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

KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) GEL [COLABS INTL. CORP]
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NDC 61369-102-18
Set ID 2e394662-dd0a-4d0d-b4b0-568ecf7e2555
Category HUMAN OTC DRUG LABEL
Packager CoLabs Intl. Corp
Generic Name
Product Class
Product Number
Application Number PART352
  • 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, DISODIUM LAURETH SULFOSUCCINATE, COCAMIDOPROPYL BETAINE, SODIUM COCOYL ISETHIONATE, SODIUM METHYL COCOYL TAURATE, POLYSORBATE 20, PEG-150 PENTAERYTHRITYL TETRASTEARATE, GLYCERIN, SORBITAN MONOOLEATE, COCODIMONIUM HYDROXYPROPYL HYDROLYZED KERATIN, BUTYROSPERMUM PARKII (SHEA) OIL, DIMETHICONE, POLYAMIDE-3, PEG-6 CAPRYLIC/CAPRIC GLYCERIDES, SORBITAN STEARATE, CARBOXYMETHYCELLULOSE NA, ETHYLENEDIAMNE/STEARYL DIMER DILINOLEATE COPOLYMER, PG HYDROXYETHYLCELLULOSE STEARYLDIMONIUM CHLORIDE, SODIUM LAURYL GLUCOSE CARBOXYLATE, POLYQUATERNIUM 10, PHENOXYETHANOL, FRAGRANCE, CAPRYLYL GLYCOL, TETRASODIUM EDTA, LAURDIMONIUMHYDROXYPROPYL DECYLGLUCOSIDES CHLORIDE, LAURYL GLUCOSIDE, GELLAN GUM, SODIUM ALGINATE, ACRYLATES/C12-22 ALKYL METHACRYLATE COPOLYMER, 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, CARRAGEENAN, CITRIC ACID, SODIUM CHLORIDE

  • QUESTIONS

    QUESTIONS OR COMMENTS? PLEASE CALL TOLL FREE 888.878.5536

  • PRINCIPAL DISPLAY PANEL

    1-Label_Klenskin Kids

  • INGREDIENTS AND APPEARANCE
    KLENSKIN KIDS SHOWERON SUNSCREEN   SPF-30
    avobenzone, octocrylene, octinoxate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61369-102
    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)  
    LAURYL SULFOSUCCINATE (UNII: L81TQ3126P)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW) (UNII: ZR28QKN0WT)  
    SHEANUT OIL (UNII: O88E196QRF)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    ETHYLENEDIAMINE (UNII: 60V9STC53F)  
    DIISOSTEARYL DIMER DILINOLEATE (UNII: 04P17590AP)  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    SODIUM LAURYL GLYCOL CARBOXYLATE (UNII: 8L0472VMYL)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    GELLAN GUM (LOW ACYL) (UNII: 7593U09I4D)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61369-102-18236 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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