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Hawaiian Tropic Island Sport SPF 30 for Canada

Dosage form: spray
Ingredients: OCTOCRYLENE 0.077mL in 1mL, OXYBENZONE 0.03mL in 1mL, AVOBENZONE 0.01mL in 1mL
Labeler: Accra-Pac, Inc.
NDC Code: 17630-2038

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.

Hawaiian Tropic Island Sport SPF 30 for Canada

Active Ingredients

Octocrylene 0.077mL / 1mL

Oxybenzone 0.03mL / 1mL

Avobenzone 0.01mL / 1mL

DIRECTIONS:

Shake well. Do not spray directly on face. Spray into hands, and apply to the face. Apply liberally and rub into skin 15 to 30 minutes before sun exposure. Reapply frequently. Reapply after swimming, excessive perspiration, washing or toweling.

CAUTION:

FOR EXTERNAL USE ONLY. Discontinue use if skin irritation develops or increases. If irritation persists, consult your doctor. Avoid contact with eyes. Flush immediately with water if contact occurs. For use on children under 6 months of age, consult your doctor. Keep out of the reach of children. May stain certain surfaces and fabrics. Use only in a well-ventilated area. Do not use in the presence of open flame or spark. Contents under pressure. Do not place in hot water or near radiators, stoves or other sources of heat. Do not puncture or incinerate container or store at temperatures over 50ºC.

MODE D’EMPLOI :

Bien agiter. Ne pas vaporiser directement sur le visage. Vaporiser d’abord le produit dans les mains, puis appliquer sur le visage. Appliquer généreusement de 15 à 30 minutes avant l’exposition au soleil et faire pénétrer dans la peau en frottant. Réappliquer fréquemment. Réappliquer après une baignade, une forte transpiration, s’être séché à la serviette ou s’être lavé.

MISE EN GARDE :

POUR USAGE EXTERNE SEULEMENT. Cesser l’emploi du produit si une irritation cutanée apparaît ou si elle s’aggrave. Si l’irritation persiste, consulter un médecin. Éviter tout contact avec les yeux. En cas de contact, rincer immédiatement avec de l’eau. Consulter un médecin avant d’utiliser pour un enfant de moins de six mois. Garder hors de la portée des enfants. Ce produit peut abîmer certaines surfaces et certains tissus. N’utiliser que dans un endroit bien aéré. Ne pas utiliser en présence d’une flamme nue ou d’étincelles. Contenu sous pression. Ne pas mettre dans l’eau chaude ni près des radiateurs, poêles ou autres sources de chaleur. Ne pas percer le contenant ni le jeter au feu, ni le conserver à des températures dépassant 50ºC.

NON-MEDICINAL INGREDIENTS/INGRÉDIENTS NON MÉDICINAUX:

Alcohol Denat., Acrylates/Octylacrylamide Copolymer, Caprylyl Glycol, Retinyl Palmitate, Ascorbic Acid, Tocopheryl Acetate, PEG-8 Dimethicone, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Octyldodecanol, Silica, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Plumeria Acutifolia Flower Extract, Colocasia Antiquorum Root Extract, Psidium Guajava Fruit Extract, Passiflora Incarnata Fruit Extract, Paraffinum Liquidum, Aloe Barbadensis Leaf Extract, Parfum.

Distributed by/Distribué par
ENERGIZER CANADA INC.
Walkerton, ON N0G 2V0
Made in U.S.A./Fabriqué aux États-Unis
© 2009 Tanning Research
Laboratories, LLC
1-800-NO-UV-RAY
www.hawaiiantropic.com

PRINCIPAL DISPLAY PANEL

HAWAIIAN
Tropic
®
ISLAND

sportTM
Clear Sunscreen Spray

Écran solaire transparent
en
vaporisateur
30 SPF/FPS

UVA/UVB waterproof

hydrates skin

UVA et UVB
hydrofuge
hydrate la
peau
180
mL

HAWAIIAN TROPIC ISLAND SPORT SPF 30 FOR CANADA 
octocrylene and oxybenzone and avobenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17630-2038
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE0.077 mL  in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE0.03 mL  in 1 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE0.01 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CAPRYLYL GLYCOL 
VITAMIN A PALMITATE 
ASCORBIC ACID 
.ALPHA.-TOCOPHEROL ACETATE, D- 
OCTYLDODECANOL 
SILICON DIOXIDE 
PAPAYA 
MANGO 
PLUMERIA EXTRACT 
GUAVA 
PASSIFLORA INCARNATA TOP 
MINERAL OIL 
ALOE VERA LEAF 
Packaging
#Item CodePackage Description
1NDC:17630-2038-1180 mL in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35210/03/2009
Labeler - Accra-Pac, Inc. (024213616)
Establishment
NameAddressID/FEIOperations
Accra-Pac, Inc.024213616MANUFACTURE

Revised: 03/2010
 
Accra-Pac, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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