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

KLENSKIN KIDS SHOWERON SUNSCREEN by

Drug Labeling and Warnings

KLENSKIN KIDS SHOWERON SUNSCREEN 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, 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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61369-102
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61369-102-18	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)