KLENSKIN BROAD SPECTRUM SUNSCREEN SPF-30 (AVOBENZONE, HOMOSALATE, OCTISALATE) STICK [COLABS INTL. CORP]

KLENSKIN BROAD SPECTRUM SUNSCREEN SPF-30 (AVOBENZONE, HOMOSALATE, OCTISALATE) STICK [COLABS INTL. CORP]
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NDC 61369-105-11
Set ID da53cae0-ffe6-4596-94be-78b4d4e4aeab
Category HUMAN OTC DRUG LABEL
Packager CoLabs Intl. Corp
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENTS

    AVOBENZONE 2.3%

    HOMOSALATE 9.2%

    OCTISALATE 4.3%

  • PURPOSE

    SUNSCREEN

  • USES

    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 EXPOSURE TO SUNLIGHT.
  • INACTIVE INGREDIENTS

    CERA ALBA (BEESWAX), WATER, CAPRYLIC/CAPRIC TRIGLYCERIDE, BIS-PEG-METHYL ETHER DIMETHYL SILANE, POLYETHYLENE, THEOBROMA CACAO (COCOA) SEED BUTTER, BUTYROSPERMUM PARKII (SHEA) BUTTER, SORBITAN STEARATE, SORBITAN OLEATE, POLYSORBATE 20, TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER, OCTYLDECANOL, PHENOXYETHANOL, CAPRYLYL GLYCOL, TOCOPHERYL ACETATE, VACCINIUM MACROCARPON (CRANBERRY) SEED OIL, VITIS VINIFERA (GRAPE) SEED OIL, PUNICA GRANATUM (POMEGRANATE) SEED OIL, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, TRIMETHOXYBENZYLIDENE PENTANEDIONE, POLYAMIDE-3, ALGIN, CHITOSAN

  • QUESTIONS OR COMMENTS?

    PLEASE CALL TOLL FREE 888.878.5536

  • PRINCIPAL DISPLAY PANEL

    01b LBL_SPF-30 Sunscreen Stick_front

    01b LBL_SPF-30 Sunscreen Stick_back

  • INGREDIENTS AND APPEARANCE
    KLENSKIN BROAD SPECTRUM SUNSCREEN   SPF-30
    avobenzone, homosalate, octisalate stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61369-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9.2 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    TRIMETHOXYBENZYLIDENE PENTANEDIONE (UNII: 322V0ACF25)  
    POLYAMIDE-3 (12000 MW) (UNII: L7P3YWF22X)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    POLIGLUSAM (UNII: 82LKS4QV2Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61369-105-1114.2 g in 1 TUBE; Type 0: Not a Combination Product11/12/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/12/2018
    Labeler - CoLabs Intl. Corp (829850879)

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