KLENSKIN SPF LIP BALM BROAD SPECTRUM SPF-50 (ALL FLAVORS)- avobenzone, homosalate, octisalate lipstick

KLENSKIN SPF LIP BALM BROAD SPECTRUM by

Drug Labeling and Warnings

KLENSKIN SPF LIP BALM 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 2.3%

Homosalate 9.2%

Octisalate 4.3%

PURPOSE

SUNSCREEN

USES

• Helps prevent sunburn
• If used as directed with othersun protection measures (see Directions), decreases therisk of skin cancer and early skin aging caused by the sun.

WARNINGS

• For external use only
• Do not use ondamaged or broken skin. When using this product, keepout 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.

DIRECTIONS

Apply liberally 15 minutes before sun exposure

• Reapply: At least every 2 hours

OTHER INFORMATION

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 sunglasses Children under 6 months: Ask a doctor.

Protect this product from excessive heat & direct sunlight.

INACTIVE INGREDIENTS

Cera Alba (Beeswax), Caprylic/Capric Triglyceride, Water, Polyethylene, Theobroma Cacao (Cocoa) Seed Butter, Bis-PEG-18 Methyl Ether Dimethyl Silane, Flavor, Butyrospermum parkii (Shea) Butter, Sorbitan Stearate, Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Octyldecanol, Trimethoxybenzylidene Pentanedione, Stevia Rebaudiana Leaf Extact, Sodium Saccharin, Tocopheryl Acetate, Vaccinium Macrocarpon (Cranberry) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Punica Granatum (Pomegranate) Seed Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Chitosan, Algin, Phenoxyethanol, Ethylhexylglycerin

QUESTIONS OR COMMENTS?

PLEASE CALL TOLL FREE 888.878.5536

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KLENSKIN SPF LIP BALM BROAD SPECTRUM  SPF-50 (ALL FLAVORS)
avobenzone, homosalate, octisalate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61369-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9.2 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
COCOA BUTTER (UNII: 512OYT1CRR)
BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C)
SHEA BUTTER (UNII: K49155WL9Y)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)
OCTYLDODECANOL (UNII: 461N1O614Y)
TRIMETHOXYBENZYLIDENE PENTANEDIONE (UNII: 322V0ACF25)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
GRAPE SEED OIL (UNII: 930MLC8XGG)
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
TEA TREE OIL (UNII: VIF565UC2G)
CHITOSAN HIGH MOLECULAR WEIGHT (400-800 MPA.S) (UNII: 7SRJ3W89J8)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61369-301-23	4.25 g in 1 TUBE; Type 0: Not a Combination Product	08/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/15/2018

Labeler - CoLabs Intl. Corp (829850879)