Hawaiian Tropic Mineral Skin Nourishing Milk Sunscreen Broad Spectrum SPF 30

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2024-11-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:33:29

Label at a glance#

ProductHawaiian Tropic Mineral Skin Nourishing Milk Sunscreen Broad Spectrum SPF 30
Active ingredientZINC OXIDE
Label structure9 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

• shake well • apply liberally 15 minutes before sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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 in...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 15.0%

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.

Flammable: Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking.

May stain some fabrics.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

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

• shake well • apply liberally 15 minutes before sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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 longsleeved shirts, pants, hats, and sunglasses • children under 6 months: Ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Isododecane, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Stearyl/Octyldodecyl Citrate Crosspolymer, Cocos Nucifera (Coconut) Oil, Phenoxyethanol, Polyhydroxystearic Acid, Fragrance, Triethoxycaprylylsilane, Aleurites Moluccanus Seed Oil, Tocopheryl Acetate, Sodium Citrate, Aloe Barbadensis Leaf Juice, Glycerin, Mica, Titanium Dioxide, 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

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun

Questions or Comments?

OTC - QUESTIONS SECTION

1-800-NO UV RAY, Mon-Fri

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW
HAWAIIAN
TROPIC(R)
MINERAL
SKIN NOURISHING
MILK
30
SUNSCREEN BROAD SPECTRUM SPF30
UVA/UVB
OXYBENZONE & OCTINOXATE FREE
CRUELTY-FREE
SHAKE WELL BEFORE USE
3.4 FL. OZ. (100 mL)

63354-421-12 label63354-421-12 label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-421-12Hawaiian Tropic Mineral Skin Nourishing Milk Sunscreen Broad Spectrum SPF 30100 g in 1 BOTTLE, PUMPLOTION1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-421HAWAIIAN TROPIC MINERAL SKIN NOURISHING MILK SUNSCREEN BROAD SPECTRUM SPF 30 (ZINC OXIDE) LOTION [EDGEWELL PERSONAL CARE BRANDS LLC]4Current NDC, Legacy NDC, 1 package rows20241103_c8d6c731-2dfc-71c0-e053-2a95a90aa5b8.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-42163354-421-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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
Hawaiian Tropic Mineral Skin Nourishing Milk Sunscreen Broad Spectrum SPF 30ZINC OXIDEEdgewell Personal Care Brands LLCc8d6c731-2dfc-71c0-e053-2a95a90aa5b82024-11-01WarningsExact identifier
ndc (package): 63354-421-12
ndc (product): 63354-421
ndc11 (package): 63354042112
spl id: 25dc8df3-8b85-95b0-e063-6394a90ac575
spl set id: c8d6c731-2dfc-71c0-e053-2a95a90aa5b8

Reported adverse events (FAERS/openFDA)#

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