Label at a glance#

ProductHawaiian Tropic Island Sport SPF 30 for Canada

Active ingredientOCTOCRYLENE, OXYBENZONE, AVOBENZONE

Label structure7 sections

Dosage and administration

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.

Contacts and useful links#

Websitewww.hawaiiantropic.com

www.hawaiiantropic.com

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 0.077mL / 1mL

Oxybenzone 0.03mL / 1mL

Avobenzone 0.01mL / 1mL

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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:

PRECAUTIONS SECTION

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 :

INDICATIONS & USAGE SECTION

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 :

WARNINGS SECTION

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 50 ºC.

NON-MEDICINAL INGREDIENTS/INGRÉDIENTS NON MÉDICINAUX:

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAWAIIAN
Tropic^®
ISLAND
sport^TM
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

PRINCIPAL DISPLAY PANEL Hawaiian Tropic Island Sport SPF 30 for Canada

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17630-2038-1	2020-01-31	C162847	48780-1	9d75b9d0-b557-f424-e053-dadaa90a57ce	Hawaiian Tropic Island Sport SPF 30 for Canada

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17630-2038-1	Hawaiian Tropic Island Sport SPF 30 for Canada	180 mL in 1 CAN	SPRAY	180		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17630-2038	HAWAIIAN TROPIC ISLAND SPORT SPF 30 FOR CANADA (OCTOCRYLENE AND OXYBENZONE AND AVOBENZONE) SPRAY [ACCRA-PAC, INC.]	1	Legacy NDC, 1 package rows	20100330_a2ea1baf-927c-4061-b00c-45c6440be6ba.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	1
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	1
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	1
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	1
GUAVA	INACTIVE INGREDIENT	74O70D6VG0	1
MANGO	INACTIVE INGREDIENT	I629I3NR86	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	1
OCTYLDODECANOL	INACTIVE INGREDIENT	461N1O614Y	1
PAPAYA	INACTIVE INGREDIENT	KU94FIY6JB	1
PASSIFLORA INCARNATA TOP	INACTIVE INGREDIENT	CLF5YFS11O	1
PLUMERIA EXTRACT	INACTIVE INGREDIENT	LGC8P2PC4H	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

Hawaiian Tropic Island Sport SPF 30 for Canada
Octocrylene and Oxybenzone and Avobenzone
OCTOCRYLENE
OXYBENZONE
AVOBENZONE
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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
17630-2038	17630-2038-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTOCRYLENE	5A68WGF6WM	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB
AVOBENZONE	G63QQF2NOX	ACTIB
CAPRYLYL GLYCOL	00YIU5438U	IACT
VITAMIN A PALMITATE	1D1K0N0VVC	IACT
ASCORBIC ACID	PQ6CK8PD0R	IACT
.ALPHA.-TOCOPHEROL ACETATE, D-	A7E6112E4N	IACT
OCTYLDODECANOL	461N1O614Y	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
PAPAYA	KU94FIY6JB	IACT
MANGO	I629I3NR86	IACT
PLUMERIA EXTRACT	LGC8P2PC4H	IACT
GUAVA	74O70D6VG0	IACT
PASSIFLORA INCARNATA TOP	CLF5YFS11O	IACT
MINERAL OIL	T5L8T28FGP	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 113 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM, EXTENDED RELEASE / TRANSDERMAL	34 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	GEL / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE PARTICLES / ORAL		170 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	TABLET / ORAL		80 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	PASTE / TOPICAL	47.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / VAGINAL	30 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	0.11 %w/w		Exact identifier — unii candidate 25 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	POWDER, FOR SOLUTION / ORAL		560 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	CREAM / VAGINAL	13.5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CREAM / VAGINAL		402 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	SYRUP / ORAL		200 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	GEL / TOPICAL		7 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	TABLET, ORALLY DISINTEGRATING / ORAL	2.35 mg		Exact identifier — unii candidate 25 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING / ORAL		68 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	CREAM / TOPICAL		160 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SOLUTION / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.1 %w/w		Exact identifier — unii candidate 25 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SOLUTION / ORAL		280 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	SUPPOSITORY / RECTAL	3 mg		Exact identifier — unii candidate 25 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, CHEWABLE / ORAL		6 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	PASTE / DENTAL	95 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / OPHTHALMIC	59.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / ORAL		300 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	SOLUTION / ORAL		600 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SOAP / TOPICAL	0.82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		1440 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	SOLUTION / TOPICAL	0.04 %w/w		Exact identifier — unii candidate 25 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SUSPENSION / ORAL		2553 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM / TRANSDERMAL	11.42 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	CAPSULE / ORAL	7 mg		Exact identifier — unii candidate 25 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	CONCENTRATE / ORAL	6 mg/1ml		Exact identifier — unii candidate 25 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	INJECTION, SOLUTION / INTRAVENOUS		4 mg	Exact identifier — unii candidate 25 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e0df89ba-63cb-424c-9ead-a1188320a0ce			a2ea1baf-927c-4061-b00c-45c6440be6ba	2010-03-28	Warnings	Exact identifier spl id: e0df89ba-63cb-424c-9ead-a1188320a0ce spl set id: a2ea1baf-927c-4061-b00c-45c6440be6ba

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.