FDA.reportPublic FDA data

ULTA Makeup Setting Spray SPF 50

Manufacturer
Prime Packaging, Inc. | Prime Enterprises, Inc.
Effective date
2020-09-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:12:09

Label at a glance#

ProductULTA SPF 50
Active ingredientOXYBENZONE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure9 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

Dosage and administration

shake well close eyes completely Mist over face evenly, holding bottle 10-12 inches away from face Do not breathe mist in. Wait until dry. apply liberally and evenly 15 minutes before sun exposure do not apply in windy conditions use in a well-ventilated area reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures: Spending time in the sun inc...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.75%

Oxybenzone 4%

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 - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product Keep out of eyes. Rinse with water to remove. Do not inhale.

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.

SPL UNCLASSIFIED SECTION

Flammable: Do not use near heat, flame, or while smoking.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well
  • close eyes completely
  • Mist over face evenly, holding bottle 10-12 inches away from face
  • Do not breathe mist in. Wait until dry.
  • apply liberally and evenly 15 minutes before sun exposure
  • do not apply in windy conditions
  • use in a well-ventilated area
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • 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 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol Denat, Aloe Barbadensis Leaf Juice, Ascorbyl Palmitate, Benzimidazole Diamond Amidoethyl Urea Carbamoyl Propyl Polymethylsilsesquioxane, Benzyl Alcohol, Bisabolol, Camellia Oleifera (Green Tea) Leaf Extract, Cyclopentasiloxane, Dehydroacetic Acid, Fragrance, Glycerin, Polyester-8, Rosa Damascena Flower Water, Silica Silylate, Sodium Hyaluronate, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water

Other information

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sun
  • avoid spraying on fabrics - could cause discoloration

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-866-983-8582

Ulta Makeup Setting Broad Spectrum SPF 50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13630-017113630-0171-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
LEVOMENOL24WE03BX2TIACT
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
BENZYL ALCOHOLLKG8494WBHIACT
ASCORBYL PALMITATEQN83US2B0NIACT
OXYBENZONE95OOS7VE0YACTIB
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ISOBORNYL ACRYLATEIX0PRH184PIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
VINYL ACETATEL9MK238N77IACT
DIBUTYL MALEATE4X371TMK9KIACT
KAKADU PLUM0ZQ1D2FDLIIACT
TEA TREE OILVIF565UC2GIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
CYCLOMETHICONE 50THT5PCI0RIACT
DEHYDROACETIC ACID2KAG279R6RIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
ROSA DAMASCENA FLOWER OIL18920M3T13IACT

Source Document#

Source XML

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
e9ba1a80-3513-cf6f-e053-2995a90ac3f1b08beef1-81e3-9584-e053-2995a90ae9042022-09-28WarningsExact identifier
spl set id: b08beef1-81e3-9584-e053-2995a90ae904

Reported adverse events (FAERS/openFDA)#

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