Label: HAWAIIAN TROPIC- avobenzone,homosalate,octisalate,octocrylene aerosol, spray
- NDC Code(s): 63354-232-34
- Packager: Edgewell Personal Care Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 31, 2023
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- Active Ingredients
- Purpose
- Uses
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Warnings
For external use only
Flammable: Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120 oF. Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking.
May stain some fabrics and surfaces.
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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 value 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-sleeved shirts, pants, hats, and sunglasses • Children under 6 months: Ask a doctor
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Inactive Ingredients:
Alcohol Denat., Isobutane, Isododecane, C12-15 Alkyl Benzoate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Dimethicone, Fragrance, Tocopheryl Acetate, Ascorbyl Palmitate, Mineral Oil, Water, Panthenol, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Aloe Barbadensis Leaf 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:63354-232 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.7 g in 100 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) GLYCERYL OLEATE (UNII: 4PC054V79P) ALOE VERA LEAF (UNII: ZY81Z83H0X) PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H) GUAVA (UNII: 74O70D6VG0) ASCORBYL PALMITATE (UNII: QN83US2B0N) PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P) ISOBUTANE (UNII: BXR49TP611) ISODODECANE (UNII: A8289P68Y2) WATER (UNII: 059QF0KO0R) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MANGO (UNII: I629I3NR86) ALCOHOL (UNII: 3K9958V90M) PANTHENOL (UNII: WV9CM0O67Z) PAPAYA (UNII: KU94FIY6JB) DIMETHICONE (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-232-34 170 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)
