KLENSKIN BROAD SPECTRUM SUNSCREEN SPF-30- avobenzone, homosalate, octisalate stick

KLENSKIN BROAD SPECTRUM SUNSCREEN by

Drug Labeling and Warnings

KLENSKIN BROAD SPECTRUM SUNSCREEN 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

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

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:
• 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 EXPOSURE TO SUNLIGHT.

INACTIVE INGREDIENTS

CERA ALBA (BEESWAX), WATER, CAPRYLIC/CAPRIC TRIGLYCERIDE, BIS-PEG-METHYL ETHER DIMETHYL SILANE, POLYETHYLENE, THEOBROMA CACAO (COCOA) SEED BUTTER, BUTYROSPERMUM PARKII (SHEA) BUTTER, SORBITAN STEARATE, SORBITAN OLEATE, POLYSORBATE 20, TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER, OCTYLDECANOL, PHENOXYETHANOL, CAPRYLYL GLYCOL, TOCOPHERYL ACETATE, VACCINIUM MACROCARPON (CRANBERRY) SEED OIL, VITIS VINIFERA (GRAPE) SEED OIL, PUNICA GRANATUM (POMEGRANATE) SEED OIL, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, TRIMETHOXYBENZYLIDENE PENTANEDIONE, POLYAMIDE-3, ALGIN, CHITOSAN

QUESTIONS OR COMMENTS?

PLEASE CALL TOLL FREE 888.878.5536

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KLENSKIN BROAD SPECTRUM SUNSCREEN  SPF-30
avobenzone, homosalate, octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61369-105
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)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
COCOA BUTTER (UNII: 512OYT1CRR)
SHEA BUTTER (UNII: K49155WL9Y)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.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)
TRIMETHOXYBENZYLIDENE PENTANEDIONE (UNII: 322V0ACF25)
POLYAMIDE-3 (12000 MW) (UNII: L7P3YWF22X)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
POLIGLUSAM (UNII: 82LKS4QV2Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61369-105-11	14.2 g in 1 TUBE; Type 0: Not a Combination Product	11/12/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/12/2018

Labeler - CoLabs Intl. Corp (829850879)