KLENSKIN SUNBAR by CoLabs Intl. Corp

KLENSKIN SUNBAR by

Drug Labeling and Warnings

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

Drug Details [pdf]

KLENSKIN SUNBAR SPF-20- octinoxate, octocrylene, avobenzone soap 
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

OCTOCRYLENE 5.20%

OCTINOXATE 4.20%

AVOBENZONE 1.60%

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

Apply liberally 15 minutes before sun exposure

• Reapply: At least every 2 hours

OTHER 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 10a.m.-2p.m.
Wear long-sleeve shirts,pants, hats, and sunglasse
Childrenunder 6 months: Ask a doctor.

OTHER INFORMATION

• PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUNLIGHT.

INACTIVE INGREDIENTS

Water, Propylene Glycol, Sodium Stearate, Glycerin, Sodium Laureth Sulfate, Sorbitol, Sodium Lauryl Sulfate, Sodium Myristate, Sodium Cocoyl Isethionate, Acrylates Copolymer, Polyquaternium-16, Triethanolamine, Polyamide-3, Sorbitan Monooleate, Polysorbate 20,
Titanium Dioxide (opacifier), Carboxymethylcellulose Na, Polyethylene Glycol-16, Silica, Tetrasodium Etidronate, Pentasodium
Pentetate, DMDM Hydantoin Iodopropynyl Butylcarbamate, PG-Hydroxyethylcellulose, Stearyldimonium Chloride, Cocodimonium Hydroxypropyl Hydrolyzed Keratin

QUESTIONS OR COMMENTS?

PLEASE CALL TOLL FREE 888.878.5536

WWW.KLENSKIN.COM

KLENSKIN SUNBAR  SPF-20
octinoxate, octocrylene, avobenzone soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61369-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.6 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM STEARATE (UNII: QU7E2XA9TG)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SORBITOL (UNII: 506T60A25R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM MYRISTATE (UNII: 06BLC4V0IV)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
POLYQUATERNIUM-16 (N-VINYLPYRROLIDINONE:3-METHYL-1-VINYLIMIDAZOLIUM CHLORIDE (5:5)) (UNII: 1KX12A42IJ)
TROLAMINE (UNII: 9O3K93S3TK)
POLYAMIDE-3 (20000 MW) (UNII: PLF06VZ9SQ)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
POLYETHYLENE GLYCOL 800 (UNII: UH6KR4953D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
EDETATE SODIUM (UNII: MP1J8420LU)
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)
DMDM HYDANTOIN (UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PROPYLENE GLYCOL-HYDROXYETHYLCELLULOSE STEARYLDIMONIUM CHLORIDE (UNII: 3479326GXB)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61369-104-23	100 g in 1 PACKAGE; Type 0: Not a Combination Product	03/17/2016	12/04/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/17/2016	12/04/2019

Labeler - CoLabs Intl. Corp (829850879)

Revised: 12/2019

Document Id: d0ea913f-2a12-40cb-91f9-623a0dfec154

34390-5

Set id: f1b2b228-b723-463d-ae9e-e5a970a6b734

Version: 6

Effective Time: 20191204