HAWAIIAN TROPIC - avobenzone, octocrylene and oxybenzone stick
Energizer Personal Care LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients

Avobenzone 1%
Octocrylene 10%
Oxybenzone 6%

Purpose

Sunscreen

Use

Higher SPF gives more sunburn protection
helps prevent sunburn
retains SPF after 80 minutes of activity in the water or perspiring.

Warnings

For external use only

When using this product

do not get into eyes. If contact occurs, rinse throughly with water

stop use and ask a doctor if

irritation or rash develops

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply generously and evenly to lips, nose and ears before sun exposure
for children under six months of age: ask a doctor
reapply as needed or after towel drying, swimming or perspiring

Other Information

Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

May stain some fabrics.

Inactive Ingredients

Ozokerite, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Diisobutyl Adipate, Cetyl Alcohol, Cyclopentasiloxane, Cyclohexasiloxane, Theobroma Cacao (Cocoa) Seed Butter, Flavor, Adipic Acid/Diethylene Glycol/Glycerin Crosspolymer, Isostearyl Linoleate, Dimethicone, PEG-8, Sodium Saccharin, Propylparaben, Aloe Barbadensis Leaf Extract, BHT, Mineral Oil, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Plumeria Acutifolia (Plumeria) Flower Extract, Colocasia Antiquorum Root Extract, Psidium Guajava (Guava) Fruit Extract, Passiflora Incarnata (Passionflower) Fruit Extract, Retinyl Palmitate (Vitamin A), Ascorbic Acid (Vitamin C), Tocopheryl Acetate (Vitamin E), PEG-8 Dimethicone, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Octyldodecanol, Silica.

Questions or Comments?

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

Principal Display Panel

Tear Here

TROPICAL
flavor

HAWAIIAN Tropic®
LIP BALM
Stick Sunscreen

45+
UVB/SPF
WITH UVA

moisturizing
very water resistant

SUNSURE PROTECTIONTM

NET WT .14 OZ. (4 g)

HAWAIIAN TROPIC
avobenzone, octocrylene, oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63354-300
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (AVOBENZONE)	AVOBENZONE	1 g in 100 g
OCTOCRYLENE (OCTOCRYLENE)	OCTOCRYLENE	10 g in 100 g
OXYBENZONE (OXYBENZONE)	OXYBENZONE	6 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYL PALMITATE
MEDIUM-CHAIN TRIGLYCERIDES
DIISOBUTYL ADIPATE
CETYL ALCOHOL
CYCLOMETHICONE 5
CYCLOMETHICONE 6
DIMETHICONE
POLYETHYLENE GLYCOL 400
SACCHARIN SODIUM
PROPYLPARABEN
ALOE VERA LEAF
BUTYLATED HYDROXYTOLUENE
MINERAL OIL
PAPAYA
MANGO
PLUMERIA RUBRA FLOWER
COLOCASIA ESCULENTA ROOT
GUAVA
PASSIFLORA INCARNATA FRUIT
VITAMIN A PALMITATE
ASCORBIC ACID
.ALPHA.-TOCOPHEROL ACETATE, DL-
OCTYLDODECANOL
SILICON DIOXIDE

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:63354-300-61	3.97 g in 1 BLISTER PACK	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/06/2012

Labeler - Energizer Personal Care LLC (021718141)

Establishment
Name	Address	ID/FEI	Operations
OraLabs, Inc		801824756	manufacture

Revised: 01/2012 Energizer Personal Care LLC