Cream

Manufacturer
Oxygen Development LLC
Effective date
2023-02-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:49

Label at a glance#

ProductCream
Active ingredientTITANIUM DIOXIDE
Label structure13 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures. Decreased the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

for sunscreen use: apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months ask a doctor

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 17%. Purpose: Sunscreen

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

helps prevent sunburn if used as directed with other sun protection measures. Decreased 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

OTC - WHEN USING SECTION

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

Stop use

OTC - STOP USE SECTION

and ask a doctor 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

Directions

DOSAGE & ADMINISTRATION SECTION

for sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months ask a doctor

Sun protection measures

OTHER SAFETY INFORMATION

spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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-slevve shirts, pants, hats, and sunglasses

Inactive ingredients

INACTIVE INGREDIENT SECTION

isododecane, disteardimonium hectorite, Polymethylsilsesquioxane, Caprylic/Capric Triglyceride, propylene carbonate, silica, Trimethylsiloxysilicate, Dipalmitoyl Hydroxyproline, Mangifera Indica (Mango) Seed Butter, Carthamus Tinctorius (Safflower) Seed Oil, Camellia Oleifera Leaf Extract, Acrylates Copolymer, Diacetyl Boldine, Calcium Sodium Borosilicate, Calcium Aluminum Borosilicate, tin oxide, phenoxyethanol, may contain: mica, carmine, titanium dioxide, iron oxides, Bismuth Oxychloride,chromium hydroxide green, chromium oxide greens, ferric fenocyanide, manganese violet, ultramarines

other information

STORAGE AND HANDLING SECTION

protect this product from excessive heat and direct sun

package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-080-07_AW61354-080-07_AW

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-080-01Cream3 mg in 1 BOTTLECREAM32
61354-080-07Cream1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-080CREAM (TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC]2Legacy NDC, 2 package rows20230211_bbeffa0a-2bc6-fea4-e053-2a95a90ac511.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61354-08061354-080-01, 61354-080-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
f45d319f-0fa2-c392-e053-2995a90a26dabbeffa0a-2bc6-fea4-e053-2a95a90ac5112023-02-10WarningsExact identifier
spl id: f45d319f-0fa2-c392-e053-2995a90a26da
spl set id: bbeffa0a-2bc6-fea4-e053-2a95a90ac511

Reported adverse events (FAERS/openFDA)#

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