KLENSKIN SHOWERON SUNSCREEN SPA SPF-30- avobenzone, octocrylene, octinoxate gel

KLENSKIN SHOWERON SUNSCREEN SPA by

Drug Labeling and Warnings

KLENSKIN SHOWERON SUNSCREEN SPA by is a Otc medication manufactured, distributed, or labeled by CoLabs Intl. Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

KLENSKIN SHOWERON SUNSCREEN SPA  SPF-30
avobenzone, octocrylene, octinoxate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61369-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.75 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.04 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61369-103-18	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/28/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/28/2014

Labeler - CoLabs Intl. Corp (829850879)