FDA.reportPublic FDA data

ULTA Beauty 50 Sun Protection Broad Spectrum SPF 50 Sunscreen Mineral Lotion

Manufacturer
Prime Enterprises Inc.
Effective date
2021-01-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:56:55

Label at a glance#

ProductULTA beauty Broad Spectrum SPF 50 Mineral
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
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 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 broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, es...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 4 %

Zinc Oxide 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.

OTC - ASK DOCTOR 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • 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 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

Alumina, Butyrospermum Parkii (Shea) Butter, C13-15 Alkane, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Allantoin, Alumina, Butyrospermum Parkii (Shea) Butter, Camellia Oleifera (Green Tea) Leaf Extract, Cetyl PEG/PPG-10/1 Dimethicone, Cucumis Sativus (Cucumber) Extract, Cyclopentasiloxane, Dimethicone Crosspolymer, Disodium EDTA, Disteardimonium Hectorite, Ethylhexylglycerin, Fragrance, Glycerin, Hexyl Laurate, Linum Usitatissimum (Linseed) Seed Oil, Oenothera Biennis (Evening Primrose) Oil, PEG-10 Dimethicone, Phenoxyethanol, Plankton Extract, Polyglyceryl-4 Isostearate, Polymethylsilsesquioxane, Rosa Canina Seed Oil, Silica, Stearic Acid, Tocopheryl Acetate, Water

Other information

SPL UNCLASSIFIED SECTION

  • protect this product from excessive heat and direct sun
  • avoid contact with fabrics - could cause discoloration

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-866-983-8582

ULTA beauty 50 Suns Protection BROAD SPECTRUM SPF 50 SUNSCREEN Mineral Lotion

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pricipal Display LabelPricipal Display Label

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-026958443-0269-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
LINSEED OIL84XB4DV00WIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
EVENING PRIMROSE OIL3Q9L08K71NIACT
EDETATE DISODIUM7FLD91C86KIACT
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
CUCUMBERYY7C30VXJTIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
ROSA CANINA SEED4503R1M9UTIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ZINC OXIDESOI2LOH54ZACTIB
ALUMINUM OXIDELMI26O6933IACT
ALLANTOIN344S277G0ZIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
SHEA BUTTERK49155WL9YIACT
WATER059QF0KO0RIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
GLYCERINPDC6A3C0OXIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
CYCLOMETHICONE 50THT5PCI0RIACT
HEXYL LAURATE4CG9F9W01QIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
STEARIC ACID4ELV7Z65APIACT

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
e77aebf1-31fc-a318-e053-2a95a90ae1488cc796a7-1d79-d4a7-e053-2995a90a07de2022-08-30WarningsExact identifier
spl set id: 8cc796a7-1d79-d4a7-e053-2995a90a07de

Reported adverse events (FAERS/openFDA)#

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