FDA Label for Uncomplikated Makeup Setting Spf 50

View Indications, Usage & Precautions

Uncomplikated Makeup Setting Spf 50 Product Label

The following document was submitted to the FDA by the labeler of this product Kate Somerville Skincare Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


Otc - When Using



WHEN USING THIS PRODUCT, KEEP OUT OF EYES.

RINSE WITH WARM WATER TO REMOVE.


Otc - Stop Use



STOP USE AND ASK A DOCTOR IF RASH OCCURS.


Otc - 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


Package Label.Principal Display Panel




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