UNCOMPLIKATED MAKEUP SETTING SPF 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, spray

UNCOMPLIKATED MAKEUP SETTING by

Drug Labeling and Warnings

UNCOMPLIKATED MAKEUP SETTING by is a Otc medication manufactured, distributed, or labeled by KATE SOMERVILLE SKINCARE LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

AVOBENZONE      3.00%

HOMOSALATE      10.00%

OCTISALATE      5.00%

OCTOCRYLENE   10.00%

OXYBENZONE      5.00%

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

WHEN USING

WHEN USING THIS PRODUCT, KEEP OUT OF EYES.

RINSE WITH WARM WATER TO REMOVE.

STOP USE

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

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.

DOSAGE & ADMINISTRATION

• SHAKE WELL PRIOR TO USE.
• AVOID SPRAYING ON OR AROUND EYE AREA. CLOSE MOUTH.
• HOLD CAN 8-10" FROM FACE AND SPRAY IN A CLOCKWISE DIRECTION.
• DO NOT APPLY IN WINDY CONDITIONS.
• USE IN A WELL-VENTILATED AREA.
• APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
• USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
• REAPPLY AT LEAST EVERY 2 HOURS.

• 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 VALUE 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 THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.
• YOU MAY REPORT A SERIOUS ADVERSE REACTION FROM USING THIS PRODUCT TO 1-800-984-KATE ON WEEKDAYS 9 A.M.-5 P.M. PST.

INACTIVE INGREDIENTS

ALCOHOL DENAT., ISOBUTANE, PROPANE, ISODODECANE, ETHYLHEXYL METHOXYCRYLENE, PVP, METHYL DIHYDROABIETATE, HYDROLYZED HYALURONIC ACID, RHODIOLA ROSEA ROOT EXTRACT, KATER/AQUA/EAU, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, SILICA SILYLATE, PENTYLENE GLYCOL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UNCOMPLIKATED MAKEUP SETTING  SPF 50
avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43479-208
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ISOBUTANE (UNII: BXR49TP611)
PROPANE (UNII: T75W9911L6)
ISODODECANE (UNII: A8289P68Y2)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
HYALURONIC ACID (UNII: S270N0TRQY)
RHODIOLA ROSEA ROOT (UNII: 3S5ITS5ULN)
WATER (UNII: 059QF0KO0R)
LAVENDER OIL (UNII: ZBP1YXW0H8)
SILICA, TRIMETHYLSILYL CAPPED (UNII: VU10KU4B9S)
PENTYLENE GLYCOL (UNII: 50C1307PZG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43479-208-41	96 g in 1 CAN; Type 0: Not a Combination Product	11/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/18/2018

Labeler - KATE SOMERVILLE SKINCARE LLC (615155533)

Establishment
Name	Address	ID/FEI	Business Operations
KIK Piedmont LLC		884802658	manufacture(43479-208)