FDA.reportPublic FDA data

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 23:53:52

Label at a glance#

Productpowder
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure14 sections

Indications and uses

Help precent 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 generously 15 minutes before sun exposure. Children under 6 months of age: ask a doctor. Reapply: immediately after towel drying. At least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Sun protections measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad Spectrum SPF value of 15 or hi...

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 15%

Zinc oxide 17%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Help precent 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

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.

Stop use

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a poison controler center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Apply generously 15 minutes before sun exposure. Children under 6 months of age: ask a doctor.

Reapply: immediately after towel drying. At least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Sun protections measures. Spending time in the sun increases your risk of 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: lomit 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 sun

Iniactive ingredient

INACTIVE INGREDIENT SECTION

pollymethylsilsesquoxane, silica, jojoba esters, alumina, oryza sativa (rice)extract, caprylyl glycol, phenoxyethanol, hexylene glycol, aluminum dimyristate, triethoxycaprylylsilane, disodium stearoyl glutamate, iron oxides, mica.

Questions or Comments

OTHER SAFETY INFORMATION

(844) 821 8151

Pimary package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-061-01_AW61354-061-01_AW

Secondary package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-061-01_AW61354-061-01_AW

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61354-061-012025-01-30C16284748780-1f386c64a-1cce-0266-e053-dadaa90a7c1aTouch Behold SPF FINISHING POWDER BROAD SPECTRUM SPF 25
61354-061-012023-02-10C16284748780-1f386c64a-1cce-0266-e053-dadaa90a7c1aTouch Behold SPF FINISHING POWDER BROAD SPECTRUM SPF 25
61354-061-012023-01-30C16284748780-1f386c64a-1cce-0266-e053-dadaa90a7c1aTouch Behold SPF FINISHING POWDER BROAD SPECTRUM SPF 25

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-061-01powder4 g in 1 BOTTLE, PLASTICPOWDER42
61354-061-01powder1 in 1 CARTONPOWDER12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-061POWDER (ZINC OXIDE, TITANIUM DIOXIDE) POWDER [OXYGEN DEVELOPMENT]2Legacy NDC, 2 package rows20230211_bc032168-a5e8-0868-e053-2a95a90abc61.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61354-06161354-061-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
JOJOBA OIL724GKU717MIACT
ZINC OXIDESOI2LOH54ZACTIB
MICAV8A1AW0880IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT

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
f45d48dd-ede6-06b9-e053-2995a90a1607bc032168-a5e8-0868-e053-2a95a90abc612023-02-10WarningsExact identifier
spl id: f45d48dd-ede6-06b9-e053-2995a90a1607
spl set id: bc032168-a5e8-0868-e053-2a95a90abc61

Reported adverse events (FAERS/openFDA)#

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