FDA.reportPublic FDA data

Ulta Beauty

Manufacturer
Prime Packaging, Inc. | Prime Enterprises, Inc.
Effective date
2022-03-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:48:35

Label at a glance#

ProductUlta Beauty Broad Spectrum SPF 30
Active ingredientAVOBENZONE, 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 before use spray liberally and spread evenly by hand 15 minutes before sun exposure hold container 4 to 6 inches from the skin to apply do not spray directly into face. Spray on hands then apply to face. 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 t...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocrylene 5%

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 Poision Control Center right away.

Flammable:

OTHER SAFETY INFORMATION

Do not use near heat, flame or while smoking.

Contents under pressure - do not puncture or incinerate.

Do not store at temperatures above 120°F

Directions

DOSAGE & ADMINISTRATION SECTION

shake well before use

spray liberally and spread evenly by hand 15 minutes before sun exposure

hold container 4 to 6 inches from the skin to apply

do not spray directly into face. Spray on hands then apply to face.

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

Fragrance, SD Alcohol 40-B, Tocopheryl Acetate, VA/Butyl Maleate/Isobromyl Acrylate Copolymer

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 Sunscreen Continuous Mist Broad Spectrum SPF 30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display LabelPrinciple Display Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13630-0176-42024-01-30C16284748780-11030e365-1e5c-111a-e063-dadaa90a10e2Ulta Beauty Sunscreen Continuous Mist Broad Spectrum SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13630-0176-4Ulta BeautyBroad Spectrum SPF 30156 g in 1 CANSPRAY1561

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13630-0176ULTA BEAUTY BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]1Legacy NDC, 1 package rows20220303_c5619c39-8b1b-108e-e053-2995a90a2682.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13630-017613630-0176-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
OCTOCRYLENE5A68WGF6WMACTIB
COCONUT OILQ9L0O73W7LIACT

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
c5619c57-139d-d14d-e053-2a95a90ae07dc5619c39-8b1b-108e-e053-2995a90a26822022-03-02WarningsExact identifier
spl id: c5619c57-139d-d14d-e053-2a95a90ae07d
spl set id: c5619c39-8b1b-108e-e053-2995a90a2682

Reported adverse events (FAERS/openFDA)#

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