FDA.reportPublic FDA data

KATE SOMERVILLE (as PLD) - UNCOMPLIKATED MAKEUP SETTING SPRAY SPF 50 (43479-208)

Manufacturer
KATE SOMERVILLE SKINCARE LLC
Effective date
2025-01-12
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:52:26

Label at a glance#

ProductUNCOMPLIKATED MAKEUP SETTING SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure11 sections

Indications and 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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

AVOBENZONE      3.00%

HOMOSALATE      10.00%

OCTISALATE      5.00%

OCTOCRYLENE   10.00%

OXYBENZONE      5.00%

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USES

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

FOR EXTERNAL USE ONLY

OTC - WHEN USING SECTION

WHEN USING THIS PRODUCT, KEEP OUT OF EYES.

RINSE WITH WARM WATER TO REMOVE.

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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_v3OLUncompliKated_label_021417_v3OL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43479-208-41UNCOMPLIKATED MAKEUP SETTINGSPF 5096 g in 1 CANAEROSOL, SPRAY9610

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43479-208UNCOMPLIKATED MAKEUP SETTING SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, SPRAY [KATE SOMERVILLE SKINCARE LLC]10Current NDC, Legacy NDC, 1 package rows20250113_1a33cb41-440a-41cb-9832-24255bfa2b7c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43479-20843479-208-41

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOBUTANEBXR49TP611IACT
PROPANET75W9911L6IACT
ISODODECANEA8289P68Y2IACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
HYALURONIC ACIDS270N0TRQYIACT
RHODIOLA ROSEA ROOT3S5ITS5ULNIACT
WATER059QF0KO0RIACT
LAVENDER OILZBP1YXW0H8IACT
SILICA, TRIMETHYLSILYL CAPPEDVU10KU4B9SIACT
PENTYLENE GLYCOL50C1307PZGIACT
ALCOHOL3K9958V90MIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UNCOMPLIKATED MAKEUP SETTING SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEKATE SOMERVILLE SKINCARE LLC1a33cb41-440a-41cb-9832-24255bfa2b7c2025-01-12WarningsExact identifier
ndc (package): 43479-208-41
ndc (product): 43479-208
ndc11 (package): 43479020841
spl id: 2b826d62-b441-974d-e063-6394a90a109d
spl set id: 1a33cb41-440a-41cb-9832-24255bfa2b7c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.