Powder

Manufacturer
Oxygen Development LLC
Effective date
2023-02-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:53:57

Label at a glance#

ProductPowder
Active ingredientZINC OXIDE
Label structure7 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the risk of 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 under 6 months: Ask a docstor Sun Protection Measures. Spendign time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regulary use a sunscreen with a Board Spectrum SPF value of 15 or higher and other sun protection measures inclu...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 24.5%

Sunscreen Agent

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only.

Do not use on damage or broken skin.

When using this product: Avoid inhalation.

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

if product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

INSTRUCTIONS FOR USE 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 docstor

Sun Protection Measures. Spendign time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regulary use a sunscreen with a Board Spectrum SPF value of 15 or higher and other sun protection measures including limit time in the sun, especially from 10 a.m - 2 p.m, wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Calcium Aluminunm Borosilicate, Silica, Ethylhexylglycerin, Sodium Dehydroacetate, Fragrance, Sea Salt, Ceramide NP, Ascorbyl Palmitate, Caprylic/Capric Triglyceride, Triethoxycaprylylsilane, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extrat, Psidium Guajava Fruit Extract, Iron Oxides

Other information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-017-01_uc61354-017-01_uc61354-017-01_AW61354-017-01_AW

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61354-017-012025-01-30C16284748780-12cef2736-825a-d83d-e063-dadaa90ab31fHawaiian Tropic mineral translucent powder sunscreen broad spectrum SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-017-01Powder1 in 1 CARTONPOWDER13
61354-017-01Powder100 g in 1 BOTTLEPOWDER1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-017POWDER (ZINC OXIDE) POWDER [OXYGEN DEVELOPMENT LLC]3Legacy NDC, 2 package rows20230211_cf6c7623-21b7-17f1-e053-2a95a90a7054.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
61354-01761354-017-01

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
f45cbf13-de13-51eb-e053-2995a90a7a55cf6c7623-21b7-17f1-e053-2a95a90a70542023-02-10WarningsExact identifier
spl id: f45cbf13-de13-51eb-e053-2995a90a7a55
spl set id: cf6c7623-21b7-17f1-e053-2a95a90a7054

Reported adverse events (FAERS/openFDA)#

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