FDA.reportPublic FDA data

ULTA TANNING SPF 4

Manufacturer
Ulta
Effective date
2015-08-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:34

Label at a glance#

ProductULTA TANNING SPF 4
Active ingredientOCTINOXATE, PADIMATE O
Label structure8 sections

Indications and uses

helps prevent sunburn

Dosage and administration

apply liberally 15 minutes before sun exposure reapply after 80 minutes of swimming or sweating immediately after towel drying at least every2 hours children under 6 months of age: Ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 2.0%, Padimate O 1.4%


Purpose

OTC - PURPOSE SECTION

Sunscreen


Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.


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

Stop use and ask a doctor

OTC - ASK DOCTOR SECTION

if rash occurs

Keep out of reach of childrem

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 every2 hours
  • children under 6 months of age: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Mineral Oil, Cocos Nucifera (Coconut) Oil, Theobroma Cacao (Cocoa) Seed Butter, Aloe Barbadensis Leaf Extract, Musa Sapientum (Banana) Fruit Extract, Retinyl Palmitate (and) Zea Mays (Corn) Oil (and) BHA (and) BHT, Tocopheryl Acetate, Daucus Carota Sativa (Carrot) Root Extract, Fragrance: Alpine Aromatics Coco Rum Banana #122-778, Phenoxyethanol (and) Methylparaben (and) Isopropylparaben (and) Isobutylparaben (and) Butylparaben.

Other information

SPL UNCLASSIFIED SECTION


  • protect this product from excessive heat and direct sun

Principal Display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL



62296-7031-6

DEEP TANNING

DARK TANNING

SPF 4

ALOE VERA

EXOTIC MOISTURIZERS

TROPICAL OIL

ULTA

8 fl oz/ 236 ml

Label
Label






FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62296-7031-62020-01-31C16284748780-19d75b9cf-f2fc-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62296-7031-6ULTA TANNING SPF 4236 g in 1 BOTTLELOTION2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62296-7031ULTA TANNING SPF 4 (OCTINOXATE, PADIMATE O) LOTION [ULTA]1Legacy NDC, 1 package rows20160329_4e600038-f9f0-49df-8f74-ca8a3e3d7d7e.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62296-703162296-7031-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
MINERAL OILT5L8T28FGPIACT
COCONUT OILQ9L0O73W7LIACT
COCOA BUTTER512OYT1CRRIACT
ALOE VERA LEAFZY81Z83H0XIACT
BANANA4AJZ4765R9IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CARROTL56Z1JK48BIACT
PHENOXYETHANOLHIE492ZZ3TIACT
METHYLPARABENA2I8C7HI9TIACT
ISOPROPYLPARABENA6EOX47QK0IACT
ISOBUTYLPARABEN0QQJ25X58GIACT
BUTYLPARABEN3QPI1U3FV8IACT
PADIMATE OZ11006CMUZACTIB

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
b909a65b-a935-4cbe-9e06-e0c2882ed0204e600038-f9f0-49df-8f74-ca8a3e3d7d7e2015-08-03WarningsExact identifier
spl id: b909a65b-a935-4cbe-9e06-e0c2882ed020
spl set id: 4e600038-f9f0-49df-8f74-ca8a3e3d7d7e

Reported adverse events (FAERS/openFDA)#

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