Oil, Tocopheryl Acetate, Cucumis Sativua (Cucumber) Seed Oil, Butyrospermum Parkii (Shea) Oil

  • QUESTIONS OR COMMENTS?

    PLEASE CALL TOLL FREE 888.878.5536

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Sunscreen Face-Body SPF30_3oz

  • INGREDIENTS AND APPEARANCE
    KLENSKIN SUNSCREEN FACE AND BODY BROAD SPECTRUM  SPF 30
    homosalate, octisalate, zinc gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61369-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9.75 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CUCUMBER SEED OIL (UNII: AKP926H71P)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    CETYL DIMETHICONE 45 (UNII: IK315POC44)  
    JOJOBA OIL (UNII: 724GKU717M)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61369-202-1388 mL in 1 TUBE; Type 0: Not a Combination Product11/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/24/2020
    Labeler - CoLabs Intl. Corp (829850879)
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