Label: HAWAIIAN TROPIC- avobenzone,homosalate,octisalate,octocrylene aerosol, spray
- NDC Code(s): 63354-613-34
- Packager: Edgewell Personal Care Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 30, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children.
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Directions
• Shake well • Hold container 4 to 6 inches from the skin to apply • Spray liberally and spread evenly by hand 15 minutes before sun exposure • Do not spray directly into face. Spray on hands then apply to face. • Do not apply in windy conditions • Use in well-ventilated area • Reapply: • After 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours Sun Protection Measures. • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeve shirts, pants, hats and sunglasses. • Children under 6 months: Ask a doctor.
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Inactive Ingredients
Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, Mineral Oil, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Lauryl PEG-8 Dimethicone, Caprylyl Glycol, Methyl Dihydroabietate, Fragrance, Argania Spinosa Kernel Oil, Olea Europaea (Olive) Fruit Oil, Vitis Vinifera (Grape) Seed Oil, Ascorbyl Palmitate, Tocopheryl Acetate, Cocos Nucifera (Coconut) Oil, Glycine Soja (Soybean) Oil, Panthenol, Water, Psidium Guajava Fruit Extract, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Aloe Barbadensis Leaf Extract, Daucus Carota Sativa (Carrot) Root Extract.
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INGREDIENTS AND APPEARANCE
HAWAIIAN TROPIC
avobenzone,homosalate,octisalate,octocrylene aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-613 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 6 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 6 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g Inactive Ingredients Ingredient Name Strength ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBYL PALMITATE (UNII: QN83US2B0N) ALOE VERA LEAF (UNII: ZY81Z83H0X) PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P) PAPAYA (UNII: KU94FIY6JB) CARROT (UNII: L56Z1JK48B) ISODODECANE (UNII: A8289P68Y2) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PANTHENOL (UNII: WV9CM0O67Z) MANGO (UNII: I629I3NR86) LAURYL PEG-8 DIMETHICONE (300 CPS) (UNII: ELL2U7K8T8) SOYBEAN OIL (UNII: 241ATL177A) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) GRAPE SEED OIL (UNII: 930MLC8XGG) OLIVE OIL (UNII: 6UYK2W1W1E) PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H) GUAVA (UNII: 74O70D6VG0) ARGAN OIL (UNII: 4V59G5UW9X) ISOBUTANE (UNII: BXR49TP611) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) MINERAL OIL (UNII: T5L8T28FGP) COCONUT OIL (UNII: Q9L0O73W7L) GLYCERYL OLEATE (UNII: 4PC054V79P) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-613-34 170 g in 1 CAN; Type 0: Not a Combination Product 10/31/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/31/2023 Labeler - Edgewell Personal Care Brands LLC (151179769)