Label: HAWAIIAN TROPIC- avobenzone,homosalate,octocrylene spray
- NDC Code(s): 63354-324-14
- Packager: Edgewell Personal Care Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 4, 2023
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- Active Ingredient
- Purpose
- Uses
- Warnings
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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 and then apply to face. • Do not apply in windy conditions • Use in a 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 -
Inactive Ingredients
Water, Diisopropyl Adipate, Butyloctyl Salicylate, Butylene Glycol, Polyglyceryl-3 Methylglucose Distearate, Oryza Sativa (Rice) Starch, Phenoxyethanol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Chlorphenesin, PEG-100 Stearate, Glyceryl Stearate, Fragrance, Sodium Polyacrylate, Glycerin, Aloe Barbadensis Leaf Juice Powder, Disodium EDTA, Sodium Hyaluronate, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Psidium Guajava Fruit Extract, Plumeria Acutifolia Flower Extract.
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INGREDIENTS AND APPEARANCE
HAWAIIAN TROPIC
avobenzone,homosalate,octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-324 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 8 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 6 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.7 g in 100 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) EDETATE DISODIUM (UNII: 7FLD91C86K) PAPAYA (UNII: KU94FIY6JB) PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) HYALURONATE SODIUM (UNII: YSE9PPT4TH) GUAVA (UNII: 74O70D6VG0) PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H) WATER (UNII: 059QF0KO0R) STARCH, RICE (UNII: 4DGK8B7I3S) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-100 STEARATE (UNII: YD01N1999R) ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) MANGO (UNII: I629I3NR86) GLYCERIN (UNII: PDC6A3C0OX) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-324-14 153 g in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/01/2023 Labeler - Edgewell Personal Care Brands LLC (151179769)
