OTC Medication Information: UNCOMPLIKATED MAKEUP SETTING SPF 50

UNCOMPLIKATED MAKEUP SETTING SPF 50- avobenzone, homosalate, octisalate, octocrylene and oxybenzone aerosol, spray
KATE SOMERVILLE SKINCARE LLC

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.

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 THIS PRODUCT, KEEP OUT OF EYES.

RINSE WITH WARM WATER TO REMOVE.

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

• 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

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 g HOMOSALATE (HOMOSALATE) HOMOSALATE 10 g in 100 g OCTISALATE (OCTISALATE) OCTISALATE 5 g in 100 g OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 10 g in 100 g OXYBENZONE (OXYBENZONE) OXYBENZONE 5 g in 100 g

Inactive Ingredients Ingredient Name Strength ALCOHOL ISOBUTANE PROPANE ISODODECANE ETHYLHEXYL METHOXYCRYLENE POVIDONE, UNSPECIFIED METHYL DIHYDROABIETATE HYALURONIC ACID RHODIOLA ROSEA ROOT WATER LAVENDER OIL SILICA, TRIMETHYLSILYL CAPPED PENTYLENE GLYCOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43479-208-41 96 g in 1 CAN None

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)

Revised: 08/2022 KATE SOMERVILLE SKINCARE LLC