Hawaiian Tropic Mineral Face Skin Nourishing Tinted Milk Coconut Oil Spf30 Oil
FDA Label NDC 63354-643

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Edgewell Personal Care Brands Llc for the product Hawaiian Tropic Mineral Face Skin Nourishing Tinted Milk Coconut Oil Spf30 (NDC 63354-643). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor

→ Keep Out Of Reach Of Children.

→ Directions

→ Inactive Ingredients

→ Other Information

→ Questions Or Comments?

→ Principal Display Panel

Active Ingredients

Titanium Dioxide 4.3%, Zinc Oxide 6.0% .

Purpose

Sunscreen

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

Warnings

For external use only.

May stain some fabrics and surfaces.

Do Not Use

on damaged or broken skin.

When Using This Product

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

• 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

Water, Caprylic/Capric Triglyceride, C12‐15 Alkyl Benzoate, Glycerin, Dimethicone, Cetyl PEG/PPG‐10/1 Dimethicone, Lauryl PEG‐8 Dimethicone, VP/Eicosene Copolymer, Sodium Chloride, Cocos Nucifera (Coconut) Oil, Glyceryl Stearate, Polyhydroxystearic Acid, Alcohol Denat., Phenoxyethanol, Stearalkonium Bentonite, Caprylyl Glycol, Fragrance, Alumina, Mica, Propylene Carbonate, Aleurites Moluccanus Seed Oil, Ethylhexylglycerin, Triethoxycaprylylsilane, Titanium Dioxide, Magnesium Stearate, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Bismuth Oxychloride, Iron Oxides.