KLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]

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  • KLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]

KLENSKIN SHOWERON SUNSCREEN SPA SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]
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NDC 61369-103-18
Set ID e0bca93b-01ad-45d5-860a-d2a34d085dd9
Category HUMAN OTC DRUG LABEL
Packager CoLabs Intl. Corp
Generic Name
Product Class
Product Number
Application Number PART352
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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, FRAGRANCE, 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 CLORIDE, GELLAN GUM, SODIUM ALGINATE, LAURYL GLUCOSIDE, ARCTIUM LAPPA (BURDOCK ROOT) EXTRACT, 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

    1-Label_Klenskin Spa 2015-03-05

  • INGREDIENTS AND APPEARANCE
    KLENSKIN SHOWERON SUNSCREEN SPA   SPF-30
    avobenzone, octocrylene, octinoxate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61369-103
    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 ELASTIN, BOVINE, ALKALINE (1000 MW) (UNII: ZR28QKN0WT)  
    SHEANUT OIL (UNII: O88E196QRF)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    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)  
    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:61369-103-18236 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)
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