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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Drug Facts

Active Ingredients

Avobenzone 1%
Octocrylene 10%
Oxybenzone 6%

Purpose

Sunscreen

Uses

helps prevent sunburn

Warnings

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

Directions

Other Information

Sun Protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease theis risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

Inactive Ingredients

Ozokerite, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Diisobutyl Adipate, Cetyl Alcohol, Cyclopentasiloxane, Theobroma Cacao (Cocoa) Seed Butter, Adipic Acid/Diglycol Crosspolymer, Dimethicone, Flavor, Isostearyl Linoleate, Cyclohexasiloxane, PEG-8, Silica, Sodium Saccharin, BHT, Mineral Oil, PEG-8 Dimethicone, Cocos Nucifera (Coconut) Oil, Aloe Barbadensis Leaf Extract, 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, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Propylparaben.

Questions or Comments?

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

Principal Display Panel

Tear Here

TROPICAL
flavor

HAWAIIAN Tropic®
LIP BALM
Stick Sunscreen

Broad SPectrum
SPF 45+

45+
UVB & UVB
protection

water resistant
(80 minutes)

63354-300-61
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 (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIISOBUTYL ADIPATE (UNII: 8OPY05ZY7S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MINERAL OIL (UNII: T5L8T28FGP)  
PAPAYA (UNII: KU94FIY6JB)  
MANGO (UNII: I629I3NR86)  
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)  
COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)  
GUAVA (UNII: 74O70D6VG0)  
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63354-300-63 4 g in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/11/2012
Labeler - Energizer Personal Care LLC (021718141)

Revised: 10/2012
Document Id: 43f62e90-5e0d-4708-bc1c-7f108c2f104b
Set id: b7ac1c60-6f6e-4c19-9ffe-dd1c548ac6b1
Version: 4
Effective Time: 20121009
 
Energizer Personal Care LLC