HAWAIIAN TROPIC- octocrylene, oxybenzone 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

Octocrylene 1.0%, Oxybenzone 0.5%

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

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Inactive Ingredients

Water, Petrolatum, Diisopropyl Adipate, Propylene Glycol, Polyglyceryl-3 Methylglucose Distearate, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Benzyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea) Butter, Disodium EDTA, PEG-8 Dimethicone, Aloe Barbadensis Leaf Juice Powder, 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, Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Methylparaben, Propylparaben, Quaternium-15, Fragrance.

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

TANNING

lotion sunscreen

SPF 4

4

water resistant (80 minutes)

exotic island botanicals

protect pamper nourish

INGREDIENTS AND APPEARANCE

HAWAIIAN TROPIC 
octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-980
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETYL ALCOHOL (UNII: 936JST6JCN)
TROLAMINE (UNII: 9O3K93S3TK)
BENZYL ALCOHOL (UNII: LKG8494WBH)
QUATERNIUM-15 (UNII: E40U03LEM0)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
METHYLPARABEN (UNII: A2I8C7HI9T)
THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)
SHEA BUTTER (UNII: K49155WL9Y)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARICA PAPAYA WHOLE (UNII: S0U63B0Q51)
COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)
MANGO (UNII: I629I3NR86)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
PSIDIUM GUAJAVA WHOLE (UNII: 4J570BB45U)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332)
OCTYLDODECANOL (UNII: 461N1O614Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-980-11	59 g in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2010
2	NDC: 63354-980-53	117 g in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2010	01/01/2014
3	NDC: 63354-980-56	234 g in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2010
4	NDC: 63354-980-57	316 g in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/28/2010

Labeler - Edgewell Personal Care Brands LLC (151179769)