Uncomplikated Makeup Setting Aerosol, Spray
FDA Label NDC 43479-208

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kate Somerville Skincare Llc for the product Uncomplikated Makeup Setting (NDC 43479-208). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Uncomplikated_label_021417_v3ol (Uncomplikated Label 021417 V3ol)

Uncomplikated_label_021417_v3ol (Uncomplikated Label 021417 V3ol)

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