Drug Labeling and Warnings

Drug Details

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KLENSKIN SHOWERON SUNSCREEN SPA SPF-30- avobenzone, octocrylene, octinoxate gel 
CoLabs Intl. Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENTS

AVOBENZONE 2.75%

OCTOCRYLENE 7.04%

OCTINOXATE 7.2%

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. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS.

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

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, 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 OR COMMENTS? PLEASE CALL TOLL FREE 888.878.5536

1-Label_Klenskin Spa 2015-03-05

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 Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/28/2014
Labeler - CoLabs Intl. Corp (829850879)

Revised: 4/2015
 
CoLabs Intl. Corp


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