KLENSKIN BROAD SPECTRUM SPF-50- avobenzone, octocrylene, octinoxate lotion

KLENSKIN BROAD SPECTRUM by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENTS

AVOBENZONE 2.1%

OCTINOXATE 5%

OCTOCRYLENE 5.4%

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 INGREDIENTS

Water (Aqua), Caprylic/Capric Triglyceride, Acrylates Copolymer, Dimethicone, Vinyldimethyl/Trimethylsiloxysilicate/Dimethicone Crosspolymer, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Polysorbate 20, Sorbitan Monooleate, Cocodimonium Hydroxypropyl Hydrolyzed Keratin, Butyrospermum Parkii (Shea) Oil, Polyamide 3, Carboxymethylcellulose Na,
Ethylenediamine/Stearyl Dimer Dilinoleate Copolymer, PG Hydroxyethylcellulose Stearyldimonium Chloride, Sodium Lauryl Glucose Carboxylate, Lauryl Glucoside, Laurdimoniumhydroxypropyl Decylglucosides Chloride, Gellan Gum, Sodium Alginate, Carrageenan, Tocopheryl Acetate, Rubeus Idaeus (Red Raspberry) Oil, Punica Granatum (Pomegranate) Seed Oil, Camellia Oleifera (Organic Green Tea) Seed Oil, Arctium Lappa Root Extract (Burdock Root), Phenoxyethanol, Trimethoxybenzylidene Pentanedione, Caprylyl Glycol

QUESTIONS

QUESTIONS OR COMMENTS? PLEASE CALL TOLL FREE 888.878.5536

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KLENSKIN BROAD SPECTRUM  SPF-50
avobenzone, octocrylene, octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61369-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.1 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5.4 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
DIMETHICONE (UNII: 92RU3N3Y1O)
VINYLDIMETHYL/TRIMETHYLSILOXYSILICATE STEARYL DIMETHICONE CROSSPOLYMER (UNII: 01S784FLCO)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
SHEANUT OIL (UNII: O88E196QRF)
POLYAMIDE-3 (12000 MW) (UNII: L7P3YWF22X)
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)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
LAURDIMONIUMHYDROXYPROPYL DECYLGLUCOSIDE CHLORIDE (UNII: GCO3569D5L)
GELLAN GUM (LOW ACYL) (UNII: 7593U09I4D)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
CARRAGEENAN (UNII: 5C69YCD2YJ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
RASPBERRY SEED OIL (UNII: 9S8867952A)
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIMETHOXYBENZYLIDENE PENTANEDIONE (UNII: 322V0ACF25)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61369-201-12	56 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2016
2	NDC: 61369-201-14	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/27/2016
3	NDC: 61369-201-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/16/2016

Labeler - CoLabs Intl. Corp (829850879)