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

Warnings

For external use only

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 specrum 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

May stain some fabrics

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

Children under 6

Inactive ingredients

Water, Isohexadecane, Diisopropyl Adipate, Ethylhexyl Benzoate, Butylene Glycol,Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cetearyl Alcohol,Acrylates/C12-22 Alkyl Methacrylate Copolymer, Phenoxyethanol, Caprylyl Glycol,Fragrance, Methylparaben, Ceteth-10 Phosphate, Dicetyl Phosphate, Propylparaben,Polysorbate 60, Disodium EDTA, Xanthan Gum, Aminomethyl Propanol, Mica, Tocopheryl Acetate, Titanium Dioxide, Panthenol, Aloe Barbadensis Leaf Juice, Silk Amino Acids, Sodium Ascorbyl Phosphate, 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, Iron Oxides.

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

HAWAIIAN

Tropic

Silk

HYDRATION

Lotion Sunscreen

WEIGHTLESS

Feels as if its barely on

BROAD SPECTRUM

SPF 15

12 HOUR Moisturization*

with hydrating ribbons

UVA & UVB protection

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-229
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYSORBATE 60 (UNII: CAL22UVI4M)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
MICA (UNII: V8A1AW0880)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PANTHENOL (UNII: WV9CM0O67Z)
AMINO ACIDS, SILK (UNII: V0L00EX1IA)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
PAPAYA JUICE (UNII: AZ5XLY17KM)
MANGIFERA INDICA WHOLE (UNII: U34MFR958F)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
PSIDIUM GUAJAVA WHOLE (UNII: 4J570BB45U)
ISOHEXADECANE (UNII: 918X1OUF1E)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-229-14	150 g in 1 BOTTLE; Type 0: Not a Combination Product	01/02/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/02/2018

Labeler - Edgewell Personal Care Brands LLC (151179769)