HAWAIIAN TROPIC- avobenzone homosalate octisalate octocrylene lotion

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 1.5%, Homosalate 3.0%,Octisalate 4.5%, Octocrylene 3.0%

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

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 ocurs

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

Water, Cetearyl Alcohol, Phenoxyethanol,VP/Eicosene Copolymer, Mica, Diisopropyl Adipate, Ethylhexyl Benzoate, Glycerin, Fragrance, Neopentyl Glycol Diheptanoate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Methylparaben, Coco-Glucoside, Dimethicone, Polymethylsilsesquioxane,Propylparaben, Sodium Hydroxide, Ceteth-10 Phosphate, Dicetyl Phosphate, Propylene Glycol Dibenzoate, Disodium EDTA, Paraffin, Xanthan Gum, Butyrospermum Parkii (Shea) Butter, Jojoba Alcohol,Potassium Jojobate, Simmondsia Chinensis (Jojoba) Butter, Mangifera Indica (Mango) Seed Butter, Propanediol, Tocopheryl Acetate, 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, Panthenol, Aloe Barbadensis Leaf Juice, Sodium Ascorbyl Phosphate, Titanium Dioxide.

Other Information

Protect this product from excessive heat and direct sun

Questions or Comments?

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

PDP

HAWAIIAN

Tropic

Sheer Touch

Lotion Sunscreen

ULTRA RADIANCE

PROTECTS, SOFTENS

LEAVES SKIN RADIANT

15

BROAD SPECTRUM

SPF15

UVA & UVB protection

non-greasy

oil free

water resistant

(80 minutes)

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC 
avobenzone homosalate octisalate octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-601
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
METHYLPARABEN (UNII: A2I8C7HI9T)
COCO GLUCOSIDE (UNII: ICS790225B)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
PROPYLENE GLYCOL DIBENZOATE (UNII: EQY32Z1AN4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PARAFFIN (UNII: I9O0E3H2ZE)
XANTHAN GUM (UNII: TTV12P4NEE)
SHEA BUTTER (UNII: K49155WL9Y)
JOJOBA BUTTER (UNII: XIA46H803R)
MANGO (UNII: I629I3NR86)
PAPAYA (UNII: KU94FIY6JB)
PSIDIUM GUAJAVA WHOLE (UNII: 4J570BB45U)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
PROPANEDIOL (UNII: 5965N8W85T)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
PANTHENOL (UNII: WV9CM0O67Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-601-56	236 g in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2016
2	NDC: 63354-601-37	319 g in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/04/2016

Labeler - Edgewell Personal Care Brands LLC (151179769)