FDA.reportPublic FDA data

Powder

Manufacturer
Oxygen Development LLC | Oxygen Development DR Limited
Effective date
2025-05-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:00:31

Label at a glance#

ProductPowder
Active ingredientFERRIC OXIDE RED, TITANIUM DIOXIDE
Label structure11 sections

Indications and uses

Helps prevent sunburn.

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 • Children under 6 months: ask a doctor

Storage and handling

Protect this product from excessive heat and direct sun • In the unlikely event of an adverse reaction, please contact 1.866.PUR.0022.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

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

OTC - WHEN USING SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Keep out of reach of children. If 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 • Children under 6 months: ask a doctor

Other Information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun • In the unlikely event of an adverse reaction, please contact 1.866.PUR.0022.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Mica, Caprylic/Capric Triglyceride, Boron Nitride, Bismuth Oxychloride, Zinc Stearate, Magnesium Silicate, Sodium Starch Octenylsuccinate, Mannitol, Sodium Gluconate, Citric Acid, Sodium Citrate, Waltheria Indica Leaf Extract, Dextrin, Ferulic Acid, Lactic Acid (L), Butyrospermum Parkii (Shea) Butter, Retinol, Ceramide AP, Silica, Tocopheryl Acetate, Aqua, Glucosamine HCI, Pisum Sativum (Pea) Extract, Bambusa Vulgaris Leaf/Stem Extract, Magnesium Carbonate, Iron Oxides (CI 77491, CI 77492, CI 77499), May Contain: Titanium Dioxide (CI 77891), Ultramarines (CI 77007).

Package label - Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-118-02_aw61354-118-02_aw61354-118-02-aw61354-118-02-aw61354-118-02 aw-61354-118-02 aw-

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-118-01Powder100 mg in 1 CUPPOWDER1002
61354-118-02Powder1 in 1 CARTONPOWDER12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-118POWDER (TITANIUM DIOXIDE) POWDER [OXYGEN DEVELOPMENT LLC]2Current NDC, 2 package rows20250508_08b7eeeb-09ae-ffe6-e063-6294a90aba90.zip

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
61354-11861354-118-01, 61354-118-02

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
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
MAGNESIUM SILICATE9B9691B2N9IACT
MANNITOL3OWL53L36AIACT
BORON NITRIDE2U4T60A6YDIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
MICAV8A1AW0880IACT
BISMUTH OXYCHLORIDE4ZR792I587IACT
ZINC STEARATEH92E6QA4FVIACT
FERRIC OXIDE RED1K09F3G675ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
PowderTITANIUM DIOXIDEOxygen Development LLC08b7eeeb-09ae-ffe6-e063-6294a90aba902025-05-07WarningsExact identifier
ndc (package): 61354-118-02
ndc (package): 61354-118-01
ndc (product): 61354-118
ndc11 (package): 61354011802
ndc11 (package): 61354011801
spl id: 348c5e36-13f6-cc86-e063-6394a90a8de8
spl set id: 08b7eeeb-09ae-ffe6-e063-6294a90aba90

Reported adverse events (FAERS/openFDA)#

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