HAWAIIAN TROPIC MINERAL TRANSLUCENT SUNSCREEN POWDER SPF 30- zinc oxide powder

Hawaiian Tropic Mineral Translucent Sunscreen Powder SPF 30 by

Drug Labeling and Warnings

Hawaiian Tropic Mineral Translucent Sunscreen Powder SPF 30 by is a Otc medication manufactured, distributed, or labeled by Edgewell Personal Care Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Zinc Oxide 24.5%

Purpose

Sunscreen Agent

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

Warnings:

For external use only.

Do not use

on damaged 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:

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:

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

Protect this product from excessive heat and direct sun.

Questions or Comments?

1- 800- NO UV RAY, Mon-Fri

Principal Display Panel

HAWAIIAN

Tropic (R)

MINERAL

TRANSLUCENT

SUNSCREEN POWDER

30

SUNSCREEN BROAD SPECTRUM SPF 30

UVA/UVB

.15 OZ. (4.25 g)

HAWAIIAN

Tropic (R)

MINERAL

TRANSLUCENT

SUNSCREEN POWDER

30

SUNSCREEN BROAD SPECTRUM SPF 30

.15 OZ. (4.25 g)

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC MINERAL TRANSLUCENT SUNSCREEN POWDER SPF 30 
zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-820
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CERAMIDE NP (UNII: 4370DF050B)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MANGO (UNII: I629I3NR86)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
GUAVA (UNII: 74O70D6VG0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SEA SALT (UNII: 87GE52P74G)
PAPAYA (UNII: KU94FIY6JB)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-820-21	4.25 g in 1 TUBE; Type 0: Not a Combination Product	11/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/15/2021

Labeler - Edgewell Personal Care Brands LLC (151179769)