HAWAIIAN TROPIC MATTE EFFECT MINERAL ENRICHED SUNSCREEN SPF 50- homosalate,octisalate,octocrylene,zinc oxide lotion

Hawaiian Tropic Matte Effect Mineral Enriched Sunscreen SPF 50 by

Drug Labeling and Warnings

Hawaiian Tropic Matte Effect Mineral Enriched Sunscreen SPF 50 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

Homosalate 8.0%, Octisalate 4.5%, Octocrylene 5.7%, Zinc Oxide 7.3%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decrease the risk of skin 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

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.

May stain

some fabrics.

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 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 children under 6 months: Ask a doctor.

Inactive ingredients

Water, Isohexadecane, Cetyl Alcohol, Glycerin, VP/Eicosene Copolymer, PEG-100 Stearate, Glyceryl Stearate, Alcohol Denat., Silica, Phenoxyethanol, Xanthan Gum, Polyhydroxystearic Acid, Fragrance, Chlorphenesin, Triethoxycaprylylsilane, Disodium EDTA, Sea Salt, Psidium Guajava Fruit Extract, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract.

Other information

protect this product from excessive heat and direct sun

Questions or comments?

Call 1-800-NO UV RAY, Mon-Fri

Principal Display Panel

NEW

HAWAIIAN

Tropic®

Matte

EFFECT

MINERAL ENRICHED SUNSCREEN LOTION SPF 50+

Non-Greasy & Lightweight

50+

SPF 50+ Broad Spectrum

UVA & UVB PROTECTION

Reef Friendly*

with naturally sourced sea minerals

6 FL.OZ. (177 mL)

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC MATTE EFFECT MINERAL ENRICHED SUNSCREEN SPF 50 
homosalate,octisalate,octocrylene,zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-542
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5.75 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.395 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
GUAVA (UNII: 74O70D6VG0)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
PAPAYA (UNII: KU94FIY6JB)
WATER (UNII: 059QF0KO0R)
PEG-100 STEARATE (UNII: YD01N1999R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALCOHOL (UNII: 3K9958V90M)
MANGO (UNII: I629I3NR86)
ISOHEXADECANE (UNII: 918X1OUF1E)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-542-24	6 g in 1 TUBE; Type 0: Not a Combination Product	08/14/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/14/2019

Labeler - Edgewell Personal Care Brands LLC (151179769)