FDA.reportPublic FDA data

powder

Manufacturer
Oxygen development
Effective date
2023-02-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:53:54

Label at a glance#

Productpowder
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure13 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 again caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at lease every 2 hours. Children under 6 months: ask a doctor. Optional: apply to all skin exposed to the sun. Sun Protection measures. Spending time in the sin increases your risk ofg skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 1...

Storage and handling

Protect the product in this container from excessive heat and direct sunlight. You may report a serious adverse reaction to: tarte c/o report Reaction, LLC,P.O.Box 22, Plainsboro, New Jersey 08536-0222.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 8.6%

Zinc Oxide 10.0%

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 again caused by the sun.

Warnings

WARNINGS SECTION

For external use only

Stop Use

OTC - STOP USE SECTION

Stop use and ask doctor if rash occurs

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 the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control center rigth away

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at lease every 2 hours.
  • Children under 6 months: ask a doctor.
  • Optional: apply to all skin exposed to the sun.
  • Sun Protection measures. Spending time in the sin increases your risk ofg skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: - limit time in the sun, especially from 10 a.m-2p.m. - Wear long-sleeved shirts, pants, hats and sunglasses.

Other information

STORAGE AND HANDLING SECTION

  • Protect the product in this container from excessive heat and direct sunlight.
  • You may report a serious adverse reaction to: tarte c/o report Reaction, LLC,P.O.Box 22, Plainsboro, New Jersey 08536-0222.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Polymethylsilsesquioxane, silica, jojoba esters, caprylyl glycol, alumina, sodium dehydroacetate, phenoxyethanol, vanillin, caprylic/capric triglyceride, hexylene glycol, vanilla planifolia fruit extract, aluminum dimyristate, triethoxycaprylylsilane, disodium stearoyl glutamate, mica, iron oxides. OX100FW000041.

Primary package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-052-02_AW61354-052-02_AW8g 61354-052-02

Secondary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-052-02_AW61354-052-02_AW8g 61354-052-02

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61354-052-022025-01-30C16284748780-1f386c649-fa73-0266-e053-dadaa90a7c1aSEA SET & PROTECT MINERAL POWDER SUNSCREEN BROAD SPECTRUM SPF 30 TRANSLUCENT
61354-052-022023-02-10C16284748780-1f386c649-fa73-0266-e053-dadaa90a7c1aSEA SET & PROTECT MINERAL POWDER SUNSCREEN BROAD SPECTRUM SPF 30 TRANSLUCENT
61354-052-022023-01-30C16284748780-1f386c649-fa73-0266-e053-dadaa90a7c1aSEA SET & PROTECT MINERAL POWDER SUNSCREEN BROAD SPECTRUM SPF 30 TRANSLUCENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-052-02powder1 in 1 CARTONPOWDER13
61354-052-02powder8 mg in 1 BOTTLE, PLASTICPOWDER83

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-052POWDER (ZINC OXIDE, TITANIUM DIOXIDE) POWDER [OXYGEN DEVELOPMENT]3Legacy NDC, 2 package rows20230211_bc2bd616-272c-94d0-e053-2a95a90a598e.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61354-05261354-052-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
JOJOBA OIL724GKU717MIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB

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
f45d0980-06f3-49b4-e053-2a95a90a8ff1bc2bd616-272c-94d0-e053-2a95a90a598e2023-02-10WarningsExact identifier
spl id: f45d0980-06f3-49b4-e053-2a95a90a8ff1
spl set id: bc2bd616-272c-94d0-e053-2a95a90a598e

Reported adverse events (FAERS/openFDA)#

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