FDA.reportPublic FDA data

Ulta

Manufacturer
Prime Enterprises, Inc.
Effective date
2021-08-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:30:09

Label at a glance#

ProductUlta SPF 45
Active ingredientZINC OXIDE
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

apply liberally 15 minutes before sun exposure. use a water resistant sunscreen if swimming or sweating. reapply at least every 2 hours. Sunscreen 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, especial...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 25%

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

Do not use on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

apply liberally 15 minutes before sun exposure.

use a water resistant sunscreen if swimming or sweating.

reapply at least every 2 hours.

Sunscreen 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 10am - 2pm.

wear long-sleeve shirts, pants, hats, and sunglasses

children under 6 months: ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Calcium Aluminum Borosilicate, Silica, Nylon-6/12, Triethoxycaprylylsilane, Olive Glycerides, Ascorbyl Palmitate, Iron Oxides, Ceramide NP

Other information

SPL UNCLASSIFIED SECTION

protect this product from excessive heat and direct sun.

may stain some fabrics or surfaces.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-866-983-8582

Ulta Beauty Mineral Hair & Scalp Powder Broad Spectrum SPF 45

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display LabelPrinciple Display Label

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-039358443-0393-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CERAMIDE NP4370DF050BIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
OLIVE OIL6UYK2W1W1EIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CALCIUM ALUMINUM BOROSILICATE3JRB8A35M0IACT
ASCORBYL PALMITATEQN83US2B0NIACT
ZINC OXIDESOI2LOH54ZACTIB
NYLON 612 (MW 14000)E7LN56Z3RXIACT
FERROSOFERRIC OXIDEXM0M87F357IACT

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
ca54fd0f-2e07-1447-e053-2a95a90ae7cebf3bf5b6-f40c-bd6a-e053-2a95a90ab58d2021-08-24WarningsExact identifier
spl id: ca54fd0f-2e07-1447-e053-2a95a90ae7ce
spl set id: bf3bf5b6-f40c-bd6a-e053-2a95a90ab58d

Reported adverse events (FAERS/openFDA)#

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