KLENSKIN SUNSCREEN FACE AND BODY BROAD SPECTRUM SPF 30- homosalate, octisalate, zinc gel

KLENSKIN SUNSCREEN FACE AND BODY BROAD SPECTRUM by

Drug Labeling and Warnings

KLENSKIN SUNSCREEN FACE AND BODY 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

HOMOSALATE 9.75%

OCTISALATE 5%

ZINC 10.3%

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

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 SUNLIGHT.

INACTIVE INGREDIENTS

Water, Acrylates Copolymer, Caprylic/Capric Triglyceride, Diatomaceous Earth, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Phenoxyethanol, Ricinus Comminus (Castor) Seed Oil, Hydrogenated Castor Oil, Cetyl Dimethicone, Simmondsia Chinensis (Jojoba) Seed Oil, Rubeus Idaeus (Red Raspberry) Oil, Vitus Vinifera (Grape) Seed Oil, Tocopheryl Acetate, Cucumis Sativua (Cucumber) Seed Oil, Butyrospermum Parkii (Shea) Oil

QUESTIONS OR COMMENTS?

PLEASE CALL TOLL FREE 888.878.5536

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KLENSKIN SUNSCREEN FACE AND BODY BROAD SPECTRUM  SPF 30
homosalate, octisalate, zinc gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61369-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9.75 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CUCUMBER SEED OIL (UNII: AKP926H71P)
SHEA BUTTER (UNII: K49155WL9Y)
WATER (UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CASTOR OIL (UNII: D5340Y2I9G)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
CETYL DIMETHICONE 45 (UNII: IK315POC44)
JOJOBA OIL (UNII: 724GKU717M)
RASPBERRY SEED OIL (UNII: 9S8867952A)
GRAPE SEED OIL (UNII: 930MLC8XGG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61369-202-13	88 mL in 1 TUBE; Type 0: Not a Combination Product	11/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/24/2020

Labeler - CoLabs Intl. Corp (829850879)