HAWAIIAN TROPIC SPF 15- avobenzone,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%, Octisalate 3%, Octocrylene 2%

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

Water, Polyglyceryl-3 Methylglucose Distearate, Caprylic/Capric Triglyceride, Ethylhexyl Benzoate, Propylene Glycol, Phenethyl Benzoate, Phenoxyethanol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Glyceryl Stearate, PEG-100 Stearate, Fragrance, Methylparaben, Sodium Polyacrylate, Benzyl Alcohol, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Propylparaben, Theobroma Cacao (Cocoa) Seed Butter, Disodium EDTA,Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice Powder, Panthenol, 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.

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

PROTECTIVE

Spray Lotion Sunscreen

BROAD SPECTRUM

SPF 15

15

UVA & UVB protection

water resistant (80 minutes)

Protect Pamper Nourish

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC  SPF 15
avobenzone,octisalate,octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SHEA BUTTER (UNII: K49155WL9Y)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
PANTHENOL (UNII: WV9CM0O67Z)
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCOA BUTTER (UNII: 512OYT1CRR)
CARICA PAPAYA WHOLE (UNII: S0U63B0Q51)
MANGIFERA INDICA WHOLE (UNII: U34MFR958F)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
PSIDIUM GUAJAVA WHOLE (UNII: 4J570BB45U)
2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENETHYL BENZOATE (UNII: 0C143929GK)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
COCONUT OIL (UNII: Q9L0O73W7L)
PEG-100 STEARATE (UNII: YD01N1999R)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-101-15	201 g in 1 BOTTLE; Type 0: Not a Combination Product	07/23/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/23/2014

Labeler - Edgewell Personal Care Brands LLC (151179769)