Kate Somerville (as Pld) - Uncomplikated Makeup Setting Spray Spf 50 (43479-208)

Kate Somerville (as Pld) - Uncomplikated Makeup Setting Spray Spf 50 (43479-208)
SPL v11
SPL
SPL Set ID 44ec0db5-4437-e4a3-e063-6294a90a9a00
Route
TOPICAL
Published
Effective Date 2020-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (10 g) Octisalate (5 g) Octocrylene Oxybenzone
Inactive Ingredients
Isobutane Propane Isododecane Ethylhexyl Methoxycrylene Povidone, Unspecified Methyl Dihydroabietate Hyaluronic Acid Rhodiola Rosea Root Water Lavender Oil Silica, Trimethylsilyl Capped Pentylene Glycol Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-11-18
Description

AVOBENZONE      3.00% HOMOSALATE      10.00% OCTISALATE      5.00% OCTOCRYLENE   10.00% OXYBENZONE      5.00%

Purpose

SUNSCREEN

Medication Information

Purpose

SUNSCREEN

Dosage and 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.
Description

AVOBENZONE      3.00% HOMOSALATE      10.00% OCTISALATE      5.00% OCTOCRYLENE   10.00% OXYBENZONE      5.00%

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.
Section 50565-1

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

Section 50566-9

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

Section 50567-7

WHEN USING THIS PRODUCT, KEEP OUT OF EYES.

RINSE WITH WARM WATER TO REMOVE.

Section 51945-4

Warnings

FOR EXTERNAL USE ONLY

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.
Active Ingredients

AVOBENZONE      3.00%

HOMOSALATE      10.00%

OCTISALATE      5.00%

OCTOCRYLENE   10.00%

OXYBENZONE      5.00%

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

Structured Label Content

Uses (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.
Dosage and Administration (34068-7)
  • 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.
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

Section 50567-7 (50567-7)

WHEN USING THIS PRODUCT, KEEP OUT OF EYES.

RINSE WITH WARM WATER TO REMOVE.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

SUNSCREEN

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

Other Information (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.
Active Ingredients (ACTIVE INGREDIENTS)

AVOBENZONE      3.00%

HOMOSALATE      10.00%

OCTISALATE      5.00%

OCTOCRYLENE   10.00%

OXYBENZONE      5.00%

Inactive Ingredients (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:24.204824 · Updated: 2026-03-14T23:10:48.259693