Powder

Manufacturer
Oxygen Development LLC
Effective date
2023-06-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:29:51

Label at a glance#

ProductPowder
Active ingredientZINC OXIDE
Label structure11 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 doctor • Sun Protection 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 meas...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 24.5%

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 damaged or broken skin.

When using

OTC - WHEN USING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is
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 under 6 months: Ask a doctor •
Sun Protection 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:
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 Aluminum 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
Extract, Psidium Guajava Fruit Extract, Iron
Oxides.

Other Information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat
and direct sun.

Purpose

OTC - PURPOSE SECTION

Sunscreen Agent

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-093_aw61354-093_aw

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-093-01_aw61354-093-01_aw

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61354-093-012025-01-30C16284748780-12cef2736-abc3-d83d-e063-dadaa90ab31fHawaiian Tropic Mineral Translucent Sunscreen Powder SPF 30

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
61354-09361354-093-01

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
fe4526cd-cb7a-6504-e053-6394a90a37e6fe4526cd-cb79-6504-e053-6394a90a37e62023-06-16WarningsExact identifier
spl id: fe4526cd-cb7a-6504-e053-6394a90a37e6
spl set id: fe4526cd-cb79-6504-e053-6394a90a37e6

Reported adverse events (FAERS/openFDA)#

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