FDA.reportPublic FDA data

Powder

Manufacturer
Oxygen Development LLC
Effective date
2022-01-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:46:35

Label at a glance#

ProductPowder
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure11 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. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children unther 6 months: Ask a doctor. Optional: apply to all skin exposed to the sun. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or...

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 aging 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

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 the 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 unther 6 months: Ask a doctor.

Optional: apply to all skin exposed to the sun.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer 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

OTHER SAFETY INFORMATION

Protect the prodcut in this container from excessive heat and direct sunlight.

You may report a serious adverse reaction to: tarte c/o Report Reaction, LLC, PO. Box 22, Plainsboro, New Jersey 08536-0222

Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-043-01_AW61354-043-01_AW

Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-043-02_AW61354-043-02_AW

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61354-043-022025-01-30C16284748780-12cef2736-858a-d83d-e063-dadaa90ab31fd550fbe8-cb48-1037-e053-2995a90a0cac

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-043-01Powder8 g in 1 BOTTLEPOWDER81
61354-043-02Powder1 in 1 CARTONPOWDER11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-043POWDER (ZINC OXIDE) POWDER [OXYGEN DEVELOPMENT LLC]1Legacy NDC, 2 package rows20220112_d550fbe8-cb48-1037-e053-2995a90a0cac.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61354-04361354-043-01, 61354-043-02

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
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
POTASSIUM HYDROLYZED JOJOBA ESTERSCH428W5O62IACT

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
d550fbe8-cb49-1037-e053-2995a90a0cacd550fbe8-cb48-1037-e053-2995a90a0cac2022-01-11WarningsExact identifier
spl id: d550fbe8-cb49-1037-e053-2995a90a0cac
spl set id: d550fbe8-cb48-1037-e053-2995a90a0cac

Reported adverse events (FAERS/openFDA)#

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