powder

Manufacturer
Oxygen development
Effective date
2023-02-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:50

Label at a glance#

Productpowder
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure12 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 toall 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...

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

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 toall 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 15or 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.

Primary package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-052_AW61354-052_AW61354-052_AW61354-052_AW61354-052_AW61354-052_AW

Secondary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-052-01_AW61354-052-01_AW

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-052-01powder1 in 1 CARTONPOWDER12
61354-052-01powder8 mg in 1 BOTTLE, PLASTICPOWDER82

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-052POWDER (ZINC OXIDE, TITANIUM DIOXIDE) POWDER [OXYGEN DEVELOPMENT]2Legacy NDC, 2 package rows20230211_bbf3e14d-84f3-fe4b-e053-2a95a90a1acc.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
61354-05261354-052-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
f45d2f79-ec62-9e7f-e053-2995a90a48fabbf3e14d-84f3-fe4b-e053-2a95a90a1acc2023-02-10WarningsExact identifier
spl id: f45d2f79-ec62-9e7f-e053-2995a90a48fa
spl set id: bbf3e14d-84f3-fe4b-e053-2a95a90a1acc

Reported adverse events (FAERS/openFDA)#

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