FDA.reportPublic FDA data

Ulta Beauty Facial Setting Spray Broad Spectrum SPF 50

Manufacturer
Prime Enterprises, Inc.
Effective date
2021-04-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:43:30

Label at a glance#

ProductUlta SPF 50
Active ingredientHOMOSALATE, AVOBENZONE, 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...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10%

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.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove. Keep away from face to avoid breathing it.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Flammable:

OTHER SAFETY INFORMATION

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-sleeve shirts, pants, hats, and sunglasses

children under 6 months: Ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol Denat, Cyclopentasiloxane, Aloe Barbadensis Leaf Juice, Water, Va/Butyl Maleate/Isobornyl Acrylate Copolymer, Rosa Damascena Flower Water, Mentha Viridis (Spearmint) Leaf Oil, Bisabolol, Polyester-8, Tocopheryl Acetate, Ascorbyl Palmitate, Glycerin, Camellia Oleifera (Green Tea) Leaf Extract, Benzyl Alcohol, Dehydroacetic Acid, Sodium Hyaluronate

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 Beauty Facial Setting Spray 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 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-039558443-0395-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
BENZYL ALCOHOLLKG8494WBHIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DEHYDROACETIC ACID2KAG279R6RIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HOMOSALATEV06SV4M95SACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
GLYCERINPDC6A3C0OXIACT
SPEARMINT OILC3M81465G5IACT
ALCOHOL3K9958V90MIACT
ROSA DAMASCENA FLOWER OIL18920M3T13IACT
HYALURONATE SODIUMYSE9PPT4THIACT
ASCORBYL PALMITATEQN83US2B0NIACT
LEVOMENOL24WE03BX2TIACT
WATER059QF0KO0RIACT

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
bf3d7e62-90a0-b61e-e053-2a95a90ae846bf3d7e62-909f-b61e-e053-2a95a90ae8462021-04-05WarningsExact identifier
spl id: bf3d7e62-90a0-b61e-e053-2a95a90ae846
spl set id: bf3d7e62-909f-b61e-e053-2a95a90ae846

Reported adverse events (FAERS/openFDA)#

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