Label: HAWAIIAN TROPIC- avobenzone,octocrylene spray
- NDC Code(s): 63354-805-14
- Packager: Edgewell Personal Care Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 27, 2024
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- Active Ingredients
- Purpose
- Uses
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Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. For external use only.
Flammable: Do not puncture or incinerate container. Contents under pressure. Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking. Do not expose to heat or store at temperatures above 120°F.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 • Children under 6 months: Ask a doctor
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Inactive Ingredients
Mineral Oil, Ethylhexyl Palmitate, C12-15 Alkyl Benzoate, Isopropyl Myristate, Silica, Cocos Nucifera (Coconut) Oil, Fragrance, Theobroma Cacao (Cocoa) Seed Butter, Amyl Acetate, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Carica Papaya (Papaya) Fruit Extract, Colocasia Antiquorum Root Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Water, Panthenol.
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INGREDIENTS AND APPEARANCE
HAWAIIAN TROPIC
avobenzone,octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-805 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MINERAL OIL (UNII: T5L8T28FGP) MANGO (UNII: I629I3NR86) COCONUT OIL (UNII: Q9L0O73W7L) COCOA BUTTER (UNII: 512OYT1CRR) ETHYLHEXYL PALMITATE (UNII: 2865993309) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PAPAYA (UNII: KU94FIY6JB) COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D) PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P) GUAVA (UNII: 74O70D6VG0) WATER (UNII: 059QF0KO0R) PANTHENOL (UNII: WV9CM0O67Z) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) AMYL ACETATE (UNII: 92Q24NH7AS) ALOE VERA LEAF (UNII: ZY81Z83H0X) PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-805-14 158 g in 1 CAN; Type 0: Not a Combination Product 10/31/2023 10/01/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/31/2023 10/01/2025 Labeler - Edgewell Personal Care Brands LLC (151179769)
