KLENSKIN SPF LIP BALM BROAD SPECTRUM SPF-50 (ALL FLAVORS) (AVOBENZONE, HOMOSALATE, OCTISALATE) LIPSTICK [COLABS INTL. CORP]

KLENSKIN SPF LIP BALM BROAD SPECTRUM SPF-50 (ALL FLAVORS) (AVOBENZONE, HOMOSALATE, OCTISALATE) LIPSTICK [COLABS INTL. CORP]
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NDC 61369-301-23
Set ID 118fd112-4085-4a76-bb64-46c57b3a6377
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

    • Helps prevent sunburn
    • If used as directed with othersun protection measures (see Directions), decreases therisk of skin cancer and early skin aging caused by the sun.
  • WARNINGS

    • For external use only
    • Do not use ondamaged or broken skin. When using this product, keepout 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: • At least every 2 hours
  • OTHER INFORMATION

    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 10a.m.-2p.m. • Wear long-sleeve shirts, pants, hats, and sunglasses • Children under 6 months: Ask a doctor.

    • Protect this product from excessive heat & direct sunlight.

  • INACTIVE INGREDIENTS

    Cera Alba (Beeswax), Caprylic/Capric Triglyceride, Water, Polyethylene, Theobroma Cacao (Cocoa) Seed Butter, Bis-PEG-18 Methyl Ether Dimethyl Silane, Flavor, Butyrospermum parkii (Shea) Butter, Sorbitan Stearate, Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Octyldecanol, Trimethoxybenzylidene Pentanedione, Stevia Rebaudiana Leaf Extact, Sodium Saccharin, Tocopheryl Acetate, Vaccinium Macrocarpon (Cranberry) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Punica Granatum (Pomegranate) Seed Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Chitosan, Algin, Phenoxyethanol, Ethylhexylglycerin

  • QUESTIONS OR COMMENTS?

    PLEASE CALL TOLL FREE 888.878.5536

  • PRINCIPAL DISPLAY PANEL

    KLENSKIN_2_1875x3_9688_CHERRY

  • INGREDIENTS AND APPEARANCE
    KLENSKIN SPF LIP BALM BROAD SPECTRUM   SPF-50 (ALL FLAVORS)
    avobenzone, homosalate, octisalate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61369-301
    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)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    WATER (UNII: 059QF0KO0R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    TRIMETHOXYBENZYLIDENE PENTANEDIONE (UNII: 322V0ACF25)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    .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)  
    CHITOSAN HIGH MOLECULAR WEIGHT (400-800 MPA.S) (UNII: 7SRJ3W89J8)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61369-301-234.25 g in 1 TUBE; Type 0: Not a Combination Product08/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/15/2018
    Labeler - CoLabs Intl. Corp (829850879)

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