HAWAIIAN TROPIC- avobenzone, homosalate, octisalate, octocrylene, oxybenzone oil

Hawaiian Tropic by

Drug Labeling and Warnings

Hawaiian Tropic 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

Avobenzone 3.0%, Homosalate 5.0%, Octisalate 5.0%, Octocrylene 2.4%, Oxybenzone 4.0%

Purpose

Sunscreen

Uses

Helps prevent sunburn

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 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

Mineral Oil, Ethylhexyl Palmitate, Diisopropyl Adipate, Isopropyl Myristate, Silica, Cocos Nucifera (Coconut) Oil, Polybutene, Theobroma Cacao (Cocoa) Seed Butter, Glycine Soja (Soybean) Oil, Zea Mays (Corn) Oil, Arginine, Histidine, Phenyl Trimethicone, Tartaric acid, Aloe Barbadensis Leaf Extract, Daucus Carota Sativa (Carrot) Root Extract, PEG-8 Dimethicone, Carica Papaya (Papaya) Fruit Extract, Colocasia Antiquorum Root Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Beta-Carotene, Octyldodecanol, Retinyl Palmitate, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Fragrance, Red 17, Yellow 11.

Other Information

Protect this product from excessive heat and direct sun

Questions or Comments?

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

Front Label

HAWAIIAN

Tropic

PROTECTIVE

Dry Oil

bROAD SPECTRUM

SPF 15

15

UVA & UVB PROTECTION

a rare blend of nature's rich oils

indulge Pamper Nourish

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-260
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.4 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SOYBEAN OIL (UNII: 241ATL177A)
CORN OIL (UNII: 8470G57WFM)
ARGININE (UNII: 94ZLA3W45F)
HISTIDINE (UNII: 4QD397987E)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TARTARIC ACID (UNII: W4888I119H)
.BETA.-CAROTENE (UNII: 01YAE03M7J)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
CARROT (UNII: L56Z1JK48B)
D&C RED NO. 17 (UNII: ND733RX3JN)
D&C YELLOW NO. 11 (UNII: 44F3HYL954)
COCOA BUTTER (UNII: 512OYT1CRR)
MINERAL OIL (UNII: T5L8T28FGP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
MANGIFERA INDICA WHOLE (UNII: U34MFR958F)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
COCONUT OIL (UNII: Q9L0O73W7L)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARICA PAPAYA WHOLE (UNII: S0U63B0Q51)
COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
PSIDIUM GUAJAVA WHOLE (UNII: 4J570BB45U)
OCTYLDODECANOL (UNII: 461N1O614Y)
SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
ETHYLHEXYL PALMITATE (UNII: 2865993309)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-260-16	214 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/03/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/03/2012

Labeler - Edgewell Personal Care Brands LLC (151179769)